A narrative review in the World Journal of Pediatrics says melatonin use among children and adolescents has climbed sharply—especially where the hormone is sold over the counter—while long-term data on safety and effectiveness, particularly for typically developing children, remain limited. The authors also highlight concerns about inconsistent supplement dosing and increasing accidental ingestions in young children.
Melatonin has become a common go-to sleep aid for children in many countries, helped by over-the-counter access in places such as the United States and its reputation among some families as a “natural” alternative to prescription medicines.
A narrative review by Boston Children’s Hospital sleep specialist Judith Owens, published in World Journal of Pediatrics, says pediatric use has risen substantially worldwide and argues that clinical practice has outpaced the evidence base—particularly on long-term outcomes. The review, “Melatonin use in the pediatric population: an evolving global concern,” was published online on April 30, 2025, and later appeared in the journal’s November 2025 issue (Vol. 21, No. 11, pp. 1081–1089).
The review concludes that the strongest evidence for melatonin’s benefit is in children with neurodevelopmental conditions and insomnia, including autism spectrum disorder and attention deficit hyperactivity disorder (ADHD). In those groups, studies suggest melatonin can shorten the time it takes to fall asleep and modestly extend total sleep time, with reported improvements in caregiver quality of life.
For typically developing children, the review says the evidence is thinner and less consistent. Many randomized trials have been short and have focused more on older children and adolescents, leaving less certainty about younger children even as use appears to be expanding.
The authors also point to unanswered questions about long-term safety. Because melatonin is a hormone with effects beyond sleep regulation, they note that it remains unclear whether extended use could affect puberty, immune function, metabolism, or neurological development.
Beyond pharmacology, the review raises product-safety and public-health concerns. It cites testing showing that the actual melatonin content of some commercially sold supplements can differ substantially from what labels claim, and that some products have contained unexpected compounds such as serotonin.
It also highlights the rise in accidental ingestions reported to poison control centers, particularly among younger children. U.S. Centers for Disease Control and Prevention surveillance has documented a sharp increase in pediatric melatonin ingestions over the past decade, and a separate CDC analysis found thousands of emergency department visits among infants and young children following unsupervised melatonin ingestion in recent years.
The review recommends that clinicians and caregivers treat melatonin as a biologically active hormone rather than a benign supplement. It urges that behavioral approaches—such as consistent bedtime routines, limiting screen exposure before bed, and setting age-appropriate sleep expectations—remain the first-line response to most childhood insomnia.
When melatonin is used, the authors recommend medical supervision, beginning with the lowest effective dose, limiting duration, and pairing treatment with an assessment of the child’s sleep habits and underlying contributors. They also call for stronger oversight and clearer labeling standards for products marketed for children, as well as more long-term clinical research to guide pediatric care.
