Melatonin Use in Young Children: A Systematic Review

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.