Focus of This Summary
This is a summary of a systematic review that evaluated current evidence regarding the effectiveness, comparative effectiveness, and adverse effects of management strategies for insomnia disorder in adults. The systematic review synthesized evidence from 169 randomized controlled trials and 12 observational studies published through January 2015. This summary is provided to assist in informed clinical decisionmaking. However, reviews of evidence should not be construed to represent clinical recommendations or guidelines.
Insomnia involves dissatisfaction with sleep quantity or quality and is associated with difficulty initiating sleep, maintaining sleep, returning to sleep after early morning waking, or a combination thereof. Diagnostic criteria for insomnia disorder require that sleep symptoms cause clinically significant distress or impairment in functioning, occur despite adequate opportunity for sleep, and are experienced on a chronic basis (at least 3 nights per week for at least 3 months).1
Many treatments are available for insomnia symptoms, including sleep hygiene education, behavioral and psychological interventions, prescription medications, over-the-counter medications and supplements, and complementary and alternative medicine (CAM) treatments.
Psychological and behavioral interventions include cognitive behavioral therapy for insomnia (CBT-I), brief or multicomponent behavioral therapy, stimulus control, relaxation training, and sleep restriction (Appendix). Guidelines2,3 recommend CBT-I as first-line treatment for all adults with chronic insomnia disorder.
The U.S. Food and Drug Administration (FDA) has approved several prescription drugs for insomnia, typically for short-term use. These include nonbenzodiazepine hypnotics (zaleplon, zolpidem, eszopiclone), an orexin receptor antagonist (suvorexant), a melatonin agonist (ramelteon), some benzodiazepines (e.g., triazolam, temazepam), and an antidepressant (doxepin).
The systematic review assessed the efficacy, comparative effectiveness, and adverse effects of a broad range of management strategies for insomnia disorder in adults.
Psychological and Behavioral Therapy: Effectiveness (Table 1)
- CBT-I improved global and sleep outcomes in the general adult population (low to moderate strength of evidence [SOE]). Effectiveness was demonstrated across modes of delivery and was sustained in the long term (at least 6 months) for some outcomes (low to moderate SOE).
- CBT-I also appeared to improve global and some sleep outcomes in older adults and in patients with pain conditions and insomnia (low SOE for most outcomes).
Psychological and Behavioral Therapy: Adverse Effects
Evidence was insufficient regarding the adverse effects of psychological and behavioral interventions.
Pharmacological Therapy: Effectiveness (Table 2)
- Nonbenzodiazepine hypnotics (eszopiclone and zolpidem) and an orexin receptor antagonist (suvorexant) improved some outcomes among the general adult population in primarily short-term (up to 3 months) studies (low to moderate SOE).
- The antidepressant doxepin improved global and some sleep outcomes, primarily in older patients (low to moderate SOE).
- Evidence regarding the long-term efficacy of pharmacological therapies for insomnia disorder is very limited.
Pharmacological Therapy: Adverse Effects (Table 3)
- Evidence regarding the long-term (more than 3 months) safety of pharmacological therapies for insomnia disorder is limited. Nevertheless, observational studies suggest a possible association between hypnotics and fractures, head injuries, dementia, and cancer.
- FDA labels warn of several potential severe adverse effects for all insomnia medications.
Overview of Clinical Research Evidence
The effects of insomnia treatment can be assessed in various ways. Outcome measures include:
- Sleep outcome measures: These assess specific sleep parameters (sleep-onset latency, time awake after sleep onset, total sleep time, and sleep efficiency) or sleep quality.
- Global outcome measures: These assess improvements in both sleep and accompanying daytime dysfunction or distress (e.g., fatigue or sleepiness, depressed mood, reduced quality of life). The Insomnia Severity Index (ISI) and the Pittsburgh Sleep Quality Index (PSQI) are common global outcome instruments.
Strength of Evidence Scale†
High: [evidence high]
High confidence that the evidence reflects the true effect. Further research is very unlikely to change our confidence in the estimate of effect.
Moderate: [evidence medium]
Moderate confidence that the evidence reflects the true effect. Further research may change our confidence in the estimate of effect and may change the estimate.
Low: [evidence low]
Low confidence that the evidence reflects the true effect. Further research is likely to change our confidence in the estimate of effect and is likely to change the estimate.
Evidence is either unavailable or does not permit a conclusion.
†The overall evidence grade was assessed based on the ratings for the following domains: study limitations, directness, consistency, precision, and reporting bias. Other domains were considered, as appropriate: dose-response association, plausible confounding, and strength of association (i.e., magnitude of effect). For additional details on the methodology used to assess strength of evidence, please refer to: Owens DK, Lohr KN, Atkins D, et al. AHRQ series paper 5: grading the strength of a body of evidence when comparing medical interventions—Agency for Healthcare Research and Quality and the Effective Health-Care Program. J Clin Epidemiol. 2010 May;63(5):513-23. PMID: 19595577.
