Nearly one in five school-aged children and preteens now take melatonin for sleep, and some parents routinely give the hormone to preschoolers, according to new research from the University of Colorado Boulder published Nov. 13 in JAMA Pediatrics.
This concerns the authors, who note that safety and efficacy data surrounding the products are slim, such dietary supplements lack full regulation by the Food and Drug Administration.
"We hope this paper raises awareness for parents and clinicians, and sounds the alarm for the scientific community," said lead author Lauren Hartstein, PhD, a postdoctoral fellow in the Sleep and Development Lab at CU Boulder. "We are not saying that melatonin is necessarily harmful to children. But much more research needs to be done before we can state with confidence that it is safe for kids to be taking long-term."
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Melatonin is produced naturally in the pineal gland to signal the body that it is time to sleep and regulate its circadian rhythm—the physiological cycle over a 24-hour period.
In many countries, the hormone is classified as a drug and available by prescription only.
In the United States, however, chemically synthesized or animal-derived melatonin is available over the counter as a dietary supplement, and increasingly available in child-friendly gummies.
"All of a sudden, in 2022, we started noticing a lot of parents telling us that their healthy child was regularly taking melatonin," said Hartstein, who studies how environmental cues, including light at night, impact children's sleep quality and melatonin production.
During 2017-18, only about 1.3% of U.S. parents reported that their children used melatonin.
To get a sense of the current prevalence of use, Hartstein and colleagues surveyed about 1,000 parents in the first half of 2023.
Among children ages 5 to 9, 18.5% surveyed had been given melatonin in the previous 30 days. For preteens ages 10 to 13, that number rose to 19.4%. Nearly 6% of preschoolers ages 1 to 4 had used melatonin in the previous month.
