Meta-analysis of randomized, double-blind, placebo-controlled trials of melatonin in Alzheimer's disease

Int J Geriatr Psychiatry. 2017 Jan;32(1):50-57. doi: 10.1002/gps.4571. Epub 2016 Sep 19.


Objective: This is a meta-analysis of randomized controlled trials (RCTs) of the efficacy of melatonin in Alzheimer's disease (AD).

Methods: Both English (PubMed, PsycINFO, Embase, Cochrane Library databases, and the Cochrane Controlled Trials Register) and Chinese (WanFang Database, Chinese Biomedical Database, and China Journal Net) databases were systematically and independently searched by two authors from their inception until 1 March 2016. Weighted and standard mean differences (SMDs), risk ratio (RR) ±95% confidence intervals (CIs) were calculated. In all cases, the random effects model was used.

Results: Seven studies (n = 462) with the duration ranging from 10 days to 24 weeks were identified and analyzed. AD patients receiving melatonin treatment showed prolonged total sleep time at night (n = 305; SMD: 0.26, 95% CI: 0.01 to 0.51, I2 = 9%, p = 0.04). Melatonin did not improve cognitive abilities assessed by the mini-mental state examination and the Alzheimer's Disease Assessment Cognitive Subscale. The discontinuation rate was similar between the melatonin and placebo groups (n = 453, RR = 0.77, 95% CI: 0.51 to 1.16, I2 = 0%, p = 0.21).

Conclusion: Melatonin appears to be effective and safe in improving sleep quality in patients with AD. Copyright © 2016 John Wiley & Sons, Ltd.

Keywords: Alzheimer's disease; melatonin; meta-analysis; placebo.

Publication types

  • Meta-Analysis
  • Review

MeSH terms

  • Alzheimer Disease / drug therapy*
  • Alzheimer Disease / physiopathology
  • Alzheimer Disease / psychology
  • Double-Blind Method
  • Humans
  • Melatonin / pharmacology*
  • Melatonin / therapeutic use*
  • Randomized Controlled Trials as Topic
  • Sleep / drug effects*


  • Melatonin