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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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Lindner, A. V., Novák, M., Bohra, M., & Mucsi, I. (2015) · Seminars in Nephrology · doi:10.1016/j.semnephrol.2015.06.007 · Cited by 68
The effects of sedative music on sleep quality of older community-dwelling adults in Singapore
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Use of sedative-hypnotics and the risk of Alzheimer’s dementia: A retrospective cohort study
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Prevention of internalizing disorders and suicide via adolescent sleep interventions
Blake, M. J., & Allen, N. B. (2019) · Current Opinion in Psychology · doi:10.1016/j.copsyc.2019.08.027 · Cited by 70
The Cost of Insomnia and the Benefit of Increased Access to Evidence-Based Treatment
Reynolds, S. A., & Ebben, M. R. (2017) · Sleep Medicine Clinics · doi:10.1016/j.jsmc.2016.10.011 · Cited by 70
“Of note, only 18 of the 105 studies analyzed had a duration greater than or equal to 30 days and only three studies were 12 weeks or longer.(26) Therefore, little is known about tolerance and the long-term effects of hypnotics.”
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Neuroscience-driven discovery and development of sleep therapeutics
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“According to a meta-analysis nonbenzodiazepines appear to be safer than benzodiazepines (Buscemi et al., 2007), and their risk to induce tolerance and addiction appears to be lower.”
BackgroundMeta-Analyses of Hypnotics and Infections: Eszopiclone, Ramelteon, Zaleplon, and Zolpidem
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“, 2002), there are greater longterm effects of CBTi (Buscemi et al., 2007; Riemann & Perlis, 2009; Sivertsen, Omvik, et al., 2006).”
BackgroundChapoutot, M., Peter-Derex, L., Bastuji, H., Leslie, W., Schoendorff, B., Heinzer, R., Siclari, F., Nicolas, A., Lemoine, P., Higgins, S., et al. (2021) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph181910222 · Cited by 59
“BZDs are effective in the treatment of anxiety disorders [2–4] and insomnia [5,6].”
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“Most clinicians agree that acute insomnia may be treated with hypnotics in a safe and effective way (Buscemi, Vandermeer, Friesen et al., 2007), but chronic drug use (beyond one month) is discouraged.”
Challenges and opportunities in insomnia disorder
Roach, M., Juday, T. R., Tuly, R., Chou, J. W., Jena, A. B., & Doghramji, P. P. (2020) · International Journal of Neuroscience · doi:10.1080/00207454.2020.1773460 · Cited by 65
“Furthermore, most hypnotics are respiratory suppressants that can worsen obstructive sleep apnea or hypoventilation [48,58,59].”
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Insomnia Management: A Review and Update
Shaha, D. P. (2023) · The Journal of Family Practice · doi:10.12788/jfp.0620 · Cited by 66
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Role of 5-HT2A receptor antagonists in the treatment of insomnia
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“Sedating antidepressants also are often prescribed off-label and used to improve symptoms of insomnia.(9,10) Two drugs, extended-release zolpidem and eszopiclone, are currently approved in the US for the treatment of both sleep-onset insomnia and SMI.”
Psychological Treatment of Hypnotic-Dependent Insomnia in a Primarily Older Adult Sample
Lichstein, K. L., Nau, S. D., Wilson, N. M., Aguillard, R. N., Lester, K. W., Bush, A. J., & McCrae, C. S. (2013) · Behaviour Research and Therapy · doi:10.1016/j.brat.2013.09.006 · Cited by 54
“In a tradeoff for modest therapeutic gains (Buscemi et al., 2007), hypnotic impairment exposes users to elevated risk for serious accidents (Shuto et al.”
BackgroundTheadom, A., Barker-Collo, S. L., Jones, K., Dudley, M., Vincent, N., & Feigin, V. L. (2017) · Clinical Rehabilitation · doi:10.1177/0269215517736671 · Cited by 57
“work, which could interfere in the establishment of a regular sleep/wake pattern; (6) have a medically unstable condition that could impact on the results (e.”
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The Effects of Music Intervention on Sleep Quality in Community-Dwelling Elderly
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Herring, W. J., Roth, T., Krystal, A. D., & Michelson, D. (2019) · Journal of Sleep Research · doi:10.1111/jsr.12782 · Cited by 53
“…it appears that suvorexant has greater objective than subjective efficacy, at least with regard to sleep maintenance, whereas the opposite appears to be true for GABAergic drugs (greater subjective than objective efficacy; Buscemi et al., 2007; Holbrook, Crowther, Lotter, Cheng, & King, 2000).”
Background
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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