Melatonin has become one of the most commonly used sleep aids for children worldwide, driven by its reputation as a natural and accessible remedy for insomnia. However, emerging evidence suggests that its rapid adoption has far outpaced scientific understanding of its long-term safety and effectiveness across pediatrics. While melatonin shows a clear benefit for sleep problems among children with neurodevelopmental disorders, robust data remain limited for typically developing children. Additional concerns include inconsistent dosing in over-the-counter products, inappropriate use without medical guidance, and rising cases of accidental ingestion. Together, these findings highlight the need for caution, better regulation, and stronger evidence-based guidance when melatonin is used to manage childhood sleep problems.
Sleep problems are increasingly common among children and adolescents, affecting emotional regulation, cognitive development, and healthy conditions. As families are seeking quick and accessible solutions, melatonin supplements have gained widespread popularity due to their availability, child-friendly formulations, and perception as a safe, natural alternative to prescription drugs. Yet melatonin is a kind of hormone that influences not only sleep–wake rhythms but also immune, metabolic, and reproductive systems. Current research on pediatric melatonin use is uneven, with most studies focusing on short-term outcomes or specific clinical patients. Therefore, there is a critical need to systematically evaluate the safety, efficacy, and appropriate use of melatonin in children.
A narrative review published (DOI: 10.1007/s12519-025-00896-5) in World Journal of Pediatrics on April 30, 2025, by researchers at Boston Children's Hospital, examines the growing global use of melatonin among pediatric populations. This review synthesizes the clinical evidence on effectiveness, safety profile, and real-world use patterns in children and adolescents. It highlights major gaps between widespread consumption and limited long-term data, raising concerns about inappropriate use, product variability, and the absence of adequate regulatory oversight for pediatric sleep supplements.
The review reveals melatonin use among children has increased dramatically over the past decade, particularly in countries where it is sold as an over-the-counter supplement. Strong evidence supports its short-term effectiveness in children with neurodevelopmental disorders such as autism and attention-deficit hyperactivity disorder, where melatonin can reduce sleep-onset delay, increase total sleep time, and improve caregiver quality of life.
In contrast, evidence for typically developing children is sparse and heterogeneous. Most randomized trials in this group are short-term and involve older children or adolescents, limiting conclusions about younger age children where melatonin use is increasingly common. Long-term safety data are particularly lacking, with unresolved questions about potential effects on puberty, immune function, metabolism, and neurological development.
The review underscores significant safety concerns outside controlled clinical settings. Analyses of commercial melatonin products show a large discrepancy between labeled and actual melatonin content, with some products containing several times the stated dose or unintended compounds such as serotonin. Additionally, pediatric poison control data indicate a sharp rise in accidental melatonin ingestions, especially among young children, often linked to gummy formulations and improper storage. These findings collectively suggest that real-world risks may be substantially underestimated.
According to this review, melatonin should not be viewed as a harmless shortcut for childhood sleep problems. Although it plays a role in carefully selected cases, especially under medical supervision, it should never replace thorough sleep evaluation or behavioral interventions. The review emphasizes clinicians and caregivers should recognize melatonin as a biologically active hormone rather than a benign supplement. Without clearer evidence and stronger regulation, routine or unsupervised use may expose children to unnecessary risks while diverting attention from proven, non-pharmacological approaches to healthy sleep.
These findings have important implications for pediatric care, public health policy, and caregiver education. Behavioral sleep interventions—such as consistent routines, reduced screen exposure, and age-appropriate expectations—should remain the first-line treatment for childhood insomnia. When melatonin is considered, it should be used at the lowest effective dose, for the shortest duration possible, and only under medical supervision. The review also highlights the urgent need for better regulation of pediatric melatonin products, clearer labeling standards, and long-term clinical studies. Together, these measures could help ensure that children receive safe, effective, and evidence-based support for healthy sleep.
