Prolonged-release melatonin in Parkinson's disease patients with a poor sleep quality: A randomized trial

Parkinsonism Relat Disord. 2020 Jun:75:50-54. doi: 10.1016/j.parkreldis.2020.03.029. Epub 2020 May 16.

Abstract

Background: The present study was a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the efficacy and safety of prolonged-release melatonin (PRM) in Parkinson's disease (PD) patients with poor sleep quality.

Methods: PD patients with a global Pittsburgh Sleep Quality Index (PSQI) score > 5 were included. Patients were assessed using the PSQI, a rapid eye movement sleep behavior disorder screening questionnaire, the Epworth Sleepiness Scale, Non-Motor Symptoms Scale (NMSS), Parkinson's Disease Quality of Life-39 (PDQ-39), and Unified Parkinson's Disease Rating Scale (UPDRS)-III at the beginning of the study and after 4 weeks of treatment with 2 mg of PRM. Partial correlation analysis was performed to investigate the relationship between PSQI score and the other scales.

Results: Thirty-four PD patients with poor sleep quality were enrolled and divided into 2 groups based on medication; PRM (n = 16) and placebo (n = 18). Regarding efficacy, PSQI was significantly improved in the PRM group compared to the control group. Improvement in the NMSS and PDQ-39 summary index were observed in the PRM but not in the placebo group; UPDRS-III score was not significantly changed in either group. PSQI improvement correlated with improvement in NMSS score and PDQ-39 summary index. Regarding safety, all enrolled subjects did not complain of side effects due to PRM.

Conclusion: PRM is an effective and safe treatment option for subjective sleep quality in PD patients and beneficial effects on sleep quality are associated with improved non-motor symptoms and quality of life in PD patients.

Keywords: Circadian rhythm; Melatonin; Parkinson's disease; Prolonged-release melatonin; Sleep disturbance.

Publication types

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

MeSH terms

  • Adult
  • Central Nervous System Depressants / administration & dosage
  • Central Nervous System Depressants / pharmacology*
  • Circadian Rhythm / drug effects
  • Delayed-Action Preparations
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Melatonin / administration & dosage
  • Melatonin / pharmacology*
  • Middle Aged
  • Parkinson Disease / complications*
  • Parkinson Disease / drug therapy*
  • Sleep Wake Disorders / drug therapy*
  • Sleep Wake Disorders / etiology*
  • Treatment Outcome

Substances

  • Central Nervous System Depressants
  • Delayed-Action Preparations
  • Melatonin