Clinical guideline for the evaluation of chronic insomnia in adults. J Clin Sleep Med 4:487-504

Abstract

Insomnia is the most prevalent sleep disorder in the general population, and is commonly encountered in medical practices. Insomnia is defined as the subjective perception of difficulty with sleep initiation, duration, consolidation, or quality that occurs despite adequate opportunity for sleep, and that results in some form of daytime impairment.1 Insomnia may present with a variety of specific complaints and etiologies, making the evaluation and management of chronic insomnia demanding on a clinician's time. The purpose of this clinical guideline is to provide clinicians with a practical framework for the assessment and disease management of chronic adult insomnia, using existing evidence-based insomnia practice parameters where available, and consensus-based recommendations to bridge areas where such parameters do not exist. Unless otherwise stated, "insomnia" refers to chronic insomnia, which is present for at least a month, as opposed to acute or transient insomnia, which may last days to weeks.

Full text

Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 487
SUMMARY RECOMMENDATIONS
General:
 Insomnia is an important public health problem that re-
quires accurate diagnosis and effective treatment. (Stan-
dard)
 An insomnia diagnosis requires associated daytime dys-
function in addition to appropriate insomnia symptomatol-
ogy. (ICSD-2 denition)
Evaluation:
 Insomnia is primarily diagnosed by clinical evaluation
through a thorough sleep history and detailed medical, sub-
stance, and psychiatric history. (Standard)
• Thesleephistoryshouldcoverspecicinsomniacom-
plaints, pre-sleep conditions, sleep-wake patterns, oth-
er sleep-related symptoms, and daytime consequences.
(Consensus)
• Thehistoryhelpstoestablish thetype andevolution
ofinsomnia,perpetuatingfactors,andidenticationof
comorbid medical, substance, and/or psychiatric con-
ditions. (Consensus)
 Instruments which are helpful in the evaluation and dif-
ferential diagnosis of insomnia include self-administered
questionnaires, at-home sleep logs, symptom checklists,
psychological screening tests, and bed partner interviews.
(Guideline)
• Atminimum,thepatientshouldcomplete:(1)Agen-
eral medical/psychiatric questionnaire to identify co-
morbiddisorders(2)TheEpworthSleepinessScaleor
other sleepiness assessment to identify sleepy patients
andcomorbiddisordersofsleepiness(3)Atwo-week
sleep log to identify general patterns of sleep-wake
times and day-to-day variability. (Consensus)
• Sleepdiarydatashouldbecollectedpriortoanddur-
ing the course of active treatment and in the case of
relapse or reevaluation in the long-term. (Consensus)
• Additionalassessmentinstrumentsthatmayaidinthe
baseline evaluation and outcomes follow-up of pa-
tients with chronic insomnia include measures of sub-
jective sleep quality, psychological assessment scales,
daytime function, quality of life, and dysfunctional
beliefs and attitudes. (Consensus)
 Physical and mental status examination may provide im-
portant information regarding comorbid conditions and
differential diagnosis. (Standard)
 Polysomnography and daytime multiple sleep latency test-
ing(MSLT)are notindicatedintheroutine evaluation of
chronic insomnia, including insomnia due to psychiatric or
neuropsychiatric disorders. (Standard)
• Polysomnography is indicated when there is reason-
able clinical suspicion of breathing (sleep apnea) or
movement disorders, when initial diagnosis is uncer-
tain,treatmentfails(behavioralorpharmacologic),or
precipitous arousals occur with violent or injurious
behavior. (Guideline)
Clinical Guideline for the Evaluation and Management of Chronic Insomnia in Adults
Sharon Schutte-Rodin, M.D.1; Lauren Broch, Ph.D.2; Daniel Buysse, M.D.3; Cynthia Dorsey, Ph.D.4; Michael Sateia, M.D.5
1Penn Sleep Centers, Philadelphia, PA; 2Good Samaritan Hospital, Suffern, NY; 3UPMC Sleep Medicine Center, Pittsburgh, PA; 4SleepHealth
Centers, Bedford, MA; 5Dartmouth-Hitchcock Medical Center, Lebanon, NH
Submitted for publication July, 2008
Accepted for publication July, 2008
Address correspondence to: Sharon L. Schutte-Rodin, M.D., Penn Sleep
Centers, University of Pennsylvania Health System, 3624 Market St., 2nd
Floor, Philadelphia, PA 19104; Tel: (215) 615-3669; Fax: (215) 615-4835;
E-mail: rodins@hphs.upenn.edu
SPECIAL ARTICLE
Insomnia is the most prevalent sleep disorder in the general popula-
tion, and is commonly encountered in medical practices. Insomnia is
dened as the subjective perception of difculty with sleep initiation,
duration, consolidation, or quality that occurs despite adequate oppor-
tunity for sleep, and that results in some form of daytime impairment.1
Insomnia may present with a variety of specic complaints and eti-
ologies, making the evaluation and management of chronic insomnia
demanding on a clinician’s time. The purpose of this clinical guideline
is to provide clinicians with a practical framework for the assessment
and disease management of chronic adult insomnia, using existing
evidence-based insomnia practice parameters where available, and
consensus-based recommendations to bridge areas where such pa-
rameters do not exist. Unless otherwise stated, “insomnia” refers to
chronic insomnia, which is present for at least a month, as opposed to
acute or transient insomnia, which may last days to weeks.
Citation: Schutte-Rodin S; Broch L; Buysse D; Dorsey C; Sateia M.
Clinical guideline for the evaluation and management of chronic in-
somnia in adults. J Clin Sleep Med 2008;4(5):487-504.

Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 488
S Schutte-Rodin, L Broch, D Buysse et al
 Actigraphy is indicated as a method to characterize circa-
dian rhythm patterns or sleep disturbances in individuals
with insomnia, including insomnia associated with depres-
sion. (Option)
 Otherlaboratorytesting(e.g.,blood,radiographic)isnotin-
dicated for the routine evaluation of chronic insomnia unless
there is suspicion for comorbid disorders. (Consensus)
Differential Diagnosis:
 Thepresence of one insomnia disorderdoes not exclude
other disorders, as multiple primary and comorbid insom-
nia disorders may coexist. (Consensus)
Treatment Goals/Treatment Outcomes:
 Regardlessofthetherapytype,primarytreatmentgoalsare:
(1)toimprovesleepqualityandquantityand(2)toimprove
insomnia related daytime impairments. (Consensus)
 Other specic outcome indicators for sleep generally in-
clude measures of wake time after sleep onset (WASO),
sleep onset latency (SOL), number of awakenings, sleep
timeor sleepefciency,formationofapositive andclear
association between the bed and sleeping, and improve-
ment of sleep related psychological distress. (Consensus)
 Sleep diary data should be collected prior to and during
the course of active treatment and in the case of relapse or
reevaluationinthelongterm(every6months).(Consen-
sus)
 In addition to clinical reassessment, repeated administra-
tion of questionnaires and survey instruments may be use-
ful in assessing outcome and guiding further treatment ef-
forts. (Consensus)
 Ideally, regardless of the therapy type, clinical reassess-
ment should occur every few weeks and/or monthly until
theinsomnia appearsstableor resolved,andthen every6
months, as the relapse rate for insomnia is high. (Consen-
sus)
 Whenasingletreatmentorcombinationoftreatmentshas
been ineffective, other behavioral therapies, pharmacologi-
cal therapies, combined therapies, or reevaluation for oc-
cult comorbid disorders should be considered. (Consen-
sus)
Psychological and Behavioral Therapies:
 Psychological and behavioral interventions are effective
and recommended in the treatment of chronic primary and
comorbid(secondary)insomnia.(Standard)
• These treatments are effective for adults of all ages,
including older adults, and chronic hypnotic users.
(Standard)
• Thesetreatmentsshouldbeutilizedasaninitialinter-
vention when appropriate and when conditions permit.
(Consensus)
 Initial approaches to treatment should include at least one
behavioral intervention such as stimulus control therapy or
relaxation therapy, or the combination of cognitive thera-
py, stimulus control therapy, sleep restriction therapy with
or without relaxation therapy—otherwise known as cogni-
tivebehavioraltherapyforinsomnia(CBT-I).(Standard)
 Multicomponent therapy (without cognitive therapy) is
effective and recommended therapy in the treatment of
chronic insomnia. (Guideline)
 Other common therapies include sleep restriction, para-
doxical intention, and biofeedback therapy. (Guideline)
 Although all patients with chronic insomnia should adhere
to rules of good sleep hygiene,thereisinsufcientevidence
to indicate that sleep hygiene alone is effective in the treat-
ment of chronic insomnia. It should be used in combination
with other therapies. (Consensus)
 When an initial psychological/ behavioral treatment has
been ineffective, other psychological/ behavioral therapies,
combination CBT-I therapies, combined treatments (see
below),oroccultcomorbiddisordersmaynextbeconsid-
ered. (Consensus)
Pharmacological Treatment:
 Short-term hypnotic treatment should be supplemented
with behavioral and cognitive therapies when possible.
(Consensus)
 Whenpharmacotherapyisutilized,thechoiceofaspecic
pharmacological agent within a class, should be directed
by:(1)symptompattern;(2)treatmentgoals;(3)pasttreat-
mentresponses;(4)patientpreference;(5)cost;(6)avail-
ability of other treatments; (7) comorbid conditions; (8)
contraindications;(9) concurrent medication interactions;
and(10)sideeffects.(Consensus)
 For patients with primary insomnia (psychophysiologic,
idiopathic or paradoxical ICSD-2 subtypes), when phar-
macologic treatment is utilized alone or in combination
therapy, the recommended general sequence of medication
trialsis: (Consensus)
• Short-intermediateactingbenzodiazepinereceptorago-
nists(BZDornewerBzRAs)orramelteon:examplesof
these medications include zolpidem, eszopiclone, zale-
plon, and temazepam
• Alternateshort-intermediateactingBzRAsorramelt-
eon if the initial agent has been unsuccessful
• Sedatingantidepressants,especiallywhenusedincon-
junction with treating comorbid depression/anxiety:
examples of these include trazodone, amitriptyline,
doxepin, and mirtazapine
• Combined BzRA or ramelteon and sedating antide-
pressant
• Othersedatingagents:examplesincludeanti-epilepsy
medications (gabapentin, tiagabine) and atypical an-
tipsychotics(quetiapineandolanzapine)
 These medications may only be suitable for pa-
tients with comorbid insomnia who may benet
from the primary action of these drugs as well as
from the sedating effect.
