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The Efficacy and Safety of Drug Treatments for Chronic Insomnia in Adults: A Meta-analysis of RCTs
Open accessAbstract
Background Hypnotics have a role in the management of acute insomnia; however, the efficacy and safety of pharmacological interventions in the management of chronic insomnia is unclear.Objective The objective of this paper is to conduct a systematic review of the efficacy and safety of drug treatments for chronic insomnia in adults.Data sources Twenty-one electronic databases were searched, up to July 2006.Study selection Randomized double-blind, placebo-controlled trials were eligible. Quality was assessed using the Jadad scale. Data were pooled using the random effects model.Data synthesis One hundred and five studies were included in the review. Sleep onset latency, as measured by polysomnography, was significantly decreased for benzodiazepines (BDZ), (weighted mean difference: -10.0 minutes; 95% CI: -16.6, -3.4), non-benzodiazepines (non-BDZ) (-12.8 minutes; 95% CI: -16.9, -8.8) and antidepressants (ADP) (-7.0 minutes; 95% CI: -10.7, -3.3). Sleep onset latency assessed by sleep diaries was also improved (BDZ: -19.6 minutes; 95% CI: -23.9, -15.3; non-BDZ: -17.0 minutes; 95% CI: -20.0, -14.0; ADP: -12.2 minutes; 95% CI: -22.3, -2.2). Indirect comparisons between drug categories suggest BDZ and non-BDZ have a similar effect. All drug groups had a statistically significant higher risk of harm compared to placebo (BDZ: risk difference [RD]: 0.15; non-BDZ RD: 0.07; and ADP RD: 0.09), although the most commonly reported adverse events were minor. Indirect comparisons suggest that non-BDZ are safer than BDZ.Conclusions Benzodiazepines and non-benzodiazepines are effective treatments in the management of chronic insomnia, although they pose a risk of harm. There is also some evidence that antidepressants are effective and that they pose a risk of harm.
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“BZDs are effective in the treatment of anxiety disorders [2,3,4] and insomnia [5,6].”
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“Because the FDA requires manufacturers to report adverse as well as favorable clinical trial outcomes, the FDA NDA documents for these four hypnotics may offer a less-biased presentation than might review of the published literature, where publication bias is serious (Buscemi et al., 2007; Glass et al., 2005).”
BackgroundAssociations of Benzodiazepine With Adverse Prognosis in Heart Failure Patients With Insomnia
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“Hypnotics such as zolpidem, eszcopliclone, and zaleplon also have demonstrated efficacy for insomnia but are associated with adverse effects that include residual daytime effects (Buscemi et al., 2007) and drug dependency (Schuckit, Smith, Kramer, Danko, & Volpe, 2002).”
BackgroundEvaluation of subjective efficacy and safety of ramelteon in Japanese subjects with chronic insomnia
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“Nevertheless, while these ‘‘newer’’ agents have similar efficacy as benzodiazepines, they may be associated with less next-day sedation and have a lower risk of dependence [5,6].”
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“Although medication is effective in the short term, it has negative side effects and significant risks (Buscemi et al., 2007).”
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“…(NbN): positive allosteric modulators (GABA-A receptor, benzodiazepine site)) are a treatment for anxiety disorders (Baldwin et al., 2014; Katzman et al., 2014) and insomnia (Buscemi et al., 2007; Wilson et al., 2019) but are no longer considered the first-line treatment for either indication.”
BackgroundKorean Clinical Practice Guideline for the Diagnosis and Treatment of Insomnia in Adults
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“on a meta-analysis of randomized controlled trials (Buscemi et al., 2007).”
MethodDays-Out-of-Role Associated With Insomnia and Comorbid Conditions in the America Insomnia Survey
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“Although numerous controlled studies have documented the effectiveness of pharmacologic (79) and behavioral (80) treatments of insomnia, the functional outcomes in those studies generally involved specific functions—such as daytime fatigue, cognitive and motor impairment, or mood—rather than days-out-of-role (81– 83).”
Zolpidem-Associated Consequences
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“5 was chosen because a recent meta-analysis on common sleep aids reported effect sizes in the medium to large range (Buscemi et al., 2007).”
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“Only eszopiclone, zolpidem CR, and ramelteon are approved for treatment of chronic insomnia.(34)”
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Management of insomnia: update and new approaches
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“The latest meta-analysis included 52 studies on BZ hypnotics and 48 studies on Z-drugs with primarily nonelderly subjects and both genders, but once again no between-drug differences were found to be significant.(39) The polysomnographically measured sleep onset latency was significantly reduced in the treatment with…”
Delphi consensus recommendations for the management of chronic insomnia in Canada
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Sleep Quality and Insomnia Severity among Italian University Students: A Latent Profile Analysis
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A novel forehead temperature-regulating device for insomnia: a randomized clinical trial
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“Despite utilization evidence that non-benzodiazepine hypnotics, which serve as benzodiazepine receptor agonists (BzRAs), are preferred over benzodiazepines for the treatment of insomnia [1,2], evidence of greater efficacy or safety is very limited [3–5].”
