Factors influencing the effect of melatonin on sleep quality in children with autism spectrum disorder: a systematic review and meta-analysis

Yang et al., 2025 | Sleep Breath | Meta Analysis

Citation

Yang Hao, Lu Feng, Zhao Xiaoyan. Factors influencing the effect of melatonin on sleep quality in children with autism spectrum disorder: a systematic review and meta-analysis. Sleep Breath. 2025-Aug-06;29(4):262. doi:10.1007/s11325-025-03432-x

Abstract

Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by impaired social interaction and communication. The prevalence of ASD has risen globally. Sleep disturbances exacerbates the core symptoms of children with ASD, and numerous studies demonstrated that melatonin is efficacious in treating autism-related insomnia in children. This study intended to comprehensively analyze the therapeutic effects of melatonin on sleep disturbances in children with autism, focusing on effect sizes across different treatment parameters, including medication dosage, type, treatment course, and the age of the children. Additionally, the analysis examines the effects of melatonin on various sleep indicators. Through systematic review and meta-analyses, data from existing studies were collected and categorizing them based on medication parameters and the age of the participants. The influence of melatonin on multiple sleep indicators was evaluated, revealing that melatonin significantly improves sleep quality and total sleep time in children with autism. The Hedges' g values for these two indicators were 0.75 and 0.58, with both P-values less than 0.05. The overall effect of melatonin displayed a parabolic relationship with dosage, achieving its optimal effectiveness at approximately 5.7 mg. Subject age also influenced the therapeutic effect with optimal results observed in children aged 10 years and older, where the Hedges' g effect size reached 0.09. Melatonin shows substantial effectiveness in improving the sleep in children with ASD, with minimal and mild adverse reactions. These findings support the development of individualized treatment approaches for melatonin administration in this population.

Key Findings

These findings support the development of individualized treatment approaches for melatonin administration in this population.

Outcomes Measured

  • sleep quality

Population

Field Value
Population See abstract
Sample Size See abstract
Age Range See abstract
Condition insomnia

MeSH Terms

  • Humans
  • Melatonin
  • Autism Spectrum Disorder
  • Child
  • Sleep Quality
  • Sleep Initiation and Maintenance Disorders

Evidence Classification

  • Level: Meta Analysis
  • Publication Types: Journal Article, Systematic Review, Meta-Analysis, Research Support, Non-U.S. Gov't
  • Vertical: melatonin-children

Provenance


Source extracted via PubMed E-utilities API on 2026-04-09