 Over-the-counter antihistamine or antihistamine/analgesic
typedrugs (OTC “sleepaids”) as well as herbal and nu-
tritionalsubstances(e.g., valerian and melatonin)arenot
recommended in the treatment of chronic insomnia due to
therelativelackofefcacyandsafetydata.(Consensus)

Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 489
Evaluation and Management of Chronic Insomnia in Adults
 Older approved drugs for insomnia including barbiturates,
barbiturate-type drugs and chloral hydrate are not recom-
mended for the treatment of insomnia. (Consensus)
 Thefollowingguidelinesapplytoprescriptionofallmedi-
cations for management of chronic insomnia: (Consen-
sus)
• Pharmacologicaltreatmentshouldbeaccompaniedby
patient education regarding: (1) treatment goals and
expectations; (2) safety concerns; (3) potential side
effectsanddruginteractions; (4)othertreatmentmo-
dalities(cognitiveandbehavioraltreatments);(5)po-
tentialfordosageescalation;(6)reboundinsomnia.
• Patientsshould befollowedonaregular basis,every
few weeks in the initial period of treatment when pos-
sible, to assess for effectiveness, possible side effects,
and the need for ongoing medication.
• Effortsshouldbemadetoemploythelowesteffective
maintenance dosage of medication and to taper medi-
cation when conditions allow.
 Medication tapering and discontinuation are fa-
cilitatedbyCBT-I.
• Chronichypnoticmedicationmaybeindicatedforlong-
term use in those with severe or refractory insomnia or
chroniccomorbidillness.Wheneverpossible,patients
should receive an adequate trial of cognitive behavioral
treatment during long-term pharmacotherapy.
 Long-termprescribingshouldbeaccompaniedby
consistent follow-up, ongoing assessment of ef-
fectiveness, monitoring for adverse effects, and
evaluation for new onset or exacerbation of exist-
ing comorbid disorders
 Long-termadministrationmaybenightly,intermit-
tent(e.g.,threenightsperweek),orasneeded.
Combined Treatments:
 The use of combined therapy (CBT-I plus medication)
shouldbedirectedby(1)symptompattern;(2)treatment
goals;(3)pasttreatmentresponses;(4)patientpreference;
(5)cost;(6)availabilityofothertreatments;(7)comorbid
conditions; (8) contraindications; (9) concurrent medica-
tioninteractions;and(10)sideeffects.(Consensus)
 Combinedtherapyshowsnoconsistentadvantageordis-
advantage over CBT-I alone. Comparisons to long-term
pharmacotherapy alone are not available. (Consensus)
INTRODUCTION
Insomnia symptoms occur in approximately 33% to 50% of
theadultpopulation;insomniasymptomswithdistressorim-
pairment(generalinsomniadisorder)in10%to15%.Consistent
risk factors for insomnia include increasing age, female sex, co-
morbid (medical, psychiatric, sleep, and substance use) disor-
ders, shift work, and possibly unemployment and lower socio-
economicstatus.“Insomnia”hasbeenusedindifferentcontexts
torefertoeitherasymptomoraspecicdisorder.Inthisguide-
line, an insomnia disorder is denedas a subjective report of
difcultywithsleepinitiation,duration,consolidation,orqual-
ity that occurs despite adequate opportunity for sleep, and that
resultsinsomeformofdaytimeimpairment.Becauseinsomnia
maypresentwithavarietyofspeciccomplaintsandcontribut-
ing factors, the time required for evaluation and management of
chronicinsomniacanbedemandingforclinicians.Thepurpose
of this clinical guideline is to provide clinicians with a frame-
work for the assessment and management of chronic adult in-
somnia, using existing evidence-based insomnia practice param-
eters where available, and consensus-based recommendations to
bridge areas where such parameters do not exist.
METHODS
Thisclinicalguidelineincludesbothevidence-basedandcon-
sensus-based recommendations. In the guideline summary rec-
ommendation section, each recommendation is accompanied by
itslevel ofevidence:standard,guideline,option,or consensus
based.“Standard,”“guideline,”and“option”recommendations
were incorporated from evidence-based American Academy of
SleepMedicine (AASM) practice parameter papers. “Consen-
sus”recommendationsweredevelopedusingamodiednomi-
nal group technique. The development of these recommenda-
tions and their appropriate use are described below.
Evidence-Based Practice Parameters
Inthe development of this guideline, existingAASM prac-
tice parameter papers relevant to the evaluation and manage-
ment of chronic insomnia in adults were incorporated.2-6These
practice parameter papers, many of which addressed specic
insomnia-related topics rather than providing a comprehensive
clinical chronic insomnia practice guideline for clinicians, were
previously developed via a computerized, systematic search of
thescienticliterature(forspecicsearchtermsandfurtherde-
tails,seereferencedpracticeparameter)andsubsequentcritical
review, evaluation, and evidence-grading of all pertinent stud-
ies.7
OnthebasisofthisreviewtheAASMStandardsofPractice
Committeedevelopedpracticeparameters.Practiceparameters
weredesignatedas“Standard,”“Guideline,”or“Option”based
onthequalityandamountofscienticevidenceavailable(Ta-
ble1).
Consensus-Based Recommendations
Consensus-basedrecommendationsweredevelopedforthis
clinical guideline to address important areas of clinical practice
thathadnotbeenthesubjectofapreviousAASMpracticeparam-
eter, or where the available empirical data was limited or incon-
clusive.Consensus-based recommendations reectthe shared
judgment of the committee members and reviewers, based on
the literature and common clinical practice of topic experts, and
weredevelopedusingamodiednominalgrouptechnique.An
expertinsomniapanelwasassembled bytheAASMto author
thisclinical guideline.Inaddition tousingallAASMpractice
parametersandAASM Sleep publications throughJuly2007,
the expert panel reviewed other relevant source articles from a
Medlinesearch(1999toOctober2006;alladultagesincluding
seniors;“insomniaand”keywordsrelatingtoevaluation,test-
ing, and treatments. Using a face-to-face meeting, voting sur-

Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 490
Table 2—DiagnosticCriteriaforInsomnia(ICSD-2)
A.Acomplaint of difcultyinitiating sleep, difculty maintain-Acomplaint of difculty initiating sleep, difculty maintain-
ing sleep, or waking up too early, or sleep that is chronically
nonrestorative or poor in quality.
B.Theabovesleepdifcultyoccursdespiteadequateopportunity
and circumstances for sleep.
C.At least oneofthefollowingforms of daytime impairmentre-
latedtothenighttimesleepdifcultyisreportedbythepatient:
1. Fatigueormalaise;
2. Attention,concentration,ormemoryimpairment;
3. Socialorvocationaldysfunctionorpoorschoolperformance;
4. Mooddisturbanceorirritability;
5. Daytimesleepiness;
6. Motivation,energy,orinitiativereduction;
7. Pronenessforerrors/accidentsatworkorwhiledriving;
8. Tension, headaches, or gastrointestinal symptoms in re-
sponsetosleeploss;and
9. Concernsorworriesaboutsleep.
treatment options, resources available, and other relevant fac-
tors.TheAASMexpects thisclinicalguidelinetohaveanim-
pactonprofessionalbehavior andpatientoutcomes.Itreects
the state of knowledge at the time of publication and will be
reviewed, updated, and revised as new information becomes
available.
INSOMNIA DEFINITIONS AND EPIDEMIOLOGY
Insomnia Definitions
“Insomnia” has been used in different contexts to refer to
either a symptom or a specic disorder.In this guideline, an
insomniadisorderisdenedasasubjectivereportofdifculty
with sleep initiation, duration, consolidation, or quality that oc-
curs despite adequate opportunity for sleep, and that result in
someformofdaytimeimpairment(Table2).
Exceptwhereotherwisenoted,theword“insomnia”refersto
an insomnia disorder in this guideline.
Insomnia disorders have been categorized in various ways in
differentsleepdisorderclassicationsystems.TheInternational
ClassicationofSleepDisorders,2ndEdition(ICSD-2)isused
as the basis for insomnia classication in this guideline. The
ICSD-2identiesinsomniaasoneofeightmajorcategoriesof
sleepdisordersand,withinthis group,liststwelve specicin-
somniadisorders(Table3).
ICSD-2delineatesbothgeneraldiagnosticcriteriathatapply
toallinsomniadisorders,aswellasmorespeciccriteriafor
each diagnosis. Insomnia complaints may also occur in asso-
ciation with comorbid disorders or other sleep disorder catego-
ries, such as sleep related breathing disorders, circadian rhythm
sleep disorders, and sleep related movement disorders.
Epidemiology
Insomnia occurs in individuals of all ages and races, and has
been observed across all cultures and countries.8,9 The actual
prevalence of insomnia varies according to the stringency of the
denitionused.Insomniasymptomsoccurinapproximately33%
to 50% of the adult population; insomnia symptoms with dis-
tressorimpairment(i.e.,generalinsomniadisorder)in10%to
15%;and specic insomniadisorders in 5% to 10%.10 Consis-
tent risk factors for insomnia include increasing age, female sex,
comorbid(medical,psychiatric,sleep,andsubstanceuse)disor-
ders, shift work, and possibly unemployment and lower socio-
economic status. Patients with comorbid medical and psychiatric
conditions are at particularly increased risk, with psychiatric and
chronicpain disordershavinginsomnia ratesashighas 50%to
75%.11-13Theriskrelationshipbetweeninsomniaandpsychiatric
disorders appears to be bidirectional; several studies have also
veys, and frequent teleconference discussions, the expert panel
identiedconsensusareasandrecommendationsforthoseareas
notcoveredbyAASMpracticeparameters.Recommendations
weregeneratedbypanelmembersanddiscussedbyall.Tomin-
imize individual expert bias, the group anonymously voted and
ratedconsensusrecommendationsfrom1:stronglydisagreeto
9:stronglyagree.Consensuswasdenedwhenallexpertsrated
arecommendation 8 or 9. If consensus was not evident after
therstvote, the consensus recommendations were discussed
again, amended as appropriate, and a second anonymous vote
was conducted. If consensus was not evident after the second
vote, the process was repeated until consensus was attained to
include or exclude a recommendation.
