Safety and Efficacy of Melatonin for Sleep Disorders in Cancer: A Systematic Review and Meta-Analysis of Randomized Clinical Trials
Abstract
INTRODUCTION/OBJECTIVE
Sleep disruption is common among patients with malignancy and may worsen quality of life, treatment tolerance, and symptom burden. Melatonin is a circadianregulating hormone with a favorable safety profile and potential sleep-promoting effects. This metaanalysis and systematic review evaluated the safety and efficacy of melatonin for sleep-related outcomes in patients with cancer.
METHODS
Scopus, PubMed, Web of Science, ScienceDirect, Cochrane Library, ClinicalTrials.gov, and EMBASE were systematically searched from inception to 1 June 2026 without language or country restrictions. Randomized clinical trials comparing melatonin with placebo or an active control in patients with cancer and reporting sleep-related outcomes were eligible. Data extraction, study selection, and riskof- bias assessment using the Joanna Briggs Institute checklist were performed by two reviewers independently. Random-effects meta-analyses with Hartung-Knapp adjustment were conducted in Stata 17.0.
RESULTS
Data from seven studies were pooled in the meta-analysis, and thirteen articles were included in the systematic review. The overall effect of melatonin was insignificant (SMD = -0.85 with a 95% CI of -2.46 to 0.76) with high heterogeneity among studies (I2 = 94.5%). Subgroup analysis revealed a significant decrease in the Pittsburgh Sleep Quality Index (PSQI) in US studies (SMD = -0.57, 95% CI: [-0.99, -0.14], I2 = 31.5%). Meta-analysis of the seven PSQI components showed no…
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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.
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