Melatonin Use in Young Children: A Systematic Review
Abstract
IMPORTANCE: Melatonin is the leading cause of unsupervised medication exposure and overdose in emergency departments for young children (aged 0-6 years). Existing literature has documented the benefits of melatonin in older children (aged 7-18 years) with neurologic conditions but has yet to examine young children.
OBJECTIVE: To examine the long-term outcomes (safety and effectiveness) associated with melatonin use in young children.
EVIDENCE REVIEW: Nine databases, including Ovid MEDLINE, Embase, and Web of Science; 2 clinical trial registries; existing subject matter systematic reviews; and forward and backward citation of included articles were reviewed from inception to February 26, 2025, to identify observational and interventional studies that investigated the safety and effectiveness of exogenous melatonin on sleep in young children. Methodological quality was assessed using the Downs and Black Checklist.
FINDINGS: Nineteen articles representing 12 observational studies, 6 experimental studies (hereafter, trials), and 1 protocol published between 2000 and 2025 were included. The observational studies reported on 9 years (range, 3-21 years) of data from Nordic or Australian registries or poisoning data from the US and Portugal. The trials included 167 young children with neurologic conditions and lasted a mean of 12.7 weeks (range, 2 weeks to 2 years). For safety, observational studies documented rises in prescribing practices, extended use, and overdoses, especially…
How strong is the evidence?
Evidence Hub reads this as a systematic review, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 167 participants or records.
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