Use of Practice Parameters and Clinical Guidelines
AASM practice parameter papers are based on evidence-
based review and grading of literature, often addressing a spe-
cicissueortopic.Clinicalguidelinesprovideclinicianswitha
working overview for disease or disorder evaluation and man-
agement. These guidelines include practice parameter papers
and also include areas with limited evidence in order to provide
acomprehensivepractice guideline. Both practice parameters
andclinicalguidelinesdeneprinciplesofpracticethatshould
meettheneedsofmostpatients.Theyshouldnot,however,be
considered exhaustive, inclusive of all available methods of
care, or exclusive of other methods of care reasonably expected
to obtain the same results. The ultimate judgment regarding
appropriateness of any specic therapy must be made by the
clinician and patient in light of the individual circumstances
presented by the patient, available diagnostic tools, accessible
Table 1—AASMLevelsofRecommendations
Term Denition
Standard Thisisagenerallyacceptedpatient-carestrategythatreectsahighdegreeofclinicalcertainty.Thetermstandardgenerally
impliestheuseofLevel1Evidence,whichdirectlyaddressestheclinicalissue,oroverwhelmingLevel2Evidence.
Guideline Thisis a patient-carestrategythatreects a moderatedegreeof clinical certainty.Thetermguidelineimplies the useof
Level2EvidenceoraconsensusofLevel3Evidence.
Option Thisisapatient-carestrategythatreectsuncertainclinicaluse.Thetermoptionimpliesinsufcient,inconclusive,orcon-
ictingevidenceorconictingexpertopinion.
S Schutte-Rodin, L Broch, D Buysse et al

Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 491
demonstrated an increased risk of psychiatric disorders among
individuals with prior insomnia.13Thecourseofinsomniaisof-
tenchronic,withstudiesshowingpersistencein50%to85%of
individuals over follow-up intervals of one to several years.14
DIAGNOSIS OF CHRONIC INSOMNIA
Evaluation
Theevaluation of chronicinsomnia is enhancedby under-
standing models for the evolution of chronic insomnia.15-18
Numerous models may be reasonable from neurobiological,
neurophysiological,cognitive, behavioral(andother) perspec-
tives. Although details of current models are beyond the scope
of this practice guideline, general model concepts are critical
for identifying biopsychosocial predisposing factors (such as
hyperarousal, increased sleep-reactivity, or increased stress
response),precipitating factors, and perpetuating factorssuch
as(1)conditionedphysicalandmentalarousaland(2)learned
negative sleep behaviors and cognitive distortions. In particu-
lar,identication of perpetuating negative behaviors and cog-
nitive processes often provides the clinician with invaluable
information for diagnosis as well as for treatment strategies.
In contrast to evolving models and diagnostic classications
for insomnia, procedures for clinical evaluation have remained
relatively stable over time. Evaluation continues to rest on a
careful patient history and examination that addresses sleep and
wakingfunction(Table4),aswellascommonmedical,psychi-
atric, and medication/substance-related comorbidities (Tables
5,6,and7).Theinsomniahistoryincludesevaluationof:
I. The Primary Complaint: Patients with insomnia may
complainofdifcultyfallingasleep,frequentawakenings,dif-
cultyreturningtosleep,awakeningtooearlyinthemorning,
or sleep that does not feel restful, refreshing, or restorative. Al-
though patients may complain of only one type of symptom, it
is common for multiple types of symptoms to co-occur, and for
thespecicpresentationtovaryovertime.Keycomponentsin-
cludecharacterizationofthecomplainttype,duration(months,
years,lifetime),frequency(nightsperweekornumberoftimes
pernight),severityofnighttimedistressandassociateddaytime
symptomatology,course(progressive,intermittent,relentless),
factors which increase or decrease symptoms, and identica-
tion of past and current precipitants, perpetuating factors, treat-
ments, and responses.
Evaluation and Management of Chronic Insomnia in Adults
ICSD-2 Sleep Disorder Categories:
Insomnias
Sleep Related Breathing Disorders
Hypersomnias of Central Origin
Circadian Rhythm Disorders
Parasomnias
Sleep Related Movement Disorders
Isolated Symptoms
Other Sleep Disorders
Insomnias (specific disorders)
Adjustment (Acute) Insomnia
Behavioral Insomnia of Childhood
Psychophysiological Insomnia
Paradoxical Insomnia
Idiopathic Insomnia
Inadequate Sleep Hygiene
Insomnia Due to Mental Disorder
Insomnia Due to Medical Condition
Insomnia Due to Drug or Substance
Insomnia Not Due to Substance or Known
Physiological Condition, Unspecified
Physiological (Organic) Insomnia, Unspecified
Table 3—ICSD-2InsomniaDiagnoses
Table 4—SleepHistory
Primary insomnia complaint:
 CharacterizationofComplaint(s):
 • Difcultyfallingasleep
 • Awakenings
 • Poororunrefreshingsleep
Onset
 Duration
Frequency
 Severity
 Course
Perpetuating factors
Past and current treatments and responses
Pre-Sleep Conditions:
Pre-bedtime activities
 Bedroomenvironment
 Eveningphysicalandmentalstatus
Sleep-Wake Schedule (average, variability):
 Bedtime:
 Timetofallasleep
 • Factorsprolongingsleeponset
 • Factorsshorteningsleep
Awakenings
 • number,characterization,duration;
 • associatedsymptoms
 • associatedbehaviors
 FinalawakeningversusTimeoutofbed
Amount of sleep obtained
Nocturnal Symptoms:
Respiratory
 Motor
Other medical
 Behavioralandpsychological
Daytime Activities and Function:
Identify sleepiness versus fatigue
Napping
 Work
 Lifestyle
 Travel
 Daytimeconsequences(seeICSD-2Criteria-Table2)
 • QualityofLife
 • Mooddisturbance
 • Cognitivedysfunction
 • Exacerbationofcomorbidconditions

Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 492
Table 5—Common Comorbid Medical Disorders, Conditions,
andSymptoms
System Examples of disorders, conditions, and
symptoms
Neurological Stroke,dementia,Parkinsondisease,seizure
disorders, headache disorders, traumatic
brain injury, peripheral neuropathy, chronic
pain disorders, neuromuscular disorders
Cardiovascular Angina,congestiveheartfailure,dyspnea,
dysrhythmias
Pulmonary COPD,emphysema,asthma,laryngospasm
Digestive Reux,pepticulcerdisease,cholelithiasis,
colitis, irritable bowel syndrome
Genitourinary Incontinence,benignprostatichypertrophy,
nocturia, enuresis, interstitial cystitis
Endocrine Hypothyroidism,hyperthyroidism,diabetes
mellitus
Musculoskeletal Rheumatoidarthritis,osteoarthritis,
bromyalgia,Sjögrensyndrome,kyphosis
Reproductive Pregnancy, menopause, menstrual cycle
variations
Sleepdisorders Obstructivesleepapnea,centralsleep
apnea, restless legs syndrome, periodic limb
movement disorder, circadian rhythm sleep
disorders, parasomnias
Other Allergies, rhinitis, sinusitis, bruxism,
alcohol and other substance use/dependence/
withdrawal
Table 6—CommonComorbidPsychiatricDisordersandSymptoms
Category Examples
Mooddisorders Majordepressivedisorder,bipolarmooddisorder,dysthymia
Anxietydisorders Generalizedanxietydisorder,panicdisorder,posttraumaticstressdisorder,
obsessive compulsive disorder
Psychoticdisorders Schizophrenia,schizoaffectivedisorder
Amnestic disorders Alzheimer disease, other dementias
Disordersusuallyseeninchildhoodandadolescence Attentiondecitdisorder
Other disorders and symptoms Adjustment disorders, personality disorders, bereavement, stress
timetofallasleep(sleeplatency),numberofawakenings,wake
timeaftersleeponset(WASO),sleepduration,andnappingcan
bequantiedretrospectivelyduringtheclinicalassessmentand
prospectivelywithsleep-wakelogs.Althoughnospecicquan-
titative sleep parameters dene insomnia disorder, common
complaints for insomnia patients are an average sleep latency
>30 minutes, wake after sleep onset >30 minutes, sleep ef-
ciency<85%,and/ortotalsleeptime<6.5hours.19,20Day-to-day
variability should be considered, as well as variability during
longer periodicities such as those that may occur with the men-
strual cycle or seasons. Patterns of sleep at unusual times may
assistinidentifyingCircadianRhythmDisorders such asAd-
vancedSleepPhaseTypeorDelayedSleepPhaseType.Assess-
ingwhetherthenalawakeningoccursspontaneously orwith
an alarm adds insight into the patient’s sleep needs and natural
sleep and wake rhythm. Finally, the clinician must ascertain
whether the individual’s sleep and daytime complaints occur
despite adequate time available for sleep, in order to distinguish
insomniafrombehaviorallyinducedinsufcientsleep.
IV. Nocturnal Symptoms: Patient and bed partner reports
may also help to identify nocturnal signs, symptoms and behav-
iorsassociatedwithbreathing-relatedsleepdisorders(snoring,
gasping, coughing), sleep related movement disorders (kick-
ing,restlessness),parasomnias(behaviorsorvocalization),and
comorbidmedical/neurological disorders (reux, palpitations,
seizures, headaches). Other physical sensations and emotions
associatedwithwakefulness (such as pain, restlessness,anxi-
ety,frustration,sadness)maycontributetoinsomniaandshould
also be evaluated.
V. Daytime Activities and Daytime Function: Daytime
activities and behaviors may provide clues to potential causes
and consequences of insomnia. Napping (frequency/day,
times, voluntary/involuntary), work (work times, work type
such as driving or with dangerous consequences, disabled,
caretakerresponsibilities), lifestyle (sedentary/active, home-
bound, light exposure, exercise), travel (especially across
timezones),daytimedysfunction(qualityoflife,mood,cog-
nitivedysfunction), and exacerbationof comorbid disorders
shouldbeevaluatedindepth.Commondaytimeconsequences
include:
• Fatigue and sleepiness. Feelings of fatigue (low energy,
physical tiredness, weariness) are more common than
symptomsofsleepiness(actualtendencytofallasleep)in
patientswithchronicinsomnia.Thepresenceofsignicant
sleepiness should prompt a search for other potential sleep
disorders.Thenumber,duration,andtimingofnapsshould
be thoroughly investigated, as both a consequence of in-
somnia and a potential contributing factor.
