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Melatonin Use in Young Children: A Systematic Review

Chelsea L Kracht1, Grace Bolamperti1, Rob Breeden1

  • 1University of Kansas Medical Center, Kansas City.

JAMA Network Open
|January 2, 2026
PubMed

Insights

Melatonin use in young children is rising, with limited data on effectiveness and safety for those without neurologic conditions. More research is needed to guide pediatricians on evidence-based melatonin prescribing practices.

Area of Science:

  • Pediatric pharmacology
  • Sleep medicine
  • Public health

Background:

  • Melatonin is a leading cause of unsupervised medication exposure and overdose in young children (0-6 years).
  • Existing research supports melatonin benefits in older children (7-18 years) with neurologic conditions, but data for younger children are scarce.
  • There's a global increase in melatonin prescriptions for young children, often without robust efficacy data.

Purpose of the Study:

  • To examine the long-term safety and effectiveness of melatonin use in young children (aged 0-6 years).
  • To synthesize evidence from observational and interventional studies on melatonin's impact on sleep and other outcomes in this age group.

Main Methods:

  • A comprehensive literature search was conducted across nine databases, two clinical trial registries, and existing systematic reviews up to February 26, 2025.
  • Included studies were observational and interventional, investigating exogenous melatonin for sleep in young children.
  • Methodological quality was assessed using the Downs and Black Checklist.

Main Results:

  • Nineteen articles (12 observational, 6 trials, 1 protocol) published between 2000-2025 were analyzed.
  • Observational data show increased prescribing, extended use, and overdoses, particularly in the last decade.
  • Trials indicate improved sleep onset in young children with neurologic conditions, with few adverse events, but lack long-term outcome data and efficacy information for typically developing children.

Conclusions:

  • There is a global rise in melatonin prescriptions for young children without sufficient efficacy data for those with typical development.
  • Strategies are needed to prevent and reduce melatonin use in young children.
  • Improved adherence to evidence-based practice standards by pediatricians is crucial.
Abstract

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