New publications from AHRQ can help clinicians and patients effectively manage insomnia disorder, defined as a long-term condition in which a person has trouble sleeping at least three nights each week for at least three months. The clinical guide Management of Insomnia Disorder in Adults: Current State of the Evidence found evidence that cognitive behavioral therapy for insomnia can be effective and safe as a treatment. Some short-term studies found that medications were also effective for treating insomnia, but they have potential side effects. Also available is Managing Insomnia Disorder – A Review of the Research for Adults, a companion guide for patients to support treatment options discussions between clinicians, patients and caregivers.
Clinician Summary – Aug. 1, 2017
Management of Insomnia Disorder in Adults: Current State of the Evidence
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Table of Contents
- Focus of This Summary
- Background
- Conclusions
- Overview of Clinical Research Evidence
- Other Findings
- Gaps in Knowledge and Other Issues
- Key Points for Clinician and Patient and Caregiver Discussions
- Source
- References
- Appendix
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.
Background
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.
Conclusions
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.
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