II. Pre-Sleep Conditions: Patients with insomnia may de-
velop behaviors that have the unintended consequence of per-
petuating their sleep problem. These behaviors may begin as
strategies to combat the sleep problem, such as spending more
timeinbedinaneffortto“catchup”onsleep.Otherbehaviors
in bed or in the bedroom that are incompatible with sleep may
include talking on the telephone, watching television, computer
use,exercising, eating, smoking,or“clockwatching.”Insom-
nia patients may report sensations of being more aware of the
environment than are other individuals and may report antici-
pating a poor sleep hours before bedtime, and become more
alert and anxious as bedtime approaches. Characterization of
the sleeping environment (couch/bed, light/dark, quiet/noisy,
roomtemperature,alone/bedpartner,TVon/off)aswellasthe
patient’sstateofmind(sleepyvs.wideawake,relaxedvs.anx-
ious)ishelpfulinunderstandingwhichfactorsmightfacilitate
or prolong sleep onset or awakenings after sleep.
III. Sleep-Wake Schedule: In evaluating sleep-related
symptoms, the clinician must consider not only the patient’s
“usual”symptoms,butalsotheirrange,day-to-dayvariability,
andevolutionovertime.Specicsleep-wakevariablessuchas
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Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 493
insomnia.Likewise,thedirect effects of over-the-counterand
prescription medications and substances (Table 7), and their
effects upon withdrawal, may impact both sleep and daytime
symptoms.Conditions oftencomorbidwithinsomnia, such as
mood and anxiety disorders, may also have familial or genetic
components.Socialandoccupationalhistoriesmayindicatenot
only the effects of insomnia on the individual, but also possible
contributing factors. Occupational assessment should speci-
cally include work around dangerous machinery, driving duties,
regular or irregular shift-work and transmeridian travel.
Physical and Mental Status Examination: Chronic in-
somnia is not associated with any specic features on physi-
calor mental status examination. However,these examsmay
provide important information regarding comorbid conditions
anddifferentialdiagnosis.Aphysicalexamshouldspecically
evaluate risk factors for sleep apnea (obesity,increased neck
circumference,upper airwayrestrictions)and comorbidmedi-
cal conditions that include but are not limited to disorders of
pulmonary, cardiac, rheumatologic, neurological, endocrine
(suchasthyroid),andgastrointestinalsystems.Thementalsta-
tus exam should focus on mood, anxiety, memory, concentra-
tion, and degree of alertness or sleepiness.
Supporting Information: Whileathoroughclinicalhistory
and exam form the core of the evaluation, differential diagno-
sis is further aided by the use of sleep logs, questionnaires for
sleep quality, sleepiness, psychological assessment and quality
oflife(Table8),andinsomecases,actigraphy.21-23Forspecic
insomnias, psychological testing, quality of life questionnaires,
andother comorbid questionnairesandtestingare useful.The
choice of assessment tools should be based on the patient’s pre-
sentation and the clinician’s expertise. At minimum, the patient
shouldcomplete:
(1)A general medical/psychiatric/medication questionnaire
(toidentifycomorbiddisordersandmedicationuse)
(2)TheEpworthSleepinessScaleorothersleepinessassess-
ment(toidentifysleepypatients)24
(3)Atwo-weeksleeplogtoidentifysleep-waketimes,gen-
eral patterns, and day-to-day variability.
When possible, questionnaires and a two-week sleep log
shouldbecompletedpriortotherstvisittobegintheprocess
• Mood disturbances and cognitive difculties.Complaints
of irritability, loss of interest, mild depression and anxi-
ety are common among insomnia patients. Patients with
chronic insomnia often complain of mental inefciency,
difculty remembering, difculty focusing attention, and
difcultywithcomplexmentaltasks.
• Quality of life:Theirritabilityandfatigueassociatedwith
insomniamaycauseinterpersonaldifcultiesforinsomnia
patients, or avoidance of such activities. Conversely, in-
terpersonaldifcultiesmaybeanimportantcontributorto
insomniaproblemsforsomeindividuals. Sleep and wak-
ing problems may lead to restriction of daytime activities,
includingsocialevents,exercise,orwork.Lackofregular
daytime activities and exercise may in turn contribute to
insomnia.
• Exacerbation of comorbid conditions. Comorbid condi-
tions may cause or increase sleep difculties. Likewise,
poor sleep may exacerbate symptomatology of comorbid
conditions.Sleepcomplaintsmayheraldtheonsetofmood
disorders or exacerbation of comorbid conditions.
VI. Other History: A complete insomnia history also in-
cludes medical, psychiatric, medication/substance, and family/
social/occupationalhistories.Awide range of medical (Table
5)andpsychiatric(Table6) conditions can be comorbid with
Evaluation and Management of Chronic Insomnia in Adults
Table 7—CommonContributingMedicationsandSubstances
Category Examples
Antidepressants SSRIs (uoxetine, paroxetine, sertraline,
citalopram, escitalopram, uvoxamine),
venlafaxine, duloxetine, monoamine oxi-
dase inhibitors
Stimulants Caffeine, methylphenidate, amphetamine
derivatives, ephedrine and derivatives, co-
caine
Decongestants Pseudoephedrine, phenylephrine, phenyl-
propanolamine
Narcotic analgesics Oxycodone, codeine, propoxyphene
Cardiovascular β-Blockers, α-receptor agonists and an-
tagonists, diuretics, lipid-lowering agents
Pulmonary Theophylline,albuterol
Alcohol
Table 8—ExamplesofInsomniaQuestionnairesUsedinBaselineandTreatmentOutcomeAssessment
Questionnaire Description
EpworthSleepinessScale ESSisan8-itemselfreportquestionnaireusedtoassesssubjectivesleepiness(scorerange:
0-24;normal<10).
InsomniaSeverityIndex ISIisa7-itemratingusedtoassessthepatient’sperceptionofinsomnia.
PittsburghSleepQualityIndex PSQIisa24-itemselfreportmeasureofsleepquality(poorsleep:globalscore>5).
BeckDepressionInventory BDI(orBDI-II)isa21-itemselfreportinventoryusedtomeasuredepression(minimalorno
depression:BDI<10;moderatetosevere:BDI>18).
State-TraitAnxietyInventory- STAIisa20-itemselfreportinventoryusedtomeasureanxiety(scorerange:20-80;
FormYTraitScale minimumanxiety:T-score<50;signicantanxiety:Tscore>70).
FatigueSeverityScale FSSisa9-itempatientratingofdaytimefatigue.
ShortFormHealthSurvey(SF-36) SF-36isa36-itemselfreportinventorythatgenericallymeasuresqualityoflifeforanydis-
order(rangefrom0(poorest)to100(well-being).
DysfunctionalBeliefsandAttitudes DBASisaself-ratingof28statementsthatisusedtoassessnegativecognitionsaboutsleep.
aboutSleepQuestionnaire

Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 494
patients with chronic insomnia have daytime impairment of
cognition, mood, or performance that impacts on the patient
and potentially on family, friends, coworkers and caretakers.
Chronicinsomnia patients aremorelikelyto use healthcare
resources, visit physicians, be absent or late for work, make
errors or have accidents at work, and have more serious road
accidents.25,26 Increased risk for suicide, substance use relapse,
and possible immune dysfunction have been reported.27 Co-
morbid conditions, particularly depression, anxiety, and sub-
stance use, are common. There is a bidirectional increased
risk between insomnia and depression. Other medical condi-
tions, unhealthy lifestyles, smoking, alcoholism, and caffeine
dependencearealsorisksforinsomnia.Selfmedicationwith
alcohol, over-the-counter medications, prescription medica-
tions, and melatonin account for millions of dollars annual-
ly. 28Cliniciansshouldbealerttothesepossibleindividualand
societal risks during the evaluation.
Genetics: With the exception of fatal familial insomnia, a
raredisorder,nospecicgeneticassociationshavebeenidenti-
edfor insomnia.Afamilialtendency for insomniahas been
observed, but the relative contributions of genetic trait vulner-
ability and learned maladaptive behaviors are unknown.
General Considerations and Treatment Goals
It is essential to recognize and treat comorbid conditions
(e.g., major depression or medical disorder such as chronic
pain)thatcommonlyoccurwithinsomnia.29Likewise,identi-
cationandmodicationofinappropriatecaffeine,alcohol,and
self-medicationarenecessary.Timingoradjustmentsofcurrent
medications require consideration and may provide symptom
relief. For example, changing to a less stimulating antidepres-
sant or changing the timing of a medication may improve sleep
or daytime symptoms.
Goalsofinsomniatreatment(Table10)includereductionof
sleep and waking symptoms, improvement of daytime function,
andreductionofdistress.Treatmentoutcomecanbemonitored
longitudinally with clinical evaluation, questionnaires, and
sleep logs.
Before consideration of treatment choices, the patient and
physician should discuss primary and secondary treatment goals
based on the primary complaint and baseline measures such as
sleep latency,number of awakenings, WASO, frequency and
severityofthecomplaint(s),nighttimedistress,andrelatedday-
timesymptoms (Table10).Afterdiscussing treatment options
tailoredtoaddresstheprimarycomplaint,aspecicfollow-up
plan and time frame should be outlined with the patient, regard-
less of the treatment choice.
Quantifying sleep quality, daytimefunction, and improve-
ment in comorbid conditions requires more involved assess-
ment,oftenusingspecicquestionnairesforspecicinsomnia
problems(Table8).Iftheclinicianisunfamiliarwiththesetests,
administration and monitoring of these measures may require
referral to a behavioral sleep medicine specialist, psychologist,
or other testing professional, as clinically appropriate.
Psychological and behavioral interventions and benzodiaz-
epinereceptoragonists(BzRAs)havedemonstratedshort-term
efcacyfor the treatmentof chronic insomnia.Psychological
andbehavioralinterventionsshowshortandlongtermefcacy
of the patient viewing global sleep patterns, in contrast with one
specicnight,andtoenlistthepatientintakingan activerole
in treatment. Primary baseline measures obtained from a sleep
loginclude:
• Bedtime
• Sleeplatency(SL:timetofallasleepfollowingbedtime)
• Numberofawakeningsanddurationofeachawakening
• Wake after sleep onset (WASO: the sum of wake times
fromsleeponsettothenalawakening)
• Timeinbed(TIB:timefrombedtimetogettingoutofbed)
• Totalsleep time (TST: time in bed minus SL and minus
WASO)
• Sleepefciency percent (SE equals TST divided by TIB
times100)
• Naptimes(frequency,times,durations)
Sleeplogsmayalsoincludereportsofsleepquality,daytime
impairment, medications, caffeine, and alcohol consumption
foreach24-hourperiod.
