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 We searched key databases and trial registers up to March 2014 and contacted pharmaceutical companies and the FDA for unpublished data.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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Low doses of doxepin (3 and 6 mg) were approved by the FDA for the treatment of insomnia.
“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]
Many TCAs, including doxepin, have a very strong sedating effect.
“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]
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- 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 › 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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