INTRODUCTION: Up to 80% of children and adolescents with autism spectrumdisorders (ASD) has a sleep disorder, in whose genesis some alterations in theregulation of melatonin are apparently involved. The aim of this meta-analysis was todetermine the efficacy and safety of melatonin for management of certain sleepdisorders in children with ASD.METHODS: Three reviewers extracted relevant data from high-quality double-blindrandomized clinical trials published in primary, clinical trials, systematic reviews andgray literature databases; further search was conducted in snowball. Data wereanalyzed with RevMan 5.3. An inverse of variance analysis by random-effects modelwas made for the mean differences of the proposed outcomes was performed (totalsleep time, sleep onset latency and number of nighttime awakenings). Inter-studyheterogeneity was evaluated with I2 parameter.RESULTS: The initial search yielded 355 results, of which three met the selectioncriteria. Melatonin was found to be a safe and effective drug to increase total sleeptime and decrease sleep onset latency in children and adolescents with ASD; so farthe evidence on the number of night awakenings is not statistically significant.DISCUSSION: According to available evidence, melatonin is a safe and effectivechoice for managing certain sleep problems in children and adolescents with ASD.Studies are needed with larger sample sizes and comparing with other drugs availablein the market.