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Systematic Review of Hypnotherapy for Sleep and Sleep Disturbance
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“Potentially low rates of side effects may make hypnotherapy for sleep a far more preferable treatment than sleep medications, which often have numerous side effects and concerns of dependence (Buscemi et al., 2007).”
BackgroundMethodThe use of hypnosedative drugs in a university hospital: has anything changed in 10 years?
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“This finding can be a significant advantage of dietary supplements relative to other conventional hypnotic medications, which often show reduced effects or tolerance after long-term use [53].”
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Anderson, G. D., Elmer, G. W., Buchanan, D. T., Vitiello, M. V., Kantor, E. D., Kalhorn, T. F., Howald, W. N., Barsness, S. M., & Landis, C. A. (2010) · Phytotherapy Research · doi:10.1002/ptr.3151 · Cited by 20
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“Zolpidem (an imidazopyridine) and zopiclone (a cyclopyrrolone) have both been shown to be effective in reducing sleep onset latency, and increasing sleep efficiency in insomniacs [105].”
BackgroundClinical Sleep–Wake Disorders II: Focus on Insomnia and Circadian Rhythm Sleep Disorders
Spiegelhalder, K., Nissen, C., & Riemann, D. W. (2017) · Handbook of experimental pharmacology · doi:10.1007/164_2017_40 · Cited by 20
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Neurofeedback for insomnia: Current state of research
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Meta-Analysis: Melatonin for the Treatment of Primary Sleep Disorders
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“While pharmacological options for insomnia (Buscemi et al., 2007) and nightmares (Kung, Espinel, & Lapid, 2012) have been identified, caution is advised due to the toxicity of some medications such as benzodiazepine (Buckley, Dawson, Whyte, & O’Connell, 1995) and their potential to be used in…”
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“That meta-analysis even questioned whether the “z” hyp-notics significantly increased objective total sleep time 33 .”
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“Although effective, these medications often cause side effects such as residual daytime sedation, drowsiness, dizziness, lightheadedness, cognitive impairment, motor incoordination, and dependence [5].”
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“Pharmacotherapies, in particular sedative-hypnotic medications, also significantly reduce subjective (e.g., self-report measures) and objective (e.g., polysomnography, actigraphy) insomnia symptoms (Buscemi et al., 2007; Huedo-Medina, Kirsch, Middlemass, Klonizakis, & Siriwardena, 2012).”
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“Further, the efficacy and safety of sleep medications have not been sufficiently established (Buscemi et al., 2007).”
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Medication management in older adults
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Critical appraisal of ramelteon in the treatment of insomnia
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Benzodiazepine Use Among Older Adults
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Effectiveness and Safety of Moxibustion for Poststroke Insomnia
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“for novel therapeutic options[8] Dual orexin receptor antagonists (DORAs), which act as competitive inhibitors of orexin A and orexin B, can promote sleep and mitigate insomnia by selectively binding to orexin receptors 1 and 2.”
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Metadata
- Authors
- Buscemi, N., Vandermeer, B., Friesen, C., Bialy, L., Tubman, M., Ospina, M., Klassen, T. P., & Witmans, M.
- Affiliations
- University of Alberta (CA)
- Corresponding author
- Bialy, Liza
- Venue
- Journal of General Internal Medicine
- Published
- 2007-07-10
- Volume
- 22
- Issue
- 9
- Pages
- 1335-1350
- ISSN
- 0884-8734 (ISSN-L)
- 1525-1497
- PMC
- PMC2219774
- OpenAlex
- W2002669039
- Cited by
- 448
- References
- 39
- Citations by year
- 2026: 8 · 2025: 17 · 2024: 18 · 2023: 19 · 2022: 32 · 2021: 23 · 2020: 39 · 2019: 28 · 2018: 29 · 2017: 30 · 2016: 34 · 2015: 27 · 2014: 28 · 2013: 23 · 2012: 25
- FWCI
- 2.64
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Journal of General Internal Medicine (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Department of Health and Human Services
- National Institutes of Health
- Agency for Healthcare Research and Quality
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Health Sciences › Medicine › Physiology (medical) › Obstructive Sleep Apnea Research
- Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
- Keywords
- chronic insomnia, hypnotics, benzodiazepines, non-benzodiazepine hypnotics, antidepressants, sleep latency, drug efficacy, drug safety, adverse events, adults
- MeSH terms
- Adult, Aged, Antidepressive Agents, Benzodiazepines, Female, Humans, Hypnotics and Sedatives, Sleep Initiation and Maintenance Disorders, Male, Middle Aged, Randomized Controlled Trials as Topic, Polysomnography
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