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Randomized Controlled Trial
. 2008 Sep;32(9):1652-60.
doi: 10.1111/j.1530-0277.2008.00742.x. Epub 2008 Jul 8.

Trazodone for sleep disturbance after alcohol detoxification: a double-blind, placebo-controlled trial

Peter D Friedmann  1 , Jennifer S Rose, Robert Swift, Robert L Stout, Richard P Millman, Michael D Stein
Affiliations
Randomized Controlled Trial

Trazodone for sleep disturbance after alcohol detoxification: a double-blind, placebo-controlled trial

Peter D Friedmann et al. Alcohol Clin Exp Res. 2008 Sep.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00027053.

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Figures

Figure 1
Figure 1
CONSORT Flowchart
Figure 2a
Figure 2a
Trajectory of Abstinence Days
Figure 2b
Figure 2b
Trajectory of Drinks per Drinking Days
Figure 2c
Figure 2c
Trajectory of Heavy Drinking Days
Figure 2d
Figure 2d
Trajectory of Abstinence Days by Treatment Adherence
See this image and copyright information in PMC

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