The central feature of insomnia disorder is dissatisfaction with sleep quantity or quality, associated with difficulty falling asleep, maintaining sleep, or early morning awakening.¹ Insomnia disorder causes clinically significant distress or impairment in important areas of functioning. Sleep difficulties occur at least 3 nights per week for at least 3 months, and are not better explained by use of substances, medications, or by another disorder. Insomnia is diagnosed only when an individual has adequate opportunity for sleep; this distinguishes insomnia from sleep deprivation, which has different causes and consequences. Insomnia disorder is often comorbid with other sleep-wake, mental, or medical disorders that require separate management. Increased neural, physiological, and psychological arousal, together with perpetuating behavioral factors (such as excessive time in bed) are thought to underlie most cases of chronic insomnia. Acute insomnia, which meets all diagnostic criteria as chronic insomnia except in duration, may have different causes and specific treatment implications.

Individuals with insomnia disorder typically experience multiple sleep symptoms over time. Nevertheless, specific sleep symptoms may aid differential diagnosis. Difficulty falling asleep may signal delayed sleep phase syndrome, restless legs syndrome, or anxiety. Difficulty maintaining sleep can result from sleep apnea, nocturia, or pain. Early morning awakening is associated with advanced sleep phase syndrome and depression.

The diagnosis of insomnia relies on patient history from both the patient and bed partner. Self-report questionnaires and sleep diaries are often useful to assess insomnia severity, identify behaviors contributing to persistent insomnia, and monitor treatment effects. The Insomnia Severity Index² and Consensus Sleep Diary³ are examples of clinically practical, sensitive outcome measures. Both questionnaires can be completed quickly, within 2 to 3 minutes, at home or in the clinician’s office and provide useful self-report and behavioral information facilitating clinical management.

The American College of Physicians (ACP) recommends cognitive behavioral therapy for insomnia (CBT-I) as the initial treatment for chronic insomnia disorder.⁴ The ACP also recommends that clinicians and patients use a shared decision-making approach, including a discussion of the benefits, harms, and costs, to decide whether to use medications when CBT-I alone is unsuccessful.

CBT-I is a multimodal treatment that combines several behavioral and cognitive interventions. Specific components include education (eg, healthy sleep practices and expectations), stimulus control instructions, time-in-bed restriction, and relaxation training. CBT-I produces reliable, durable benefits in 70% to 80% of patients and may reduce the use of sedatives.⁵ CBT-I can be delivered by trained therapists and by self-guided, fully automated online programs (eg, SHUTi, Sleepio, and others). Overall CBT-I shows moderate to large effect sizes on outcomes of interest, including time to fall asleep, continuity, restfulness, and duration of sleep.⁵

Brief behavioral treatment for insomnia (BBTI),⁶ an evidence-based, easily administered approach derived from CBT-I, can also be used in a variety of treatment settings. BBTI is delivered in a single initial session with 2 to 3 brief follow-up visits in person or by telephone. BBTI includes 4 behavioral interventions that improve sleep consolidation by increasing sleep “drive,” reinforcing sleep regularity, reducing arousal, and increasing associations between bed and sleep: (1) reduce time in bed to match actual sleep duration, (2) get up at the same time every day, regardless of sleep duration, (3) do not go to bed unless sleepy, and (4) do not stay in bed unless asleep.

The patient’s progress should be monitored through daily sleep diaries and weekly telephone calls or electronic communications. As sleep becomes more consolidated, the patient can gradually increase time in bed to find the optimal balance between sleep continuity and sleep duration.

Pharmacological treatment is most appropriate for patients with acute insomnia (<3 months) and should be considered as an adjunct to cognitive behavioral treatment for patients with chronic insomnia disorder. The level of evidence for all drugs in the management of insomnia disorder is weak, with almost all studies rated as having a lower level of evidence because of industry sponsorship and other risks of bias related to issues such as small sample sizes, limited duration of follow-up, and limited clinical relevance (eg, comparison with placebo rather than an active pharmacologic or intervention). Changes in numerical indicators of efficacy (eg, changes in sleep latency) are consistent but not large.⁷

