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 definition)
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 specific 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 identification 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
defined as the subjective perception of difficulty 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 specific 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 specific 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 efficiency, 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 insufficient 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 specific
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 benefit
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 efficacy 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 specific disorder. In this guide-
line, an insomnia disorder is defined as a subjective report of
difficulty 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 specific 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 modified 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 specific
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 scientific literature (for specific 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 scientific 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 reflect 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 modified 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 diffi culty initiating sleep, diffi culty maintain-A complaint of difficulty initiating sleep, difficulty maintain-
ing sleep, or waking up too early, or sleep that is chronically
nonrestorative or poor in quality.
B. The above sleep difficulty 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 difficulty 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 reflects
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 specific disorder. In this guideline, an
insomnia disorder is defined as a subjective report of difficulty
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 classification systems. The International
Classification of Sleep Disorders, 2nd Edition (ICSD-2) is used
as the basis for insomnia classification in this guideline. The
ICSD-2 identifies insomnia as one of eight major categories of
sleep disorders and, within this group, lists twelve specific in-
somnia disorders (Table 3).
ICSD-2 delineates both general diagnostic criteria that apply
to all insomnia disorders, as well as more specific 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
definition 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 specific 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 com