Melatonin use in children calls for caution, experts say

Experts have warned that caution is necessary when providing melatonin to children, supporting this claim with data published in World Journal of Pediatrics on April 30, 2025.¹

A significant rise in melatonin use to help children sleep has been observed worldwide, despite a lack of clinical data about its long-term safety and efficacy in this population. Experts have also expressed concerns about inconsistent dosing in over-the-counter products, inappropriate use without medical guidance, and accidental ingestion.¹

“The impact of melatonin on pediatric populations has not yet been widely researched,” wrote investigators.²

Literature review highlights research gaps

The narrative review was conducted to summarize available literature about the safety and efficacy of melatonin use in pediatric patients, alongside potential pitfalls. Researchers compiled this information to help pediatric practitioners optimize evidence-based recommendations for children and their families.²

PubMed was searched for relevant articles using the search terms “melatonin,” “pediatrics,” and “child/adolescent.” The articles found from this method highlighted a significant increase in the past several decades.²

Most studies reporting safety and efficacy from melatonin use in children with insomnia included a pediatric population with neurodevelopmental disorders. However, little data was reported for typically developing children. Additionally, there were few prospective studies assessing long-term adverse effects.²

Concerns about melatonin use

Investigators also highlighted studies raising concerns about safety issues linked to accidental ingestions, alongside the variable content in over-the-counter melatonin. Based on these concerns and the lack of long-term efficacy and safety data, experts recommend melatonin be used with caution and under medical supervision in pediatric patients.²

Children and adolescents have experienced increased rates of sleep problems, which influence cognitive development, emotional regulation, and healthy conditions.¹ This has led to a sharp rise in melatonin use as parents search for quick and accessible options.

This increase has been attributed to the perception of melatonin as a safe alternative to prescription drugs, alongside its availability and child-friendly formulations. However, melatonin influences immune, metabolic, and reproductive systems alongside sleep–wake rhythms, and research remains uneven.¹

Data is also lacking about use in younger patients, primarily focusing on older children or adolescents. According to investigators, the long-term effects of melatonin on puberty, immune function, metabolism, and neurological development remain unknown. Based on these limitations, experts concluded real-world risks may be significantly underestimated.¹

Behavioral interventions recommended as first-line treatment

As an alternative, the authors recommended children receive behavioral sleep interventions as first-line treatment for childhood insomnia. These include consistent routines, reduced sleep exposure, and age-appropriate expectations.

Additionally, experts stressed that melatonin should only be given in the lowest effect dose for the shortest possible duration. Improved regulation of pediatric melatonin products, clearer labeling standards, and long-term clinical studies are also needed.¹

“Together, these measures could help ensure that children receive safe, effective, and evidence-based support for healthy sleep,” wrote investigators.

Evidence of long-term use in real-world practice

The significant prevalence of melatonin use in children has also been highlighted in a 2022 study by Swedish researchers, who found that many children who are prescribed melatonin continue to take it 3 years later and at larger doses.³ Of the pediatric population assessed, 65% had a neuropsychiatric diagnosis, while a sleep disorder was reported in 20%.

Investigators also noted significant rates of comorbidity and polypharmacy, with the latter having a prevalence of 46%. Continued use 3 years after the initial prescription was reported in 50% of male patients and 40% of female patients. This indicated long-term use of melatonin in pediatric patients.³

References

1. Why experts urge caution on melatonin use in children. Zhejiang University. January 16, 2026. Accessed January 29, 2026. https://www.eurekalert.org/news-releases/1112959
2. Owens, J. Melatonin use in the pediatric population: an evolving global concern. World J Pediatr. 2025;21:1081–1089. doi:10.1007/s12519-025-00896-5
3. Freedman M. Long-term melatonin use in children: Is it safe? Contemporary Pediatrics. September 21, 2022. Accessed January 29, 2026. https://www.contemporarypediatrics.com/view/long-term-melatonin-use-in-children-is-it-safe