Update on Melatonin Use in the Pediatric Population

This newsletter is a contribution from

Rheanna Platt, MD, Assistant Professor in the Department of Psychiatry and Behavioral Sciences at Johns Hopkins School of Medicine and BHIPP Consultant.

Sleep problems are common in children and adolescents and increased during the pandemic (Sharma, et. al., 2021). So to, did use of melatonin as a sleep aid. While melatonin is considered a relatively safe short-term option for treating sleep disturbances, recent reports highlight potential concerns about use of melatonin in the pediatric population.

A report by the CDC in June 2022 found a significant increase in reported pediatric melatonin ingestions reported to poison control over the preceding decade; a 530% increase between 2012 and 2021, with the largest increase corresponding with the onset of the pandemic (Lelak, et. al., 2022). While most children in these reported ingestions were asymptomatic, serious outcomes did occur, particularly amongst children under the age of 5. More recently, a report in June 2023 found significant variability in the amount of melatonin contained in over-the-counter products; with the actual quantity of melatonin ranging from 74% to 347% of the labeled quantity (Cohen, et. al., 2023).

It should be noted that melatonin is classified as a dietary supplement, meaning that it is not regulated by the FDA the way that over-the-counter medications are. As a result, the American Academy of Sleep Medicine issued a health advisory about the use of melatonin in children and adolescents, which recommends that:

1. Melatonin be kept out of reach of children (as other medications are).

2. Parents discuss the decision to start melatonin (or other supplements) with a pediatric health care professional.

3. Parents should select a product with the USP verified mark, indicating that the product was produced in a facility following Good Manufacturing Practice standards.


As always, BHIPP is here to support you in addressing these concerns, the warmline remains open from 9am-5pm Monday through Friday at 855-MD-BHIPP (632-4477)


Sharma, M., Aggarwal, S., Madaan, P., Saini, L., & Bhutani, M. (2021). Impact of COVID-19 Pandemic on Sleep in Children and Adolescents: A Systematic Review and Meta-Analysis. Sleep Medicine, 84, 259–267. http://doi.org/10.1016/j.sleep.2021.06.002

Lelak, K., Vohra, V., Neuman, M.I., Toce, M.S., Sethuraman, U. (2022). Pediatric Melatonin Ingestions — United States, 2012–2021. MMWR Morbidity Mortality Weekly Report 2022; 71: 725–729. DOI: http://dx.doi.org/10.15585/mmwr.mm7122a1

Cohen, P. A., Avula, B., Wang, Y. H., Katragunta, K., & Khan, I. (2023). Quantity of Melatonin and CBD in Melatonin Gummies Sold in the US. JAMA329(16), 1401–1402. https://doi.org/10.1001/jama.2023.2296

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BHIPP is supported by funding from the Maryland Department of Health, Behavioral Health Administration and operates as a collaboration between the University of Maryland School of Medicine, the Johns Hopkins University School of Medicine, Salisbury University and Morgan State University.

BHIPP and this newsletter are also supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $433,296 with approximately 20% financed by non-governmental sources. The contents of this newsletter are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS or the U.S. Government. For more information, visit www.hrsa.gov.

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