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Melatonin for sleep and cognitive outcomes in older adults with cognitive impairment: a meta-analysis of randomised controlled trials

Mdluli NT, Banda KJ, Chang YC

Age and ageing, 2025

516 participants · 5 citations

Abstract

OBJECTIVES

To quantify the effects of melatonin on total sleep time and global cognition, and to examine secondary outcomes (sleep efficiency, circadian markers, neuropsychiatric symptoms, depression, activities of daily living) in older adults with cognitive impairment.

DESIGN

Systematic review and meta-analysis of randomised controlled trials (PROSPERO CRD42024539227).

DATA SOURCES

PubMed, PsycINFO (via EBSCOhost), CINAHL Plus, Cochrane Library, Web of Science, to October 2024.

ELIGIBILITY CRITERIA

Randomised controlled trials (RCTs) comparing melatonin versus placebo in adults ≥65 years with mild cognitive impairment or dementia.

DATA EXTRACTION AND SYNTHESIS

Two reviewers extracted data; risk of bias was assessed by RoB 2. Random-effects models estimated Hedges' g and mean differences (MD), with Benjamini-Hochberg false discovery rate (FDR) correction for multiple outcomes. Heterogeneity assessed via I2; publication bias via Egger's test.

RESULTS

Ten RCTs (n = 516) were included. Melatonin increased total sleep time by MD +12.4 min (95% CI 8.1-16.7; P < .001; I2 = 72%; g = 0.42) and improved Mini-Mental State Examination scores by MD +1.8 points (95% CI 0.9-2.7; P = .002; I2 = 65%; g = 0.47). Neuropsychiatric symptoms decreased (g = -0.23; 95% CI -0.44 to -0.03; P = .02). Effects on sleep efficiency, circadian markers, depression and activities of daily living were small and nonsignificant.

CONCLUSIONS

Melatonin yields modest improvements in sleep duration and cognition…

How strong is the evidence?

Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 516 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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