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Trazodone for sleep disturbance after alcohol detoxification: a double-blind, placebo-controlled trial
Open accessAbstract
BACKGROUND: Trazodone is a commonly prescribed off-label for sleep disturbance in alcohol-dependent patients, but its safety and efficacy for this indication is unknown. METHODS: We conducted a randomized, double-blind, placebo-control trial of low-dose trazodone (50 to 150 mg at bedtime) for 12 weeks among 173 alcohol detoxification patients who reported current sleep disturbance on a validated measure of sleep quality or during prior periods of abstinence. Primary outcomes were the proportion of days abstinent and drinks per drinking day over 6-months; sleep quality was also assessed. RESULTS: Urn randomization balanced baseline features among the 88 subjects who received trazodone and 85 who received placebo. The trazodone group experienced less improvement in the proportion of days abstinent during administration of study medication (mean change between baseline and 3 months: -0.12; 95% CI: -0.15 to -0.09), and an increase in the number of drinks per drinking day on cessation of the study medication (mean change between baseline and 6 months, 4.6; 95% CI: 2.1 to 7.1). Trazodone was associated with improved sleep quality during its administration (mean change on the Pittsburgh Sleep Quality Index between baseline and 3 months: -3.02; 95% CI: -3.38 to -2.67), but after it was stopped sleep quality equalized with placebo. CONCLUSIONS: Trazodone, despite a short-term benefit on sleep quality, might impede improvements in alcohol consumption in the postdetoxification period and lead to increased drinking when stopped. Until further studies have established benefits and safety, routine initiation of trazodone for sleep disturbance cannot be recommended with confidence during the period after detoxification from alcoholism.
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“While some of the pharmacological intervention studies may have been underpowered to detect secondary outcomes, Friedmann and colleagues (2008) were sufficiently powered to detect changes in abstinence as a function of treatment and did document improvements in sleep quality as a result of treatment with trazodone.”
From Insomnia treatment in the context of alcohol use disorder: A systematic review and meta-analysis (2017) · cites this paper as Friedmann et al., 2008
In the citing paper
“While some of the pharmacological intervention studies may have been underpowered to detect secondary outcomes, Friedmann and colleagues (2008) were sufficiently powered to detect changes in abstinence as a function of treatment and did document improvements in sleep quality as a result of treatment with trazodone.”
From Insomnia treatment in the context of alcohol use disorder: A systematic review and meta-analysis (2017) · cites this paper as Friedmann et al., 2008
In the citing paper
“However, their sample also consisted of recently detoxified patients, only 25% of whom had engaged in formal substance use treatment by one-month follow-up.”
From Insomnia treatment in the context of alcohol use disorder: A systematic review and meta-analysis (2017) · cites this paper as Friedmann et al., 2008
In the citing paper
“However, in contrast to hypotheses, they found that participants in the trazodone group reported a smaller increase in abstinent days than those in the placebo group.”
From Insomnia treatment in the context of alcohol use disorder: A systematic review and meta-analysis (2017) · cites this paper as Friedmann et al., 2008
In the citing paper
“Adult sleep treatment studies in recovering drinkers consistently report improvements in sleep, but either indeterminate effects on alcohol outcomes in cognitive-behavioral treatment studies (Arnedt et al., 2007; Arnedt, Conroy, Armitage, & Brower, 2011; Currie, Clark, Hodgins, & El-Guebaly, 2004) or worse alcohol outcomes following pharmacological treatment (Friedmann et al., 2008).”
From Sleep and circadian contributions to adolescent alcohol use disorder (2015) · cites this paper as Friedmann et al., 2008
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Self-citationDrugs for Insomnia beyond Benzodiazepines: Pharmacology, Clinical Applications, and Discovery
Atkin, T., Comai, S., & Gobbi, G. (2018) · Pharmacological Reviews · doi:10.1124/pr.117.014381 · Cited by 400
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Metadata
- Authors
- Friedmann, P. D., Rose, J. S., Swift, R., Stout, R. L., Millman, R. P., & Stein, M. D.
- Affiliations
- Brown University (US)
- Corresponding author
- Friedmann, Peter D.
- ORCID
- Venue
- Alcoholism Clinical and Experimental Research
- Publisher
- Wiley
- Published
- 2008-08-25
- Volume
- 32
- Issue
- 9
- Pages
- 1652-1660
- ISSN
- 0145-6008 (ISSN-L)
- 1530-0277
- PMC
- PMC2567128
- OpenAlex
- W2091013876
- Cited by
- 116
- References
- 42
- Citations by year
- 2026: 4 · 2025: 9 · 2024: 12 · 2023: 7 · 2022: 6 · 2021: 6 · 2020: 8 · 2019: 5 · 2018: 13 · 2017: 5 · 2016: 7 · 2015: 7 · 2014: 5 · 2013: 5 · 2012: 4
- FWCI
- 5.91
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Alcoholism Clinical and Experimental Research (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute on Alcohol Abuse and Alcoholism (R01AA13243, R01AA013243)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Clinical Neurology › Alcoholism and Thiamine Deficiency
- Keywords
- trazodone, sleep disorders, alcohol detoxification, alcoholism, sleep quality, alcohol abstinence, relapse, off-label drug use
- MeSH terms
- Adult, Ethanol, Alcoholism, Central Nervous System Depressants, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Inactivation, Metabolic, Middle Aged, Sleep Wake Disorders, Anti-Anxiety Agents, Trazodone, Treatment Outcome
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