Aims: To evaluate the effectiveness of melatonin in attenuating sleep difficulties during benzodiazepine (BDZ) withdrawal.
Design: Double-blind cross-over control study.
Setting: Methadone maintenance treatment clinic.
Participants: Eighty patients enrolled at a community methadone maintenance clinic recruited to a BDZ withdrawal programme.
Intervention: Melatonin (5 mg/day) or placebo: 6 weeks one arm, 1 week washout, 6 weeks other arm.
Measurements: Urine BDZ; self-reported Pittsburgh Sleep Quality Index (PSQI) and the Center for Epidemiologic Studies Depression (CES-D) questionnaires administered at baseline, and at 6, 7 and 13 weeks.
Findings: Sixty-one patients (77.5% in the 'melatonin first' condition and 75% in the 'placebo first' condition) completed 6 weeks of treatment, showing a similar BDZ discontinuation rate of 11/31 and 11/30, respectively. PSQI scores were significantly lower (indicating better sleep quality) in the 22 patients who discontinued BDZ (8.9 +/- 0.9) than in 39 with urine BDZ (11.2 +/- 0.7, P = 0.04). Sleep quality in patients who continued abusing BDZ improved more in the 'melatonin first' group than in the 'placebo first' group, with no differences in sleep quality improvement in patients who stopped BDZ. CONCLUSION Most improvement in sleep quality was attributed to BDZ discontinuation. Although melatonin did not enhance BDZ discontinuation, it improved sleep quality, especially in patients who did not stop BDZ.
Trial registration: ClinicalTrials.gov NCT00261183.