Melatonin in pediatric populations: promise or peril?

This review summarizes both the current evidence from clinical trials examining the use of exogenous melatonin for insomnia in children and adolescents and the recent literature raising potential concerns regarding melatonin as an over-the-counter (OTC) supplement. Given a number of caveats and the existence of remaining knowledge gaps, the overall aim of the review is to assist healthcare practitioners in decision-making for their pediatric patients and families.

While the evidence base supporting the efficacy and tolerability of melatonin for insomnia for children with neurodevelopmental disorders such as autism is generally considered robust, the literature in typically developing children is comparatively small. Studies over the past decade have raised concerns regarding the exponential increase in melatonin use in pediatric populations, reliability of the content of OTC melatonin products, the increase in accidental ingestions, especially in young children, and potential misuse of melatonin for unsupported indications.

While melatonin has a role in the management of pediatric insomnia as well as of circadian rhythm disorders, the existing literature supports behavioral interventions as the first-line treatment option. Potential pitfalls in the clinical use of melatonin in children are important to recognize and incorporate into best-practice recommendations.