- Observational studies of long-term harms of pharmacological agents showed possible increased risks of the following:
- Hypnotics in general: dementia, cancer
- Zolpidem: head injury or fracture requiring hospitalization, hip fracture, cancer
- Ramelteon: prolactinoma
- Temazepam: death, cancer
- In observational studies, the effects of hypnotics on mortality were mixed.
Gaps in Knowledge and Other Issues
- Evidence regarding the effects of insomnia interventions in most patient subgroups was limited. Participants in general adult population trials were predominantly middle-aged, healthy, female, and white.
- Reporting on quality of life and functioning was very limited.
- Evidence for comparative effectiveness evaluations was low or insufficient.
- Evidence was insufficient regarding the effectiveness of most single behavioral interventions, such as sleep hygiene education, relaxation techniques, and sleep restriction.
- Evidence was insufficient regarding the adverse effects of psychological and behavioral interventions. Some studies reported participant withdrawals, which may reflect feasibility issues (e.g., treatments are time-consuming) rather than physical or psychological harms.
- Studies of pharmacological interventions rarely lasted more than 6 weeks. Evidence regarding their longer-term efficacy and safety is limited or lacking.
- Outcome reporting and intervention effect sizes varied among studies of pharmacological therapy, and a large placebo response was observed in some studies.
- Evidence was insufficient to assess the efficacy or comparative effectiveness of CAM interventions.
Key Points for Clinician and Patient and Caregiver Discussions
- CBT-I appears to be effective and safe as treatment for insomnia disorder.
- Guidelines from professional organizations such as the American College of Physicians and the American Academy of Sleep Medicine recommend CBT-I as the first-line treatment for all adults with chronic insomnia disorder.
- Web-based CBT-I may be an option for individuals without access to a therapist trained in CBT-I techniques.
- Additional resources for CBT-I information include the American Academy of Sleep Medicine and the National Sleep Foundation.
- A list of specialists certified by the American Board of Sleep Medicine in behavioral sleep medicine (including CBT-I) is available on its Web site.
- Some medications appear to be effective for insomnia in the short term (e.g., up to 3 months), but they have numerous potential side effects, some of which are serious.
- In light of the limited evidence regarding long-term benefits and the potential for serious adverse effects, medications should be used for insomnia disorder with caution.
The information in this summary comes from 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.
This summary was prepared by the John M. Eisenberg Center for Clinical Decisions and Communications Science at Baylor College of Medicine, Houston, TX. It was written by M. Denise Daley, M.D., Geetha Achanta, Ph.D., Philip Alapat, M.D., Frank Domino, M.D., Austin De La Cruz, Pharm.D., and Michael Fordis, M.D.
1American Psychiatric Association. Sleep-wake disorders. In: Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Publishing; 2013:chapter 15.
2Qaseem A, Kansagara D, Forciea MA, et al. Ann Intern Med. 2016 Jul 19;165(2):125-33. PMID: 27136449.
3Morgenthaler T, Kramer M, Alessi C, et al. Sleep. 2006 Nov;29(11)1415-9. PMID: 17162987.
|Table adapted from: Morgenthaler T, Kramer M, Alessi C, et al.; American Academy of Sleep Medicine. Practice parameters for the psychological and behavioral treatment of insomnia: an update. An American Academy of Sleep Medicine report. Sleep. 2006 Nov;29(11):1415-9. PMID: 17162987; and Buysse DJ. Insomnia. JAMA. 2013 Feb 20;309(7):706-16. PMID: 23423416.|
|Sleep Hygiene Education||Education of patients about health and environmental factors to improve sleep (e.g., avoiding/ limiting caffeine, nicotine, and alcohol; maintaining a regular sleep schedule; avoiding napping; exercising regularly; maintaining a quiet and dark bedroom).|
|Stimulus Control||Therapy to change behaviors associated with bed or the bedroom and to establish consistent sleep patterns (e.g., using the bedroom for sleep only; going to bed only when tired).|
|Sleep Restriction||Interventions to limit time in bed to sleep time and to gradually increase time in bed as sleep efficiency improves.|
|Relaxation Training||Training to reduce somatic tension and to control bedtime thoughts that impair sleep.|
|Brief Behavioral Therapy (BBT)||Therapy that combines stimulus control and sleep restriction strategies.|
|Multicomponent Behavioral Therapy (MBT)||Therapy combining various behavioral interventions but not cognitive therapy.|
|Cognitive Therapy||Interventions to change patients' thinking about sleep by identifying, challenging, and replacing dysfunctional beliefs and attitudes (e.g., challenging notions about requisite amounts of sleep and about how sleep is out of their control; thought journaling).|
|Cognitive Behavioral Therapy for Insomnia (CBT-I)||Multimodal combination of treatments, including cognitive therapy, behavioral interventions (sleep restriction, stimulus control, or both), and education (sleep hygiene).|