Le Bon 2003.

Methods	Randomised, double‐blind, controlled trial
Participants	Insomnia diagnosis criteria (method of diagnosis): alcohol‐induced sleep disorders, insomnia type (DSM‐IV) Other diagnoses: alcohol dependence with physiological dependence as defined by the DSM‐IV Number of participants randomised: n = 18 Number of participants: n = 16 Age, mean (SD) years: 43.8 (8.3) Gender (M/F): 16/1 Race/ethnicity: not stated Country: Belgium Setting: Brugmann University Hospital alcohol detoxification unit up to night 3 then weekly FUs at clinic Included: aged 18‐65 years; alcohol dependence with physiological dependence as defined by the DSM‐IV; alcohol‐induced sleep disorders, insomnia type (DSM‐IV); co‐operativeness and sufficient intellectual and emotional capacity to comply with protocol requirements Excluded: history of mood, anxiety, dementia or psychosis disorder previous to the excessive consumption of alcohol; use of street drugs or non‐prescribed tranquillisers within the 12 months prior to the preinclusion visit; psychotropic drugs within 2 weeks before the preinclusion visit (anxiolytics, hypnotics, antidepressants, neuroleptics, carbamazepine, beta‐blocking agents (except if prescribed before alcohol detoxification), clonidine, antihistamines (if necessary, loratadine or terfenadine were permitted for at most 5 consecutive days), narcotic analgesics, amphetamines and related substances; severe medical condition; laboratory tests outside the normal range and deemed clinically significant by the investigator; positive alcohol screen in breath; pregnancy risk of pregnancy or lactation; use of any investigational medication within 30 days prior to the start of study or prevision to receive any investigational medicine other than the study medication during the course of the study; previous treatment with trazodone. Withdrawals: n = 2 Baseline imbalances: at day 1, no difference in weight, height, biological values, levels and duration of diazepam treatment was observed between the 2 subgroups. Night 1 was discarded to exclude potential first‐night effects and night 2 was used as the no medication baseline. Of the sleep parameters, only the arousal index was significantly greater in the trazodone group than in the placebo group.
Interventions	Intervention: trazodone 50 mg titrated up to 200 mg for 4 weeks double blind Comparator: placebo for 4 weeks (identical capsules equivalent to trazodone 50‐200 mg capsules) double blind
Outcomes	Measured on nights 2, 3 and 28 Primary outcomes SE including sleep onset latency (SE11) SE after sleep onset (SE12) Time in bed Sleep period time TST Sleep onset latency NAW Number of stage shifts Adverse events Secondary outcomes REM sleep REM sleep latency REM density Eye movements/hr Non‐REM sleep) Slow wave sleep Apnoea‐hypopnoea index Arousals Dropouts
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were randomly assigned by the statistical software (Pg 378)
Allocation concealment (selection bias)	Unclear risk	No information provided
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double blind
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Reported that blinding was maintained until the end of the study.
Incomplete outcome data (attrition bias) All outcomes	High risk	2/18 dropped out due to relapse plus no ITT mentioned (Pg 380)
Selective reporting (reporting bias)	Unclear risk	ITT analysis not mentioned
Other bias	High risk	Sponsored by a pharmaceutical company with no evidence of independence of results reported