Objective Assessment Tools: Laboratorytesting,polysom-
nography and actigraphy are not routinely indicated in the eval-
uation of insomnia, but may be appropriate in individuals who
presentwithspecicsymptomsorsignsofcomorbid medical
or sleep disorders.
Differential Diagnosis
Theinsomniaandinsomnia-relateddisorderslistedinICSD-2
canbeconsideredconceptuallyinthreemajorgroupings:
 Insomnia associated with other sleep disorders most com-
monlyincludessleeprelatedbreathingdisorders(e.g.,ob-
structivesleep apnea), movement disorders (e.g., restless
legsorperiodiclimbmovementsduringsleep)orcircadian
rhythmsleepdisorders;
 Insomnia due to medical or psychiatric disorders or to
drug/substance(comorbidinsomnia);and
 Primary insomnias including psychophysiological, idio-
pathic, and paradoxical insomnias.
Table9describesthekey featuresofICSD-2 insomniadis-
orders.Figure1presentsadiagnosticalgorithmforchronicin-
somniabasedonthefeaturesdescribedinTable9.Itshouldbe
noted that comorbid insomnias and multiple insomnia diagno-
ses may coexist and require separate identication and treat-
ment.
TREATMENT OF CHRONIC INSOMNIA
Indications for Treatment
Treatmentis recommended when the chronic insomnia has
a signicant negative impact on the patient’s sleep quality,
health, comorbid conditions, or daytime function. It is essential
to recognize and treat comorbid conditions that commonly oc-
cur with insomnia, and to identify and modify behaviors and
medications or substances that impair sleep.
Risk Counseling
Public Health Burden and Public Safety: Insomnia
causes both individual and societal burdens. By denition,
S Schutte-Rodin, L Broch, D Buysse et al

Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 495
develop and become key perpetuating factors that can be targeted
withpsychologicalandbehavioraltherapies.Treatmentswhich
address these core components play an important role in the man-
agement of both primary and comorbid insomnias.29Thesetreat-
ments are effective for adults of all ages, including older adults.
Whilemostefcacy studies have focused on primary insomnia
patients, more recent data demonstrate comparable outcomes in
patients with comorbid psychiatric or medical insomnia.
The etiology of insomnia is typically multifactorial. In co-
morbid insomnias, treatment begins by addressing the comorbid
condition.This may includetreatmentofmajordepressivedis-
order, optimal management of pain or other medical conditions,
elimination of activating medications or dopaminergic therapy
for movement disorder. In the past, it was widely assumed that
treatment of these comorbid disorders would eliminate the in-
somnia.However,ithasbecomeincreasinglyapparentthatover
the course of these disorders, numerous psychological and be-
havioral factors develop which perpetuate the insomnia problem.
These perpetuating factors commonly include worry about in-
and can be used for treatment of both primary and comorbid in-
somnias. Psychological and behavioral interventions and phar-
macological interventions may be used alone or in combination
(Figure2). Regardless of treatment choice, frequent outcome
assessment and patient feedback is an important component of
treatment. In addition, periodic clinical reassessment following
completion of treatment is recommended as the relapse rate for
chronic insomnia is high.
Psychological and Behavioral Therapies
Currentmodelssuggestthatphysiologicaland cognitive hy-
perarousal contribute to the evolution and chronicity of insom-
nia. In addition, patients typically develop problematic behaviors
such as remaining in bed awake for long periods of time, often
resulting in increased efforts to sleep, heightened frustration and
anxiety about not sleeping, further wakefulness and negative
expectations, and distorted beliefs and attitudes concerning the
disorder and its consequences. Negative learned responses may
Evaluation and Management of Chronic Insomnia in Adults
Figure 1—AlgorithmfortheEvaluationofChronicInsomnia.Whenusingthisdiagram,theclinicianshouldbeawarethatthepresenceofone
diagnosis does not exclude other diagnoses in the same or another tier, as multiple diagnoses may coexist. Acute Adjustment Insomnia, not a
chronic insomnia, is included in the chronic insomnia algorithm in order to highlight that the clinician should be aware that extrinsic stressors
may trigger, perpetuate, or exacerbate the chronic insomnia.
No
No
Consider Behaviorally
Induced Insufficient Sleep
Consider Short Sleeper
Yes
Consider Other/
Unspecified Insomnia; Re-
evaluate for other occult or
comorbid disorders
Abnormal pattern
of sleep-wake
timing
Medications,
substances
temporally related
to insomnia
-Restless Legs
symptoms
-Snoring , breathing
symptoms
-Abnormal sleep
movements
-Daytime sleepiness
Psychiatric
disorder
temporally related
to insomnia
Medical disorder
temporally related
to insomnia
Yes No Yes No NoYes Yes No Yes No
Consider Circadian Rhythm
Sleep Disorder
Consider Insomnia due to
Mental Disorder
Consider Insomnia due to
Medical Condition
Consider Insomnia due to
Drug, Substance, or
Alcohol
Consider Restless Legs Syndrome ,
Periodic Limb Movement Disorder ,
Sleep Related Breathing Disorder ,
Parasomnias
Marked subjective-
objective
mismatch, extreme
sleep symptoms
Behaviors and
practices
incompatible with
good sleep
Presence of acute
environmental,
physical, or social
stress
Conditioned
arousal, learned
sleep-preventing
associations
Childhood onset,
no precipitant
Yes No Yes No NoYes Yes No Yes No
Consider Paradoxical
Insomnia
Consider Inadequate Sleep
Hygiene
Consider Adjustment
Insomnia
Consider
Psychophysiological
Insomnia
Consider Idiopathic
Insomnia
Complaint of difficulty falling sleep , difficulty
maintaining sleep, nonrestorative sleep
Adequate opportunity and circumstances for
sleep
Waking symptom s: Fatigue/ lethargy; conc entration/
attent ion; memory; mood; psyc homotor; physic al
Insomnia
Disorder
Comorbid
Insomnia
Disorders
Primary
Insomnia
Disorders
*Ass ess each
category*
*Assess each
category*

Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 496
thepatient’ssenseofself-efcacywithrespecttomanagement
ofinsomnia.Theseobjectivesareaccomplishedby:
I. Identifying the maladaptive behaviors and cognitions that
perpetuatechronicinsomnia;
II.Bringingthecognitivedistortionsinherentinthiscondi-
tion to the patient’s attention and working with the patient to re-
structure these cognitions into more sleep-compatible thoughts
andattitudes;
III.Utilizingspecicbehavioralapproachesthatextinguish
the association between efforts to sleep and increased arousal
by minimizing the amount of time spent in bed awake, while
ability to sleep and the daytime consequences of poor sleep, dis-
torted beliefs and attitudes about the origins and meaning of the
insomnia, maladaptive efforts to accommodate to the condition
(e.g., schedule or lifestyle changes), and excessive time spent
awakeinbed.Thelatterbehaviorisofparticularsignicancein
thatit oftenis associatedwith“tryinghard”tofallasleepand
growingfrustrationandtensioninthefaceofwakefulness.Thus,
the bed becomes associated with a state of waking arousal as this
conditioning paradigm repeats itself night after night.
An implicit objective of psychological and behavioral thera-
py is a change in belief system that results in an enhancement of
Table 9—ICSD-2Insomnias
Disorder Description
Adjustment(Acute)Insomnia Theessentialfeatureofthisdisorderisthepresenceofinsomniainassociationwithaniden-
tiable stressor, such as psychosocial, physical, or environmental disturbances.The sleep
disturbancehasarelativelyshortduration(days-weeks)andisexpectedtoresolvewhenthe
stressor resolves.
PsychophysiologicalInsomnia Theessentialfeaturesofthis disorderareheightenedarousalandlearnedsleep-preventingas-
sociations. Arousal may be physiological, cognitive, or emotional, and characterized by muscle
tension,“racingthoughts,”orheightenedawarenessoftheenvironment.Individualstypically
haveincreasedconcernaboutsleepdifcultiesandtheirconsequences,leadingto a“vicious
cycle”ofarousal,poorsleep,andfrustration.
ParadoxicalInsomnia Theessentialfeatureofthisdisorderisacomplaintofsevereornearly“total”insomniathat
greatly exceeds objective evidence of sleep disturbance and is not commensurate with the re-
porteddegreeofdaytimedecit.Althoughparadoxicalinsomniaisbestdiagnosedwithcon-
currentPSG and self-reports,itcan be presumptivelydiagnosedon clinical groundsalone.
Tosome extent, “misperception” of the severity of sleep disturbance may characterize all
insomnia disorders.
IdiopathicInsomnia Theessentialfeatureofthisdisorderisapersistentcomplaintofinsomniawithinsidiouson-
set during infancy or early childhood and no or few extended periods of sustained remission.
Idiopathicinsomniaisnotassociatedwithspecicprecipitatingorperpetuatingfactors.
InsomniaDuetoMentalDisorder Theessential feature of thisdisorderisthe occurrence of insomniathatoccursexclusively
duringthecourseofamentaldisorder,andisjudgedtobecausedbythatdisorder.Theinsom-
niaisofsufcientseveritytocausedistressortorequireseparatetreatment.Thisdiagnosisis
not used to explain insomnia that has a course independent of the associated mental disorder,
asis not routinely made in individualswiththe“usual” severity of sleep symptoms foran
associated mental disorder.
InadequateSleepHygiene Theessentialfeatureofthisdisorderisinsomniaassociatedwithvoluntarysleeppracticesor
activitiesthatareinconsistentwithgoodsleepqualityanddaytimealertness.Thesepractices
and activities typically produce increased arousal or directly interfere with sleep, and may
include irregular sleep scheduling, use of alcohol, caffeine, or nicotine, or engaging in non-
sleepbehaviorsinthesleepenvironment.Someelementofpoorsleephygienemaycharacter-
ize individuals with other insomnia disorders.
