Melatonin for rapid eye movement sleep behavior disorder in Parkinson's disease: A randomised controlled trial.
Study Goal
The researchers aimed to assess the efficacy of prolonged-release melatonin (4 mg) for reducing REM-sleep behavior disorder symptoms in Parkinson's disease patients.
Results Summary
The study found no significant difference in RBD incidents between the melatonin and placebo groups (3.4 vs. 3.6 events/week). Adverse events were mild and similar in both groups.
Population
30 Parkinson's disease patients with REM-sleep behavior disorder.
Effective Dosage
4 mg orally once daily before bedtime.
Duration
8 weeks of intervention.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
prolonged-release (PR) melatonin (Circadin) 4 mg | no change | rapid eye movement sleep behavior disorder incidents | PD patients with rapid eye movement sleep behavior disorder | no significant change | did not reduce | #1 |
prolonged-release (PR) melatonin (Circadin) 4 mg | no change | aggregate of rapid eye movement sleep behavior disorder incidents averaged over weeks 5 to 8 of treatment | PD patients with rapid eye movement sleep behavior disorder | 3.4 events/week melatonin vs. 3.6 placebo; difference, 0.2; 95% confidence interval = -3.2 to 3.6; P = 0.92 | No differences between groups at the primary endpoint | #2 |
BACKGROUND: Melatonin may reduce REM-sleep behavior disorder (RBD) symptoms in Parkinson's disease (PD), though robust clinical trials are lacking. OBJECTIVE: To assess the efficacy of prolonged-release (PR) melatonin for RBD in PD. METHODS: Randomized, double-blind, placebo-controlled, parallel-group trial with an 8-week intervention and 4-week observation pre- and postintervention (ACTRN12613000648729). Thirty PD patients with rapid eye movement sleep behavior disorder were randomized to 4 mg of prolonged-release melatonin (Circadin) or matched placebo, ingested orally once-daily before bedtime. Primary outcome was the aggregate of rapid eye movement sleep behavior disorder incidents averaged over weeks 5 to 8 of treatment captured by a weekly diary. Data were included in a mixed-model analysis of variance (n = 15 per group). RESULTS: No differences between groups at the primary endpoint (3.4 events/week melatonin vs. 3.6 placebo; difference, 0.2; 95% confidence interval = -3.2 to 3.6; P = 0.92). Adverse events included mild headaches, fatigue, and morning sleepiness (n = 4 melatonin; n = 5 placebo). CONCLUSION: Prolonged-release melatonin 4 mg did not reduce rapid eye movement sleep behavior disorder in PD. © 2019 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.