US Food and Drug Administration (FDA)–approved prescription medications for insomnia include benzodiazepines and benzodiazepine receptor agonists (BzRAs), the melatonin receptor agonist ramelteon, the tricyclic drug doxepin, and the orexin receptor antagonist suvorexant. Even though the margin of safety for benzodiazepines and BzRAs is relatively wide, adverse effects may include anterograde amnesia, complex sleep-related behaviors, falls, cognitive impairment, respiratory depression, and rebound insomnia. Agents with short elimination half-lives are preferred to longer-acting drugs to avoid daytime sedation. Intermittent dosing 3 to 4 times per week may reduce exposure and long-term use. Doxepin (3-6 mg) is appropriate for sleep maintenance insomnia and may be particularly helpful in patients with contraindications to benzodiazepine and BzRA drugs, such as substance use disorders. Suvorexant improves sleep maintenance insomnia symptoms with little evidence of tolerance and has a distinct mechanism of action. Ramelteon is most appropriate for sleep onset insomnia symptoms. Although antihistamines (eg, diphenhydramine, doxylamine) are FDA-approved for insomnia, evidence regarding their efficacy and safety is not robust.

A variety of other drugs commonly used to treat insomnia have not been rigorously evaluated for efficacy and safety and are not FDA-approved for this indication. These include low doses of sedating antidepressant drugs (eg, trazodone, mirtazapine). Sedating antipsychotic drugs (eg, olanzapine, quetiapine) are recommended only for patients with appropriate psychiatric diagnoses because of their potential metabolic, neurologic, and cardiovascular effects. Complementary and alternative agents, including melatonin and valerian, also lack sufficiently rigorous efficacy and safety data to recommend their use.

Published clinical practice guidelines suggest a pragmatic approach to the treatment of insomnia disorder,⁷ such as the steps presented in the Box, and also emphasize that the data supporting drug therapy are limited. Although the pragmatic approach suggests sequential steps, the clinician may modify the order to address a particular patient’s needs and preferences.

Insomnia disorder is frequently presented in general medical practice. Evaluation involves a careful history with the patient and bed partner, if available, and use of brief instruments to gauge severity and behaviors that destroy sleep. Use of cognitive behavioral therapy for insomnia is recommended as the first-line treatment. Pharmacotherapy of insomnia disorder, if used, should be on a short-term basis, and in shared decision making with the patient.

Corresponding Author: Charles F. Reynolds III, MD, University of Pittsburgh School of Medicine, 3811 O’Hara St, Pittsburgh, PA 15213 (reynoldscf@upmc.edu).

Published Online: October 23, 2017. doi:10.1001/jama.2017.15683

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Buysse reported receiving consulting fees from Bayer, BeHealth Solutions, CME Institute, Ebb Therapeutics, Merck, and Emmi Solutions. Dr Rush reported receiving consulting fees from Akili, American Psychiatric Association, Brain Resource Company, Compass, Curbstone Consultant, Eli Lilly, Emmes, Holmusk, LivaNova, Lundbeck A/S, MindLinc, Montana State University, National Institute on Drug Abuse, Santium, Sunovion, Taj Medical, Texas Tech, and Takeda USA; speaking fees from LivaNova, John Peter Smith Health Network, University of Montana, Montana State University, SingHealth, Stanford University, and Global Medical Education; and royalties from Guilford Press and the University of Texas Southwestern Medical Center. Dr Reynolds reported receiving pharmaceutical drug supplies for National Institutes of Health (NIH)–sponsored research studies from Bristol-Myers Squibb, Forest, Pfizer, and Lilly; grant funding from the National Institute of Mental Health, National Heart, Lung, and Blood Institute, Centers for Medicare & Medicaid Services, Patient-Centered Outcomes Research Institute, Brain and Behavior Research Foundation, Commonwealth of Pennsylvania, John A. Hartford Foundation, National Palliative Care Research Center, Clinical and Translational Science Institute, and American Foundation for Suicide Prevention; speaker fees from MedScape and WebMD; being co-inventor and receiving royalties from the psychometric analysis of the Pittsburgh Sleep Quality Index; and serving on the American Association for Geriatric Psychiatry editorial review board. As of 2016, Dr Reynolds assumed the role of editor-in-chief for the American Journal of Geriatric Psychiatry, for which he receives an honorarium.

Funding/Support: This work was supported by grants P60 MD000207, P30 MH090333, UL1RR024153, and UL1TR000005 from the NIH and the University of Pittsburgh Medical Center Endowment in Geriatric Psychiatry.

Role of the Funder/Sponsor: The funders had no role in the preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.