Melatonin for rapid eye movement sleep behavior disorder in Parkinson's disease: A randomised controlled trial.

Abstract

BackgroundMelatonin may reduce REM‐sleep behavior disorder (RBD) symptoms in Parkinson's disease (PD), though robust clinical trials are lacking.ObjectiveTo assess the efficacy of prolonged‐release (PR) melatonin for RBD in PD.MethodsRandomized, 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).ResultsNo 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).ConclusionProlonged‐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.