InsomniaDuetoaDrugorSubstance Theessentialfeatureofthisdisorderissleepdisruptionduetouseofaprescriptionmedica-
tion, recreational drug, caffeine, alcohol, food, or environmental toxin. Insomnia may occur
duringperiodsofuse/exposure, orduringdiscontinuation.Whentheidentiedsubstance is
stopped, and after discontinuation effects subside, the insomnia is expected to resolve or sub-
stantially improve.
InsomniaDuetoMedicalCondition Theessential feature of this disorder isinsomnia caused by a coexisting medical disorder
or other physiological factor. Although insomnia is commonly associated with many medi-
cal conditions, this diagnosis should be used when the insomnia causes marked distress or
warrantsseparateclinicalattention.Thisdiagnosisisnotusedtoexplaininsomniathathasa
course independent of the associated medical disorder, and is not routinely made in individu-
alswiththe“usual”severityofsleepsymptomsforanassociatedmedicaldisorder.
InsomniaNotDuetoSubstanceorKnown Thesetwodiagnosesareusedforinsomniadisordersthatcannotbeclassiedelsewherebut
PhysiologicCondition,Unspecied; aresuspectedtoberelatedtounderlyingmentaldisorders,psychologicalfactors,behaviors,
Physiologic(Organic)Insomnia, medicaldisorders,physiologicalstates,orsubstanceuseorexposure.Thesediagnosesare
Unspecied typicallyusedwhenfurtherevaluationisrequiredtoidentifyspecicassociatedconditions,
orwhenthepatientfailstomeetcriteriaforamorespecicdisorder.
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Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 497
Psychological and behavioral therapies for insomnia include
a number of different specic modalities (Table 11). Current
datasupport the efcacyofstimulus control, relaxation train-
ing, and cognitive behavioral therapy (CBT-1) (i.e.,multimodal
approaches that include both cognitive and behavioral ele-
ments)with or without relaxation therapy.Thesetreatmentsare
recommended as a standard of care for the treatment of chronic
simultaneously promoting the desired association of bed with
relaxationandsleep;
IV.Establishingaregularsleep-wakeschedule,healthysleep
habitsandanenvironmentconducivetogoodsleep;and
V. Employingotherpsychologicalandbehavioraltechniques
that diminish general psychophysiological arousal and anxiety
about sleep.
Figure 2—AlgorithmfortheTreatmentofChronicInsomnia
Insomnia Disorder
Insomnia comorbid with
other sleep disorder
“Primary”
insomnias
Insomnia comorbid with
medical, psychiatric, drug
Optimize treatment
for other sleep
disorder
Improved Not
improved
Optimize treatment
for comorbid
disorder
Not
improved Improved
Evaluate insomnia treatment
options (cost, preference,
availability )
Psychological and
behavioral
treatment
Pharmacologic
treatment
Combined
treatment
Improved Not
improved
CBT
Other
behavioral
treatment 1
Consider switching to
other modality or
combined treatment
--------------------------------
Reconsider diagnosis
Re-evaluate especially
for occult or comorbid
disorders
Improved Not
improved
Other
behavioral
treatment 2
BzRA or
ramelteon
Not
improved Improved
Different
BzRA or
ramelteon
Not
improved Improved
Sedating
antidepressant
Not
improved Improved
BzRA + sedating
antidepressant
Ongoing follow-up
for efficacy, side
effects, optimal
duration/
discontinuation
Improved Not
improved
Follow- up with
periodic review of
efficacy , review of
tx principles
Not
improved Improved
Evaluation and Management of Chronic Insomnia in Adults

Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 498
time. Factors in selecting a pharmacological agent should be
directedby:(1)symptompattern;(2)treatmentgoals;(3)past
treatmentresponses;(4)patientpreference;(5) cost;(6)avail-
ability of other treatments; (7) comorbid conditions; (8) con-
traindications;(9)concurrentmedicationinteractions;and(10)
side effects. An additional goal of pharmacologic treatment is
to achieve a favorable balance between therapeutic effects and
potential side effects.
CurrentFDA-approvedpharmacologictreatmentsforinsom-
nia include several BzRAs and a melatonin receptor agonist
(Table 12). Specic BzRAs differ from each other primarily
in terms of pharmacokinetic properties, although some agents
are relatively more selective than others for specic gamma
amino-butyricacid(GABA)receptorsubtypes.Theshort-term
efcacyof BzRAs have beendemonstratedinalargenumber
of randomized controlled trials. A smaller number of controlled
trials demonstrate continued efcacy over longer periods of
time.PotentialadverseeffectsofBzRAsincluderesidualseda-
tion, memory and performance impairment, falls, undesired be-
haviors during sleep, somatic symptoms, and drug interactions.
A large number of other prescription medications are used off-
label to treat insomnia, including antidepressant and anti-ep-
ilepticdrugs.The efcacyandsafetyfortheexclusiveuseof
these drugs for the treatment of chronic insomnia is not well
documented. Many non-prescription drugs and naturopathic
agents are also used to treat insomnia, including antihistamines,
melatonin, and valerian. Evidence regarding the efcacy and
safety of these agents is limited.
The following recommendations primarily pertain to pa-
tients with diagnoses of Psychophysiological, Idiopathic, and
ParadoxicalInsomniainICSD-2, or the diagnosis of Primary
InsomniainDSM-IV.Whenpharmacotherapyisutilized,treat-
ment recommendations are presented in sequential order.
I. Short/intermediate-acting BzRAs or ramelteon:* Ex-
amples of short/intermediate-acting BzRAs include zaleplon,
zolpidem,eszopiclone,triazolam,andtemazepam.Nospecic
agent within this group is recommended as preferable to the
othersina general sense; each hasbeen shown to have posi-
tive effects on sleep latency, TST, and/or WASO in placebo-
controlled trials.32-37However,individualpatientsmayrespond
differentially to different medications within this class. Factors
including symptom pattern, past response, cost, and patient
preferenceshould be considered in selectinga specic agent.
For example, zaleplon and ramelteon have very short half-lives
and consequently are likely to reduce sleep latency but have
littleeffectonwakingaftersleeponset(WASO);theyarealso
unlikelytoresultinresidualsedation.Eszopicloneandtemaze-
pam have relatively longer half-lives, are more likely to im-
prove sleep maintenance, and are more likely to produce re-
sidual sedation, although such residual activity is still limited
toa minority of patients.Triazolamhas been associated with
rebound anxiety and as a result, is not considered a rst line
hypnotic.PatientswhoprefernottouseaDEA-scheduleddrug,
and patients with a history of substance use disorders may be
appropriate candidates for ramelteon, particularly if the com-
plaintisthatofsleepinitiationdifculty.
II. Alternative BzRAs or ramelteon: In the event that a pa-
tient does not respond well to the initial agent, a different agent
withinthesameclassisappropriate.Selectionofthealternative
insomnia. Although other modalities are common and useful
with proven effectiveness, the level of evidence is not as strong
for psychological and behavioral treatments including sleep re-
striction, paradoxical intention, or biofeedback.Simpleeduca-
tionregardingsleephygienealonedoesnothaveprovenef-
cacyforthetreatmentofchronicinsomnia.Inpractice,specic
psychological and behavioral therapies are most often combined
asamulti-modaltreatmentpackagereferredtoasCBT-I.CBT-I
may also include the use of light and dark exposure, tempera-
ture, and bedroom modications. Other nonpharmacological
therapies such as light therapy may help to establish or rein-
force a regular sleep-wake schedule with improvement of sleep
quality and timing. A growing data base also suggests longer-
termefcacyofpsychologicalandbehavioraltreatments.
Whenaninitialpsychological/behavioraltreatmenthasbeen
ineffective, other psychological/ behavioral therapies, combi-
nation CBT-I therapies, or combined treatment with pharma-
cologicaltherapy(seebelow)maybeapplied.Additionally,the
presence of occult comorbid disorders should be considered.
Psychologists and other clinicians with more general cogni-
tive-behavioral training may have varying degrees of experi-
ence in behavioral sleep treatment. Such treatment is ideally
deliveredbyaclinicianwhoisspecicallytrainedinthisarea
suchasa behavioral sleep medicine specialist. TheAmerican
AcademyofSleepMedicinehasestablishedastandardizedpro-
cessforCerticationinBehavioralSleepMedicine.30,31Howev-
er, this level of care may not be available to all patients. Also of
note,thetype of administration (individual versus group) and
treatmentschedule(suchaseveryonetotwoweeksforseveral
sessions)mayvarybetweenproviders.Giventhecurrentshort-
age of trained sleep therapists, on-site staff training and alterna-
tivemethodsoftreatmentandfollow-up(suchastelephonere-
viewofelectronically-transferredsleeplogsorquestionnaires),
although unvalidated, may offer temporary options for access
to treatment for this common and chronic disorder.
Pharmacological Therapies
Thegoalsofpharmacologictreatmentaresimilartothoseof
behavioraltherapies: toimprovesleep qualityandquantity,to
enhance associated daytime function, to reduce sleep latency
and wakefulness after sleep onset, and to increase total sleep
Table 10—TreatmentGoals
1. PrimaryGoals:
• Improvementinsleepqualityand/ortime.
• Improvementofinsomnia-relateddaytimeimpairmentssuch
asimprovementofenergy,attentionormemorydifculties,
cognitive dysfunction, fatigue, or somatic symptoms.
2. OtherGoals:
• Improvement in an insomnia symptom (SOL, WASO, #
awakenings)suchas:
o SOL<30minutesand/or
o WASO<30minutesand/or
o Decreasedfrequency of awakenings orothersleepcom-
plaints
o TST>6hoursand/orsleepefciency>80%to85%.
• Formation of a positive and clear association between the
bed and sleeping
• Improvementinsleeprelatedpsychologicaldistress
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Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 499
beconsidered.Examplesofthesedrugsincludetrazodone,mir-
tazapine, doxepin, amitriptyline, and trimipramine. Evidence
fortheirefcacywhenusedaloneisrelativelyweak38-42 and no
specicagentwithinthisgroupisrecommended aspreferable
to the others in this group. Factors such as treatment history,
coexisting conditions (e.g. major depressive disorder), spe-
cicsideeffectprole, cost,andpharmacokinetic prolemay
guidetheselectionofaspecicagent.Forexample,trazodone
has little or no anticholinergic activity relative to doxepin and
amitriptyline, and mirtazapine is associated with weight gain.
