EFFICACY AND SAFETY OF PROLONGED-RELEASE MELATONIN USE IN CHILDREN WITH NEURODEVELOPMENTAL DISORDERS: A SYSTEMATIC REVIEW

Abstract

This article sought to evaluate the efficacy and safety of prolonged-release melatonin use in children and adolescents with neurodevelopmental disorders and associated sleep disturbances. A systematic literature review was conducted according to the PRISMA 2020 recommendations and structured using the PICO strategy. Searches were performed in the PubMed, SciELO, and Virtual Health Library databases, considering studies published between 2016 and 2026. After applying the eligibility criteria, eight studies were included in the review. The results demonstrated a reduction in sleep-onset latency, an increase in total sleep time, and improvement in sleep continuity. Benefits related to daytime behavior and caregivers’ quality of life were also reported. The most frequently reported adverse events were fatigue, somnolence, and mood changes, with no relevant evidence of impairment in growth or pubertal development in long-term follow-up studies. It was concluded that prolonged-release melatonin shows favorable results regarding efficacy and safety in this population, although methodological heterogeneity and the limited number of long-term studies indicate the need for further research.