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

Mov Disord. 2020 Feb;35(2):344-349. doi: 10.1002/mds.27886. Epub 2019 Oct 31.


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.

Keywords: Parkinson's disease; REM sleep behavior disorder; melatonin; randomized controlled trial; sleep disorders.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Clonazepam / therapeutic use
  • Double-Blind Method
  • Eye Movements / drug effects*
  • Fatigue / drug therapy
  • Female
  • Humans
  • Male
  • Melatonin / metabolism
  • Melatonin / therapeutic use*
  • Middle Aged
  • Parkinson Disease / drug therapy*
  • Polysomnography / methods
  • REM Sleep Behavior Disorder / diagnosis
  • REM Sleep Behavior Disorder / drug therapy*


  • Clonazepam
  • Melatonin