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

Abstract

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.

• Authors: Moran Gilat, Alessandra Coeytaux Jackson, Nathaniel S Marshall, Deborah Hammond, Anna E Mullins, Julie M Hall, Bernard A M Fang, Brendon J Yee, Keith K H Wong, Ron R Grunstein, Simon J G Lewis
• Journal: Movement disorders : official journal of the Movement Disorder Society (Mov Disord) Vol. 35 Issue 2 Pg. 344-349 (02 2020) ISSN: 1531-8257 [Electronic] United States
• PMID: 31674060 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2019 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

Chemical References

• Clonazepam
• Melatonin

Topics

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