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Melatonin is used frequently to treat childhood insomnia.

Melatonin is often considered safe by caregivers, but should be given under medical supervision.

A major pediatric sleep professional organization has published guidelines for healthcare providers.

The International Pediatric Sleep Association (IPSA) includes members from multiple professional disciplines concerned with all aspects of sleep in children from birth through adolescence. In April, I attended their biennial meeting in Florence, Italy, to meet with colleagues and learn about the latest research and clinical practice in typically developing children and those with sleep disorders.

One presentation reported results of a 25-year study completed at the Cincinnati Children's Hospital of children diagnosed with chronic insomnia who had been treated with melatonin. Of 629 children in the study, 76.2 percent showed improvement in symptoms, with those with co-morbid neurological conditions less likely to show improvement, and those who had sleep disordered breathing or sleep movement disorders in addition to insomnia showing the most improvement. Adverse effects—e.g., morning sleepiness (5 percent) or nightmares (4 percent)—were infrequently observed. It must be emphasized that treatment was provided after a clinical diagnosis and supervision by medical personnel throughout the duration of treatment.

Melatonin is widely used worldwide, and medically supervised and unsupervised use is extensive. A recent survey of Italian pediatricians found that 97.4 percent used melatonin in their practice. Around 75 percent of them prescribed dosages of one milligram per day, with the most frequent use for decreasing the time needed to fall asleep. About a third indicated continued treatment for one month, and another third for two to three months.

Guidelines for Melatonin Use by Professionals

Last year, a set of guidelines for melatonin use in typically developing children by healthcare providers created by an IPSA task force was published in the journal Sleep Medicine. The recommendations are extensive, so I will summarize only a few, referring readers to the publication for the entire report.

While melatonin is often regarded as “natural” and thus safe, it is a medication and should be used only after a clinical diagnosis of insomnia and supervision by a healthcare provider.

Poor sleep hygiene (e.g., irregular or late bedtimes, use of social media, noise, light) should be ruled out as the primary cause of insomnia.

Melatonin should be considered only after behavioral treatments for insomnia have been tried without acceptable success.

Melatonin use should begin with the lowest possible dose with gradual (weekly) increases up to a maximum of 5 mg.

To avoid adverse effects from accidental or unsupervised overdose, caregivers should keep melatonin in child-proof containers.

Consumers should understand that, unlike in many countries, OTC melatonin is unregulated in the U.S., and there is no independent verification of ingredients or the accuracy of dosage.

There are limited data on long-term use (three to six months or longer), so there should be periodic checks for efficacy by a healthcare professional.

To conclude, while melatonin is used frequently with typically developing children as well as those with sleep disorders and has repeatedly been found to be effective in most cases, treatment should be supervised as closely as it is with prescription medications.

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Bruni, O., Breda, M., Nobili, L., Fietze, I., Capdevila, O. R. S., & Gronfier, C. (2024). European expert guidance on management of sleep onset insomnia and melatonin use in typically developing children. European Journal of Pediatrics, vol. 183(7), 2955-2964.

Owens, J., Simakajornboon, N., Kotagal, S., & Gringas, P. (2025). Melatonin use in typically developing children: International Pediatric Sleep Association expert consensus recommendations for healthcare providers. Sleep Medicine, vol. 128, 127-129. https://doi.org/10.1016/j.sleep.2025.02.002

Sitthikarnajkh, P., Simakajornboon, N, Nakamura, N., & Hossain, M. (April, 2026). The effect of melatonin usage on children with insomnia in clinical practice: A retrospective observational study. Presented at the Biennial Meeting of the International Pediatric Sleep Association. Florence, Italy.

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