Evaluating the efficacy and safety of melatonin for sleep onset insomnia in children aged 6–12: a systematic review and meta-analysis

Background Melatonin is an endogenous hormone that regulates the body’s sleep-wake cycles. Due to several clinical trials, it is currently used as an exogenous supplement in pediatric patients who suffer from sleep-onset insomnia (SOI). Consequently, this systematic review and meta-analysis aimed to assess the evidence for the clinical efficacy of melatonin for SOI in children aged 6–12. Methods This systematic review and meta-analysis evaluated the efficacy and safety of Melatonin for sleep-onset insomnia in children aged 6–12 by conducting literature searches in PubMed (97), Google Scholar (111), OVID (33), and Web of Science (156) databases. We performed statistical tests using RevMan for meta-analysis. Heterogeneity was evaluated using the I2 statistic. To maintain the validity of the studies, each included study was assessed by the Cochrane Collaboration Risk of Bias (ROB) tool. The outcomes investigated were sleep onset time (SOT), sleep onset latency (SOL), total sleep time (TST), all-cause dropout rates, and adverse-event dropout rates. Results Three hundred ninety-eight records were identified, and 10 randomized clinical trials met the inclusion criteria. The results demonstrated that melatonin treatment group was associated with an earlier sleep onset time compared with placebo with a mean difference (MD) of -0.48 h (approximately 29 min earlier) (95% confidence interval [CI]: -0.93 to -0.02 h, p = 0.04). The heterogeneity between studies was moderate (I2 = 63%). On the other hand, it was noted that there has been noticed there was a remarkable reduction in sleep onset latency with melatonin compared to placebo, with an MD of -0.38 (95% CI: -0.57 to -0.20, p < 0.0001), with high heterogeneity (I2 = 82%). Conclusion Our study confirmed that melatonin has a marked effect regarding Sleep-onset insomnia in childhood. Therefore, we found there was a statistical and clinical improvement in sleep parameters such as sleep onset time (SOT) and total sleep time (TST) which demonstrated the safety and efficacy of melatonin. However, long-term efficacy and safety need to be addressed, especially in the pediatric population.