Rising Melatonin Use in Young Children Despite Limited Evidence: JAMA
A systematic review suggests that melatonin prescribing for young children has increased globally in recent years, even though robust evidence of efficacy is lacking for children with typical development. Some benefit was observed in improving sleep onset among children with neurological conditions, such as autism spectrum disorder. However, data on long-term outcomes, including effects on behavior and overall health, remain insufficient. The study was published in JAMA Network Open by Chelsea L. and colleagues.
Melatonin currently represents the leading cause of unsupervised medication exposure and overdose-related emergency department visits among young children aged 0 to 6 years. Whereas several previous studies have documented benefits of melatonin use in older children aged 7 to 18 years, especially those with neurologic conditions, evidence in younger children has thus far been limited. This gap is particularly concerning given the rapid rise in prescribing practices and increased availability of over-the-counter melatonin formulations. The primary objective of this systematic evidence review was to evaluate the long-term safety and effectiveness of exogenous melatonin use in young children.
The literature search in the present review covered nine databases, including Ovid MEDLINE, Embase, and Web of Science, in addition to two clinical trial registries. Other sources include existing systematic reviews and forward and backward citation tracking. Publication date range inclusion for eligible studies was from 2000 to February 26, 2025. Methodological quality was assessed using the Downs and Black Checklist to ensure structured evaluation of evidence strength.
A total of 19 articles were considered for the meta-analytic interpretation based on 12 observational studies, 6 experimental or intervention studies, plus 1 protocol. The observational studies covered a period of a median 9 years up to a maximum of 21 years in three studies, including registries from Nordic countries and Australians, plus poisoning databases from the US and Portugal. The experimental studies were conducted on 167 young children with neurologic disorders and had an average follow-up period of 12.7 weeks, with a minimum period of 2 weeks to a maximum period of 2 years.
This review of evidence makes it clear that, in spite of an increasing trend of melatonin prescriptions among young children globally, long-term efficacy and safety information, especially for developmentally normal children, has been absent. The results of this study underscore an immediate need to have measures in place aimed at lowering unwarranted melatonin exposure, unsupervised exposure in particular, among children.
Reference:
Kracht CL, Bolamperti G, Breeden R, et al. Melatonin Use in Young Children: A Systematic Review. JAMA Netw Open. 2026;9(1):e2551958. doi:10.1001/jamanetworkopen.2025.51958
