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Management of Insomnia Disorder

Comparative Effectiveness Reviews, No. 159

, PhD, MSPH, MLIS, , MS, , MPH, , MD, MS, , MPH, , MD, MPH, , PhD, , MD, , , PhD, , MD, and , MD, MPH.

Author Information and Affiliations
Rockville (MD): Agency for Healthcare Research and Quality (US); .
Report No.: 15(16)-EHC027-EF

Structured Abstract


To assess the efficacy, comparative effectiveness, and harms of treatments for insomnia disorder in the general adult population and older adults.

Data sources:

Ovid MEDLINE®, the Cochrane Central Register of Controlled Trials, Embase®, and PsycINFO® bibliographic databases; hand searches of references of relevant studies.

Review methods:

Two investigators screened abstracts and full-text articles of identified references for eligibility. Eligible studies included systematic reviews, randomized controlled trials (RCTs), and long-term observational pharmacologic studies enrolling participants with insomnia disorder. We analyzed data for global outcomes (measures that assess both sleep and daytime functioning associated with sleep), sleep parameters, and harms. We assessed risk of bias for RCTs, extracted data, assessed quality of relevant systematic reviews, and evaluated strength of evidence for comparisons and outcomes. Pooled estimates were analyzed to assess the efficacy and comparative effectiveness of treatments.


We searched bibliographic databases through January 2015 for studies evaluating psychological, pharmacologic, and complementary and alternative medicine interventions for insomnia disorder. We synthesized evidence from 181 unique studies (data from 128 unique RCTs and 3 systematic reviews that synthesize data from 42 unique RCTs) and 12 observational studies. Sample sizes and enrollment criteria varied; most trials were short in duration. Outcome reporting and intervention effect sizes varied, and a large placebo response was often observed. Cognitive behavioral therapy for insomnia (CBT-I) improved global outcomes and nearly all sleep parameters in the general adult population, older adults, and adults with pain. We found insufficient evidence on adverse effects of these interventions. Evidence was less robust for psychological interventions other than CBT-I, but low-strength evidence shows that some interventions improve some sleep outcomes. Low- to moderate-strength evidence indicated that the nonbenzodiazepine hypnotics eszopiclone and zolpidem, and the orexin receptor antagonist suvorexant, improved short-term global and sleep outcomes in general adult populations. Doxepin improved sleep outcomes. The absolute mean effect was small. Evidence for benzodiazepine hypnotics, melatonin agonists, and antidepressants in general populations and for most pharmacologic interventions in older adults was generally insufficient. Evidence on adverse effects from RCT data was generally insufficient or low strength. Observational studies suggest that hypnotics may be associated with dementia, fractures, and major injury. Food and Drug Administration (FDA) labels warn about cognitive and behavioral changes, including driving impairment, and other harms, and advise lower doses for females and older/debilitated adults. Evidence on complementary and alternative medicine was insufficient. Evidence was insufficient to compare hypnotic medications within or across classes or versus CBT-I.


CBT-I or medical therapy with eszopiclone, zolpidem, and suvorexant improve global and sleep outcomes for insomnia disorder. Clinical significance, applicability, comparative effectiveness, and long-term efficacy, especially among older adults, are less well known. Effect sizes vary, and a large placebo response is sometimes observed. Observational studies suggest an association of hypnotics with infrequent but serious harms. FDA labels provide specific warnings and precautions for drugs approved for insomnia.


Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1. Contract No. 290-2012-00016-I. Prepared by: Minnesota Evidence-based Practice Center, Minneapolis, MN

Suggested citation:

Brasure M, MacDonald R, Fuchs E, Olson CM, Carlyle M, Diem S, Koffel E, Khawaja IS, Ouellette J, Butler M, Kane RL, Wilt TJ. Management of Insomnia Disorder. Comparative Effectiveness Review No. 159. (Prepared by the Minnesota Evidence-based Practice Center under Contract No. 290-2012-00016-I). AHRQ Publication No.15(16)-EHC027-EF. Rockville, MD: Agency for Healthcare Research and Quality. December 2015. www.effectivehealthcare.ahrq.gov/reports/final.cfm.

This report is based on research conducted by the Minnesota Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2012-00016-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.

The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.

This report is made available to the public under the terms of a licensing agreement between the author and the Agency for Healthcare Research and Quality. This report may be used and reprinted without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of copyright holders.

AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied.

This report may periodically be assessed for the currency of conclusions. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at www.effectivehealthcare.ahrq.gov. Search on the title of the report.


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Bookshelf ID: NBK343503PMID: 26844312


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