By Judith A. Owens, MD, MPH

Anyone involved in sleep medicine and in treating children and adolescents with insomnia has inevitably encountered melatonin as the “drug of choice” for families over the past 10 years, often administered without input or supervision from a health care professional.The conundrum posed by the combination of the widespread over-the-counter availability of this hormone in the U.S., the lack of regulatory oversight by federal health agencies, the perception of caregivers of melatonin as alternatively “safe” and “natural” (often bolstered by social media and commercial marketing) versus “a medication with unknown long-term side effects including a potential impact on pubertal development,” and the overall dearth of pediatric clinical trials of melatonin (especially in typically developing children) has left families, health care professionals (including general pediatricians), and the general public at a loss for guidance in making appropriate and safe management decisions.

As experts in diagnosing and treating insomnia across the lifespan, it then is our responsibility within the sleep medicine community to educate ourselves, our medical colleagues, and our patients and families about the pros and cons of melatonin use in children and to advocate for improved regulation and surveillance at the federal level (i.e., mirroring the degree of oversight that exists in most countries around the world).

In the spirit of evidence-based information-sharing, first, the bad news:

  1. The U.S. FDA has classified exogenous melatonin as a “dietary supplement,” a designation that essentially waives any requirements for clinical trial efficacy and safety data and that makes the assumption that a substance is “safe until proven otherwise.”
  2. A recent FDA-sponsored study found the variability in actual content (measured by chromatography) of 110 over-the-counter melatonin supplements marketed specifically for children ranged from 0% to 667% of the label declaration.
  3. Pediatric melatonin use in the U.S. has risen at an exponential rate over the past several decades. A recent study of caregivers in the U.S. revealed that among children aged 5 to 9 years, 18.5% had been given melatonin in the previous 30 days, and nearly 6% of preschoolers aged 1 to 4 years had taken melatonin in the previous month. In comparison, only 1.3% of U.S. caregivers reported giving their children melatonin overall in 2017-18.
  4. Despite clear evidence that behavioral interventions are the first-line management option for insomnia in children as they are in adults, caregivers may choose inappropriate and/or unproven indications (such as “reducing the number of night awakenings” and promoting “more restful and better sleep”) in very young children without clear insomnia symptoms.
  5. Mixed messages and even dangerous practices are advocated on social media, such as giving children in daycare melatonin for naps or mixing melatonin “gummies” in with fruit snacks.
  6. Caregiver reliance on such dubious sources of information without consultation from their child’s doctor circumvents the opportunity to have a through clinical evaluation for alternative etiologies of insomnia symptoms (e.g., restless legs syndrome or circadian rhythm disorders).
  7. Perhaps most alarmingly, accidental ingestions of melatonin in children reported to poison control centers increased by 530% between 2012 and 2021, and pediatric ingestions resulting in emergency department visits increased between 2009 and 2020 by 421% for melatonin while declining for many commonly ingested prescription drugs.

On the other hand, the good news is that overall published pediatric clinical trials have shown a robust effect on reducing sleep onset latency and increasing total sleep time with immediate-release melatonin and reducing night awakenings with an extended-release formulation (not currently available in the U.S.). These trials were largely conducted in children with autism and other neurodevelopmental disorders, but the fewer number of studies in typically developing children had similar positive results. Short-term side effects were generally mild and well-tolerated; longer term adverse events (up to four years follow-up and including small studies examining pubertal development) have not been clearly identified overall but remain of potential concern, as melatonin has extensive effects on multiple organ systems including immune function, bone growth, cardiovascular function, and regulation of the gut microbiome. As a result, the full array of potential side effects and drug-drug interactions in the developing child, including the impact of genetic polymorphisms such as CYP 1A2 (postulated to occur in 5% to 10% of the population) on increased or decreased melatonin levels have yet to be fully examined.

Thus, melatonin use in pediatrics remains both an evolving story and a cautionary tale. Relatively few recommendations currently exist for the various stakeholders, in part due to the overall lack of randomized clinical trials. However, this does not mean that melatonin should never be used in children while awaiting more data — after all, sleep is critical for children’s health and development, and melatonin usage has the potential to ensure that they obtain sufficient and good-quality sleep.

To address this gap, a task force of the International Pediatric Sleep Association has developed and published a set of expert consensus-based recommendations on the use of melatonin in both neurodiverse and typically developing children. However, the present knowledge gaps and the critical need to promote optimal sleep and health outcomes for children also represent a “call to action” for our field, including researchers, clinicians, and public policy advocates alike. A fundamental piece of that mission is to promote “cross-fertilization” of evidence-based information and recommendations regarding melatonin through collaboration with pediatric professional organizations such as the American Academy of Pediatrics representing “front-line” clinicians and publication of pediatric sleep research in journals readily accessible to these stakeholders.

Dr. Judith Owens is a professor of neurology at Harvard Medical School and previously led the pediatric sleep programs at Children’s National Medical Center in Washington, D.C., and Boston Children’s Hospital. She is a past president of the International Pediatric Sleep Association, recipient of the World Sleep Society’s 2025 Distinguished Service Award, and the author of numerous peer-reviewed research publications, chapters, and books on pediatric sleep.

This article appeared in volume 11, issue 1 of Montage magazine.