JAMA Netw Open

Melatonin use in children under age 6 is on the rise; generalizable efficacy data is limited

January 7, 2026

There’s a global rise in melatonin use—and for extended durations of use—in children under 6 years, despite limited efficacy data in children with typical neurological development. Pediatricians should focus on behavioral interventions in this age group (e.g., reducing nighttime screen time), according to authors of this systematic review.

• The review included 19 articles: 12 observational studies, 6 trials, and 1 protocol, published from 2000 to 2025. Observational data included Nordic, Australian registries and overdose/poisoning data from U.S. and Portugal. Trial data was focused on children (N=167) with neurological conditions (e.g., autism spectrum and related disorders) and had a mean duration of 12.7 weeks; methodological quality was variable.
• Efficacy. Short-term trials in specific populations (e.g., neurological conditions such as autism spectrum disorder) suggest that melatonin was generally effective for improving sleep onset, with few reported adverse events; however, data in children with typical neurological development and long-term data were lacking.
• Overdose. A rise in overdoses was reported in the U.S. from 2018 to 2022; authors speculated that pandemic-related disruptions to sleep routines and increasing availability of gummy formulations (47% of ingestions, in one study) could be potential factors. There was also evidence that children unintentionally consumed parents’ melatonin; adult use and the availability of higher-dose formulations are also on the rise.
• Nonpharmacologic alternatives. A UK audit of melatonin prescribing (N=4,151) revealed that that 32% of patients didn't receive a nonpharmacologic intervention before melatonin initiation; only 36% of clinicians documented quantification of melatonin's effectiveness in the first 3 months.

Source:

Kracht CL, et al. (2026, January 2). JAMA Netw Open. Melatonin Use in Young Children: A Systematic Review. https://pubmed.ncbi.nlm.nih.gov/41481289/