Melatonin has become one of the most commonly used sleep aids for children, often viewed by families as a natural and low-risk solution for bedtime struggles. A new medical review, however, suggests that its growing use has moved faster than the science supporting long-term safety and appropriate use in pediatrics.
The review was published in the World Journal of Pediatrics and examines the expanding global use of melatonin among children and adolescents. Researchers evaluated evidence on effectiveness, safety, product quality and real-world use patterns, with particular attention to where data are strong and where important gaps remain.
The authors note that melatonin is a hormone that helps regulate circadian rhythms, but it also plays roles in immune, metabolic and reproductive systems. While this does not mean melatonin is inherently unsafe, it does underscore why assumptions about long-term safety in children require careful study.
The strongest evidence for melatonin use was found among children with neurodevelopmental conditions such as autism spectrum disorder and attention-deficit hyperactivity disorder. In these groups, short-term studies show melatonin can reduce the time it takes to fall asleep, increase total sleep duration and ease stress for caregivers.
By contrast, evidence for typically developing children is limited and inconsistent. Most studies in this population are short-term, focus on older children or adolescents and vary widely in dosing and study design. As a result, researchers say it remains difficult to draw firm conclusions about safety and effectiveness, especially for younger children who are increasingly using melatonin products.
The review also highlights concerns related to how melatonin is used outside clinical settings. Analyses of over-the-counter products have found large differences between labeled and actual melatonin content, with some products containing substantially higher doses than stated. In some cases, additional compounds such as serotonin have been detected.
Pediatric poison control data further raise concerns. Reports of accidental melatonin ingestion among young children have increased sharply in recent years, often involving gummy formulations that resemble candy and are stored within reach.
Taken together, the authors argue that melatonin should not be treated as a harmless shortcut for childhood sleep problems. While it may have a role in carefully selected cases, particularly under medical supervision, it should not replace thorough sleep evaluation or behavioral approaches that address routines, screen exposure and age-appropriate sleep expectations.
The review emphasizes that behavioral sleep interventions remain the first-line approach for childhood insomnia. When melatonin is considered, the authors recommend using the lowest effective dose, limiting duration and involving a health care professional to guide use and monitor potential side effects.
The authors also call for stronger regulation of pediatric melatonin products, clearer labeling standards and more long-term research to better understand how melatonin affects growth and development over time.
The authors report no funding for this review.