These findings suggest a global rise in prescriptions without efficacy data on use in children with typical development, underscoring the need to identify strategies to prevent and reduce melatonin use in young children, as well as to improve adherence by pediatricians to evidence-based practice standards.
Melatonin is the leading cause of unsupervised medication exposure and overdose in emergency departments for young children aged 0-6 years.
The systematic review identified 19 articles representing 12 observational studies, 6 experimental trials, and 1 protocol published between 2000 and 2025.
Observational studies documented a global rise in melatonin prescribing practices and extended use in young children, especially over the past decade.
Clinical trials provided evidence for improved sleep onset in young children with neurologic conditions such as autism spectrum disorder, with few adverse events reported.
No efficacy data were available for melatonin use in young children with typical development.
Data regarding long-term outcomes for behaviors and health beyond sleep onset were absent across the included studies.
The overall methodological quality of included studies was mixed, with more than half rated as poor or fair.
The review concludes there is a need to identify strategies to prevent and reduce melatonin use in young children and to improve adherence by pediatricians to evidence-based practice standards.
This research examined what is known about melatonin use in very young children (ages 0 to 6 years) by systematically reviewing nearly two decades of published studies. The researchers found that melatonin is now the leading cause of medication overdose in emergency rooms for this age group, and that prescriptions for melatonin have been rising sharply over the past decade. When they looked at clinical trials, they found that melatonin did help young children with neurological conditions like autism fall asleep more quickly, with few side effects — but all of this evidence came from children with diagnosed conditions, and the trials were generally short (averaging about 3 months). A critical gap the researchers identified is that there is no scientific evidence showing melatonin is effective or safe for typically developing young children who simply have trouble sleeping. Despite this, melatonin is being prescribed and used widely in this age group. The studies reviewed were also generally of modest methodological quality, meaning the overall evidence base is not strong. There were no data on what happens to children's health or behavior over the long term when they take melatonin regularly at this young age. This research suggests that the rapid increase in melatonin use in very young children is happening without the scientific backing to justify it for most of the children receiving it. The authors call for efforts to reduce unnecessary melatonin use in this population and for doctors to follow evidence-based guidelines more carefully. For parents and caregivers, the study highlights that while melatonin may help some children with specific neurological conditions under medical supervision, its broader use in young children lacks a solid evidence base and carries documented risks including accidental overdose.
Kracht C, Bolamperti G, Breeden R, Crocker M, Christifano D, Gibler R, et al.. (2026). Melatonin Use in Young Children: A Systematic Review.. JAMA network open. https://doi.org/10.1001/jamanetworkopen.2025.51958