The DOI matches its Crossref record; 27 of the 29 references it cites were found in a registry or an index.
Doxepin for insomnia: A systematic review of randomized placebo-controlled trials
Abstract
Doxepin, a sedating tricyclic drug, at 3 mg and 6 mg doses was recently approved by the U.S. food and drug administration (FDA) for the treatment of insomnia. The objective of this systematic review was to obtain a precise summary of the efficacy and safety of doxepin as a hypnotic. We searched key databases and trial registers up to March 2014 and contacted pharmaceutical companies and the FDA for unpublished data. A total of nine randomized placebo-controlled trials were analyzed. Six studies were on doxepin 1-6 mg/d, two on doxepin 25-300 mg/d, and one on ramelteon 8 mg and doxepin 3 mg combined. All low-dose studies were industry-sponsored. We found that low-dose doxepin had a small to medium effect size against placebo for sleep maintenance and sleep duration but not for sleep initiation at both immediate and short-term posttreatment. There was no significant next-day residual effect with low-dose doxepin. Headache and somnolence were the most common side effects. We concluded that low-dose doxepin for 1-2 nights appeared to be safe and effective in improving sleep. However, a clear conclusion on its short-term benefits and risks as well as withdrawal effects was not possible due to the small number of studies.
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In the citing paper
“Thus, low doses of doxepin (3 and 6 mg) were approved by the FDA for the treatment of insomnia.77”
From Addressing the Side Effects of Contemporary Antidepressant Drugs: A Comprehensive Review (2018) · cites this paper as [77]
In the citing paper
“Many TCAs, including doxepin, have a very strong sedating effect.”
From Addressing the Side Effects of Contemporary Antidepressant Drugs: A Comprehensive Review (2018) · cites this paper as [77]
Citations
Cites
Diagnostic and Statistical Manual of Mental Disorders
Williams, J. B. W., & First, M. B. (2013) · Oxford University Press eBooks · doi:10.1093/acrefore/9780199975839.013.104 · Cited by 109,845
Liberati, A., Altman, D. G., Tetzlaff, J., Mulrow, C., Gøtzsche, P. C., Ioannidis, J. P. A., Clarke, M., Devereaux, P. J., Kleijnen, J., & Moher, D. (2009) · PLoS Medicine · doi:10.1371/journal.pmed.1000100 · Cited by 28,164
Cochrane Handbook for Systematic Reviews of Interventions: Cochrane Book Series
(2008) · doi:10.1002/9780470712184 · Cited by 25,048
Liberati, A., Altman, D. G., Tetzlaff, J., Mulrow, C., Gøtzsche, P. C., Ioannidis, J. P. A., Clarke, M., Devereaux, P. J., Kleijnen, J., & Moher, D. (2009) · Annals of Internal Medicine · doi:10.7326/0003-4819-151-4-200908180-00136 · Cited by 10,349
The International Classification of Sleep Disorders
Greenblatt, D. (1992) · Archives of Neurology · doi:10.1001/archneur.1992.00530270020006 · Cited by 4,406
Epidemiology of insomnia: what we know and what we still need to learn
Ohayon, M. M. (2002) · Sleep Medicine Reviews · doi:10.1053/smrv.2002.0186 · Cited by 3,743
Clinical Guideline for the Evaluation and Management of Chronic Insomnia in Adults
Schutte-Rodin, S., Broch, L., Buysse, D., Dorsey, C., & Sateia, M. (2008) · Journal of Clinical Sleep Medicine · doi:10.5664/jcsm.27286 · Cited by 1,943
Diagnostic and Statistical Manual of Mental Disorders
Multon, K. D., & Suitor, D. (2008) · Sage eBooks · doi:10.4135/9781412963848.n66 · Cited by 859
Wilson, S., Nutt, D., Alford, C., Argyropoulos, S., Baldwin, D., Bateson, A., Britton, T., Crowe, C., Dijk, D.-J., Espie, C., et al. (2010) · Journal of Psychopharmacology · doi:10.1177/0269881110379307 · Cited by 634
The Efficacy and Safety of Drug Treatments for Chronic Insomnia in Adults: A Meta-Analysis of RCTs
Buscemi, N., Vandermeer, B., Friesen, C., Bialy, L., Tubman, M., Ospina, M., Klassen, T. P., & Witmans, M. (2007) · Journal of General Internal Medicine · doi:10.1007/s11606-007-0251-z · Cited by 448
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Metadata
- Authors
- Yeung, W.-F., Chung, K.-F., Yung, K.-P., & Ng, T. H.-Y.
- Affiliations
- University of Hong Kong (HK)
- Corresponding author
- Chung, Ka-Fai
- Venue
- Sleep Medicine Reviews
- Publisher
- Elsevier BV
- Published
- 2015-02
- Volume
- 19
- Pages
- 75-83
- ISSN
- 1087-0792 (ISSN-L)
- OpenAlex
- W2007788592
- Cited by
- 126
- References
- 29
- Citations by year
- 2026: 7 · 2025: 14 · 2024: 11 · 2023: 14 · 2022: 10 · 2021: 10 · 2020: 9 · 2019: 17 · 2018: 12 · 2017: 9 · 2016: 11 · 2015: 2
- FWCI
- 0.99
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Sleep Medicine Reviews (publishedVersion)
- PubMed (publishedVersion)
- The HKU Scholars Hub (University of Hong Kong) (submittedVersion)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Health Sciences › Medicine › Physiology (medical) › Obstructive Sleep Apnea Research
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Circadian rhythm and melatonin
- Keywords
- doxepin, insomnia, hypnotics, tricyclic antidepressants, sleep maintenance, sleep duration, sleep initiation, headache, sleepiness, drug safety, drug efficacy
- MeSH terms
- Adolescent, Adult, Aged, Aged, 80 and over, Dose-Response Relationship, Drug, Doxepin, Drug Therapy, Combination, Female, Humans, Indenes, Sleep Initiation and Maintenance Disorders, Male, Middle Aged, United States, United States Food and Drug Administration, Randomized Controlled Trials as Topic, Treatment Outcome, Young Adult
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