Note that low-dose sedating antidepressants do not constitute
adequate treatment of major depression for individuals with co-
morbidinsomnia.However,theefcacyoflow-dosetrazodone
as a sleep aid in conjunction with another full-dose antidepres-
drugshouldbebasedonthepatient’sresponsetotherst.For
instance,apatientwhocontinuestocomplainofWASOmight
beprescribedadrugwithalongerhalf-life;apatientwhocom-
plains of residual sedation might be prescribed a shorter-acting
drug.ThechoiceofaspecicBzRAmayincludelonger-acting
hypnotics, such as estazolam. Flurazepam is rarely prescribed
because of its extended half life. Benzodiazepines not spe-
cicallyapproved forinsomnia(e.g.,lorazepam, clonazepam)
might also be considered if the duration of action is appropriate
for the patient’s presentation or if the patient has a comorbid
conditionthatmightbenetfromthesedrugs.
III. Sedating low-dose antidepressant (AD): When ac-
companied with comorbid depression or in the case of other
treatment failures, sedating low-dose antidepressants may next
Table 11—CommonCognitiveandBehavioralTherapiesforChronicInsomnia
Stimulus control (Standard) is designed to extinguish the negative association between the bed and undesirable outcomes such as wakeful-
ness,frustration,andworry.Thesenegativestatesarefrequentlyconditionedinresponsetoeffortstosleepasaresultofprolongedperiodsof
timeinbedawake.Theobjectivesofstimuluscontroltherapyareforthepatienttoformapositiveandclearassociationbetweenthebedand
sleep and to establish a stable sleep-wake schedule.
Instructions:Gotobedonlywhensleepy;maintainaregularschedule;avoidnaps;usethebedonlyforsleep;ifunabletofallasleep(orback
tosleep)within20minutes,removeyourselffrombed—engageinrelaxingactivityuntildrowsythenreturntobed—repeatthisasnecessary.
Patients should be advised to leave the bed after they have perceived not to sleep within approximately20minutes,ratherthanactualclock-
watching which should be avoided.
Relaxation training (Standard) such as progressive muscle relaxation, guided imagery, or abdominal breathing, is designed to lower somatic
and cognitive arousal states which interfere with sleep. Relaxation training can be useful in patients displaying elevated levels of arousal and
isoftenutilizedwithCBT.
Instructions:Progressivemuscle relaxationtraininginvolvesmethodicaltensing andrelaxingdifferentmusclegroupsthroughoutthebody.
Specictechniquesarewidelyavailableinwrittenandaudioform.
Cognitive Behavioral Therapy for Insomnia or CBT-I (Standard) is a combination of cognitive therapy coupled with behavioral treatments
(e.g.,stimuluscontrol,sleeprestriction)withorwithoutrelaxationtherapy.Cognitivetherapyseekstochangethepatient’sovervaluedbeliefs
andunrealisticexpectationsaboutsleep.Cognitivetherapyusesapsychotherapeuticmethodtoreconstructcognitivepathwayswithpositive
andappropriateconceptsaboutsleepanditseffects.Commoncognitivedistortionsthatareidentiedandaddressedinthecourseoftreatment
include:“Ican’tsleepwithoutmedication,”“Ihaveachemicalimbalance,”“IfIcan’tsleepIshouldstayinbedandrest,”“Mylifewillbe
ruinedifIcan’tsleep.”
Multicomponent therapy [without cognitive therapy] (Guideline) utilizesvariouscombinationsofbehavioral(stimuluscontrol,relaxation,sleep
restriction)therapies,andsleephygieneeducation.Manytherapistsusesomeformofmultimodalapproachintreatingchronicinsomnia.
Sleep restriction (Guideline)initiallylimits the time in bed to the total sleep time, as derived from baseline sleep logs.Thisapproachis
intended to improve sleep continuity by using sleep restriction to enhance sleep drive. As sleep drive increases and the window of oppor-
tunityforsleepremainsrestrictedwithdaytimenappingprohibited,sleepbecomesmoreconsolidated.Whensleepcontinuitysubstantially
improves,timeinbedisgraduallyincreased,toprovidesufcientsleeptimeforthepatienttofeelrestedduringtheday,whilepreservingthe
newly acquired sleep consolidation. In addition, the approach is consistent with stimulus control goals in that it minimizes the amount of time
spent in bed awake helping to restore the association between bed and sleeping.
Instructions (Note, when using sleep restriction, patients should be monitored for and cautioned about possible sleepiness):
Maintainasleeploganddeterminethemeantotalsleeptime(TST)forthebaselineperiod(e.g.,1-2weeks)
Setbedtimeandwake-uptimestoapproximatethemeanTSTtoachievea>85%sleepefciency(TST/TIB×100%)over7days;thegoal
isforthetotaltimeinbed(TIB)(not<5hours)toapproximatetheTST.
Makeweeklyadjustments:1)forsleepefciency(TST/TIB×100%)>85%to90%over7days,TIBcanbeincreasedby15-20minutes;
2)forSE<80%,TIBcanbefurtherdecreasedby15-20minutes.
RepeatTIBadjustmentevery7days.
Paradoxical intention (Guideline) isaspeciccognitivetherapyinwhichthepatientistrainedtoconfrontthefearofstayingawakeandits
potentialeffects.Theobjectiveistoeliminateapatient’sanxietyaboutsleepperformance.
Biofeedback therapy (Guideline) trainsthepatienttocontrolsomephysiologicvariablethroughvisualorauditoryfeedback.Theobjective
is to reduce somatic arousal.
Sleep hygiene therapy (No recommendation) involves teaching patients about healthy lifestyle practices that improve sleep. It should be used
in conjunction with stimulus control, relaxation training, sleep restriction or cognitive therapy.
Instructions include, but are not limited to, keeping a regular schedule, having a healthy diet and regular daytime exercise, having a quiet sleep
environment,andavoidingnapping,caffeine,otherstimulants,nicotine,alcohol,excessiveuids,orstimulatingactivitiesbeforebedtime.
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Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 500
Table 12—PharmaceuticalTherapyOptions
Drug Dosage Form Recommended Dosage Indications/Specic Comments
Benzodiazepine Receptor Agonistic Modulators (Schedule IV Controlled Substances)
Non-benzodiazepines
cyclopyrrolones
eszopiclone 1,2,3mgtablets 2-3mghs
1mghsinelderlyordebilitated;max2mg
1mghsinseverehepaticimpairment;max
2mg
 Primarily used for sleep-onset and main-
tenanceinsomnia;
 Intermediate-acting;
 No short-term usage restriction
imidazopyridines
zolpidem
zolpidem(controlled
release)
5,10mgtablets
6.25,12.5mg
tablets
10mghs;max10mg
5mghsinelderly,debilitated,orhepatic
impairment
12.5mghs
6.25mghsinelderly,debilitated,orhepatic
impairment
 Primarily used for sleep-onset insomnia
 Short-tointermediate-acting
 Primarily used for sleep-onset and main-
tenanceinsomnia;
 Controlled release; swallow whole, not
divided, crushed or chewed
pyrazolopyrimidines
zaleplon 5,10mgcapsules 10mghs;max20mg
5mghsinelderly,debilitated,mildto
moderate hepatic impairment, or concomitant
cimetidine
 Primarily used for sleep onset insomnia
 Maintenanceinsomniaaslongas4hours
is available for further sleep
 Short-acting
Benzodiazepines
estazolam 1,2mgtablets 1-2mghs
0.5mghsinelderlyordebilitated  Short-tointermediate-acting
temazepam 7.5,15,30mg
capsules
15-30mghs
7.5mghsinelderlyordebilitated  Short-tointermediate-acting
triazolam 0.125,0.25mg
tablets
0.25mghs;max0.5mg
0.125mghsinelderlyordebilitated;max
0.25mg
 Short-acting
urazepam 15,30mgcapsules 15-30mghs
15mghsinelderlyordebilitated
 Long-acting
 Risk of residual daytime drowsiness
Melatonin Receptor Agonists (Non-Scheduled)
ramelteon 8mgtablet 8mghs  Primarily used for sleep-onset insomnia
 Short-acting
 No short-term usage restriction
Tablepartiallyconstructedfromindividualdrugprescribinginformationlabeling.
Seeproductlabelingforcompleteprescribinginformation.
TheFDArecentlyrecommendedthatawarningbeissuedregardingadverseeffectsassociatedwithBzRAhypnotics.Thesemedicationshave
been associated with reports of disruptive sleep related behaviors including sleepwalking, eating, driving, and sexual behavior. Patients should
be cautioned about the potential for these adverse effects, and about the importance of allowing appropriate sleep time, using only prescribed
dosesandavoidingthecombinationofBzRAhypnoticswithalcohol,othersedatives,andsleeprestriction.
Generalcommentsaboutsedatives/hypnotics:
• Administrationonanemptystomachisadvisedtomaximizeeffectiveness.
• Notrecommendedduringpregnancyornursing.
• Cautionisadvisedifsigns/symptomsofdepression,compromisedrespiratoryfunction(e.g.,asthma,COPD,sleepapnea),orhepaticheart
failure are present.
• Cautionanddownwarddosageadjustmentisadvisedintheelderly.
• Safety/effectivenessinpatients<18yearsnotestablished
• AdditiveeffectonpsychomotorperformancewithconcomitantCNSdepressantsand/oralcoholuse.
• Rapiddosedecreaseorabruptdiscontinuanceofbenzodiazepinescanproducewithdrawalsymptoms,includingreboundinsomnia,similar
to that of barbiturates and alcohol.
Certainantidepressants(amitriptyline,doxepin,mirtazapine,paroxetine,trazodone)areemployedinlowerthanantidepressanttherapeuticdos-
agesforthetreatmentofinsomnia.ThesemedicationsarenotFDAapprovedforinsomniaandtheirefcacyforthisindicationisnotwellestab-
lished.
OTCsleepmedicationscontainantihistaminesastheprimaryagent;efcacyfortreatmentofinsomniaisnotwellestablished,especiallyits
long-term use.
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Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 501
limited efcacy of these substances and possible interactions
with their comorbid conditions and concurrent medications.
