Garfinkel 1999.

Methods	Study design: Randomised controlled trial Study grouping: Parallel group Blinding: Double Duration: 6 weeks double‐blind, 6 weeks single‐blind Single‐centre
Participants	Baseline characteristics Controlled‐release melatonin Male, N (%): 4 (22) Age, mean (SD): 69 (11) Number of benzodiazepine tablets, mean (SD): 1.08 (0.38) Placebo Male, N (%): 5 (31) Age, mean (SD): 68 (16) Number of benzodiazepine tablets, mean (SD): 1.23 (0.61) Inclusion criteria: People with a daily use of benzodiazepines for more than 6 months, expressed willingness to discontinue the use, living independently Exclusion criteria: Cognitive impairment, liver or renal disorders Pretreatment: No significant differences
Interventions	Intervention characteristics Benzodiazepine taper schedule: participants were encouraged to reduce their usual benzodiazepine therapy dosage 50% during week 2, 75% during weeks 3 and 4, and then to discontinue benzodiazepine therapy completely during weeks 5 and 6. Participants who did not succeed in stopping benzodiazepine therapy during period 1 were encouraged to further reduce benzodiazepine dosage 50%, 75%, and 100% during weeks 8, 9 and 10, 11 and 12, respectively. Benzodiazepine taper schedule + controlled‐release melatonin 2 mg/d (2 hours before bedtime)(N = 18) Benzodiazepine taper schedule + placebo(N = 16)
Outcomes	Benzodiazepine cessation Sleep quality (scale 1 to 10, higher = better)
Identification	Sponsorship source: Neurim Pharmaceuticals sponsored study medication and study nurse; statistical evaluations performed independently. Country: Israel Setting: Outpatients, living independently Declarations of interest: Not mentioned Authors name: Doron Garfinkel Institution: Department of Neurobiochemistry, Tel Aviv University Email: Navazis@ccsg.tau.ac.il Address: Tel Aviv 69978, Israel
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: Not described
Allocation concealment (selection bias)	Unclear risk	Comment: Not described
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Subjects were randomised to receive either 2 mg of CRM therapy or a placebo that was identical in appearance"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Collection and entry of all data were completed before revealing the randomisation codes of the study"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: All included participants analysed.
Selective reporting (reporting bias)	Low risk	Comment: No indications of selective reporting
Other bias	High risk	Comment: The trial was partly financed by a company with an interest in given result, the company's role in interpreting the data is not sufficiently described.