Trazodone for sleep disturbance after alcohol detoxification: a double-blind, placebo-controlled trial.
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.
Friedmann
Peter D
PD
Program to Integrate Psychosocial and Health Services, Research Service, Providence Veterans Affairs Medical Center, Providence, Rhode Island, USA. pfriedmann@lifespan.org
Rose
Jennifer S
JS
Swift
Robert
R
Stout
Robert L
RL
Millman
Richard P
RP
Stein
Michael D
MD
D000328:Adult; D000437:Alcoholism / Q000628:therapy*; D014151:Anti-Anxiety Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002492:Central Nervous System Depressants / Q000493:pharmacokinetics*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D000431:Ethanol / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D008658:Inactivation, Metabolic; D008297:Male; D008875:Middle Aged; D012893:Sleep Wake Disorders / Q000188:drug therapy*; D014196:Trazodone / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D014151:Anti-Anxiety Agents; D002492:Central Nervous System Depressants; D000431:Ethanol; D014196:Trazodone