Pharmacological Treatment Failure
Although medications can play a valuable role in the man-
agement of insomnia, a subset of chronic insomnia patients may
have limited or only transient improvement with medication. As
recommended,alternativetrialsorcombinationsmaybeuseful;
however, clinicians should note that if multiple medication tri-
als have proven ultimately ineffective, cognitive behavioral ap-
proaches should be pursued in lieu of or as an adjunct to further
pharmacological trials. Additionally, the diagnosis of comorbid
orotherinsomniasshould bereconsidered.Cautionisadvised
regarding polypharmacy, particularly in patients who have not
or will not pursue psychological and behavioral treatments.
Mode of Administration/Treatment
Frequency of administration of hypnotics depends on the
specic clinical presentation; empirical data support both
nightlyandintermittent(2-5timesperweek)administration.49-
51Manycliniciansrecommendschedulednon-nightlydosingat
bedtime as a means of preventing tolerance, dependence, and
abuse, although these complications may be less likely with
newer BzRAagents. Anal strategy sometimes employed in
clinicalpractice is true “as needed”dosing when the patients
awakensfromsleep.Thisstrategyhasnotbeencarefullyinves-
tigated, and is not generally recommended due to the potential
for carry-over sedation the next morning and the theoretical
potential for inducing conditioned arousals in anticipation of a
medication dose.
Durationoftreatmentalsodependsonspecicclinicalchar-
acteristicsandpatientpreferences.FDAclasslabelingforhyp-
notics prior to 2005 implicitly recommended short treatment
duration;since2005,hypnoticlabelingdoesnotaddressdura-
tion of treatment. Antidepressants and other drugs commonly
usedoff-labelfortreatmentofinsomniaalsocarry nospecic
restrictions with regard to duration of use. In clinical practice,
hypnotic medications are often used over durations of one to
twelve months without dosage escalation,52-55 but the empiri-
cal data base for long-term treatment remains small. Recent
randomized, controlled studies of non-BZD-BzRAs (such as
eszopicloneorzolpidem)havedemonstratedcontinuedefcacy
without signicant complications for 6 months, and in open-
labelextensionstudiesfor12monthsorlonger.
Formanypatients,an initialtreatmentperiodof 2-4 weeks
may be appropriate, followed by re-evaluation of the contin-
ued need for treatment. A subset of patients with severe chron-
ic insomnia may be appropriate candidates for longer-term or
chronicmaintenancetreatment,but,asstated,thespecicden-
ingcharacteristicsofthesepatientsareunknown.Thereislittle
empirical evidence available to guide decisions regarding which
drugs to use long-term, either alone or in combination with be-
havioraltreatments.Thus,guidelines for long-term pharmaco-
logical treatment need to be based primarily on common clinical
practice and consensus. If hypnotic medications are used long-
term, regular follow-up visits should be scheduled at least every
sixmonthsinordertomonitorefcacy,sideeffects,tolerance,
sant medication has been assessed in a number of studies of
patients with depressive disorders. These studies, of varying
qualityanddesign,suggestmoderateefcacyfortrazodonein
improving sleep quality and/or duration. It is unclear to what
extentthesendingscanbegeneralizedto otherpresentations
of insomnia.
IV. Combination of BzRA + AD: No research studies have
been conducted to specically examine such combinations,
but a wealth of clinical experience with the co-administration
ofthesedrugs suggests the general safety and efcacyofthis
combination. A combination of medications from two different
classesmayimproveefcacybytargetingmultiplesleep-wake
mechanisms while minimizing the toxicity that could occur
withhigherdosesofasingleagent.Sideeffectsarelikelytobe
minimizedfurtherbyusingthelowdosesofADtypicalinthe
treatment of insomnia, but potential daytime sedation should be
carefully monitored.
V. Other prescription drugs:Examplesincludegabapentin,
tiagabine,quetiapine,andolanzapine.Evidenceofefcacyfor
these drugs for the treatment of chronic primary insomnia is in-
sufcient.Avoidanceofoff-labeladministrationofthesedrugs
is warranted given the weak level of evidence supporting their
efcacyforinsomniawhenusedaloneandthepotentialforsig-
nicantsideeffects(e.g.,seizureswithtiagabine;neurological
side effects, weight gain, and dysmetabolism with quetiapine
andolanzapine).
VI. Prescription drugs- Not recommended: Although
chloralhydrate, barbiturates, and“non-barbituratenon-benzo-
diazepine”drugs(suchasmeprobamate)areFDA-approvedfor
insomnia, they are not recommended for the treatment of in-
somnia,giventheirsignicantadverseeffects,lowtherapeutic
index, and likelihood of tolerance and dependence.
VII. Over-the-counter agents: Antihistamines and antihis-
tamine-analgesic combinations are widely used self-remedies
for insomnia. Evidence for their efcacy and safety is very
limited,withveryfewavailablestudiesfromthepast10years
using contemporary study designs and outcomes.43 Antihista-
mines have the potential for serious side effects arising from
their concurrent anticholinergic properties. Alcohol, likely the
most common insomnia self-treatment, is not recommended be-
cause of its short duration of action, adverse effects on sleep,
exacerbation of obstructive sleep apnea, and potential for abuse
anddependence.Veryfewherbaloralternativetreatmentshave
been systematically evaluated for the treatment of insomnia. Of
these, the greatest amount of evidence is available regarding
valerian extracts and melatonin.44-47 Available evidence sug-
gests that valerian has small but consistent effects on sleep la-
tency, with inconsistent effects on sleep continuity, sleep dura-
tion,andsleeparchitecture.Melatoninhasbeentestedinalarge
numberofclinicaltrials.Meta-analyseshavedemonstratedthat
melatonin has small effects on sleep latency, with little effect
onWASOorTST.Itshouldbenotedthatsomeofthepublished
trialsofmelatoninhaveevaluateditsefcacyasachronobiotic
(phase-shiftingagent)ratherthanasahypnotic.
Long-termuseofnon-prescription (over-the-counter) treat-
mentsisnotrecommended.Efcacyandsafetydataformost
over-the-counter insomnia medications is limited to short-term
studies;their safetyandefcacyin long-termtreatmentisun-
known.48 Patients should be educated regarding the risks and
Evaluation and Management of Chronic Insomnia in Adults

Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 502
thelongertermwithoutsignicantcomplications.Thesefacts,
however, do not provide the clinician with a clear set of practice
standards, particularly when it comes to sequencing or combi-
nationof therapies. The literaturethathasexaminedtheissue
of individual pharmacotherapy or cognitive behavioral treat-
ment versus a combination of these approaches demonstrates
that short-term pharmacological treatments alone are effective
during the course of treatment for chronic insomnia but do not
provide sustained improvement following discontinuation,65,66
whereas cognitive behavioral treatments produce signicant
improvement of chronic insomnia in the short-term, and these
improvements appear sustained at follow-up for up to two
years.67Studiesofcombinedtreatmentshowmixedandincon-
clusiveresults. Takenasa whole, theseinvestigations do not
demonstrate a clear advantage for combined treatment over
cognitive behavioral treatment alone.65,66,68-70
DISCLOSURE STATEMENT
This was not an industry supported study. Dr. Buysse has
consulted to and/or been on the advisory board of Actelion,
Arena,Cephalon, Eli Lilly,GlaxoSmithKline, Merck, Neuro-
crine,Neurogen,Pzer,Respironics,Sano-Aventis,Sepracor,
Servier,SomnusTherapeutics,StressEraser,Takeda,andTran-
sceptPharmaceuticals.The otherauthorshaveindicatedno-
nancialconictsofinterest.
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and abuse/misuse of medications. Periodic attempts to reduce
the frequency and dose in order to minimize side effects and
determine the lowest effective dose may be indicated.
On discontinuation of hypnotic medication after more than a
fewdays’use,reboundinsomnia (worseningofsymptoms with
dosereduction,typicallylasting1-3days),potentialphysicalas
well as psychological withdrawal effects, and recurrence of in-
somnia may all occur.56 Rebound insomnia and withdrawal can
be minimized by gradually tapering both the dose and frequency
of administration.57 In general, the dose should be lowered by the
smallest increment possible in successive steps of at least several
days’duration.Taperingthefrequencyofadministration(suchas
everyotheroreverythirdnight)hasalsobeenshowntominimize
reboundeffects.Successfultaperingmay require severalweeks
to months. As noted elsewhere, tapering and discontinuation of
hypnotic medication is facilitated by concurrent application of
cognitive-behavioral therapies, which increase rates of success-
ful discontinuation and duration of abstinence.58,59
Pharmacotherapy for Specific Populations
Theguidelinespresentedaregenerallyappropriateforolder
adults as well as younger adults. However,lower doses of all
agents (with the exception of ramelteon) may be required in
older adults, and the potential for side-effects and drug-drug
interactions should be carefully considered.60-62 The above
guidelines are likely to be appropriate for older adolescents as
well, but very little empirical data is available to support any
exclusivetreatment approachinthis agegroup.The treatment
of insomnia comorbid with depression or anxiety disorders
shouldfollowthesamegeneraloutlinepresentedabove.How-
ever, concurrent treatment with an antidepressant medication
atrecommendeddoses,oranefcaciouspsychotherapyforthe
comorbidcondition,isrequired.BothBzRAsandlow-dosese-
datingADshavebeenevaluatedas adjunctive agents to other
full-dose antidepressants for treatment of comorbid insomnia in
patients with depression.63,64 If a sedating antidepressant drug
is used as monotherapy for a patient with comorbid depres-
sion and insomnia, the dose should be that recommended for
treatment of depression. In many cases, this dose will be higher
thanthe typical doseusedtotreat insomnia alone.Quetiapine
orolanzapinemaybespecicallyusefulinindividualswithbi-
polar disorder or severe anxiety disorders. In a similar fashion,
treatment of insomnia comorbid with a chronic pain disorder
should follow the general treatment outline presented above. In
some cases, medications such as gabapentin or pregabalin may
beappropriatelyusedatanearlierstage.Concurrenttreatment
with a longer-acting analgesic medication near bedtime may
also be useful, although narcotic analgesics may disrupt sleep
continuity in some patients. Furthermore, patients with comor-
bid insomnia may benet from behavioral and psychological
treatments or combined therapies, in addition to treatment of
the associated condition.
Combined Therapy for Insomnia
Hypnoticmedicationsareefcaciousasshort-termtreatment
for insomnia, and more recent evidence suggests that benzodi-
azepineand BzRAhypnoticsmaymaintaineffectivenessover
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