Pediatric medicine specialists are calling for more research into the effects of melatonin supplements for children because one in five parents give their school-aged or adolescent children the sleep aid routinely.
Before the COVID-19 pandemic, less than 2% of parents gave their children melatonin, a naturally occurring hormone that prepares the body for sleep.
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Researchers with the University of Colorado, Boulder, released a study in JAMA Pediatrics this week that found 18.5% of children aged 5 to 9 had been given melatonin in the past 30 days. Over 19% of youths aged 10 to 13 had been given the supplement within the past month, while 6% of children between the ages of 1 and 4 had been given the supplement.
“All of a sudden, in 2022, we started noticing a lot of parents telling us that their healthy child was regularly taking melatonin,” said lead author Lauren Hartstein, a postdoctoral fellow at the Sleep Development Lab at CU Boulder.
The duration of use also worried researchers. Based on the findings, the typical parent in the study has been giving their preschooler melatonin for about a year, whereas grade school and adolescent youth have been taking the supplement for between 18 and 21 months.
“We are not saying that melatonin is necessarily harmful to children," Hartstein said in a statement. "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.”
Another concern of Hartstein and her colleagues is the lack of regulation on the dosages of melatonin, saying that "parents may not actually know what they are giving to their children."
A study published in April analyzed the contents of 25 melatonin gummy products and found that 22 contained different amounts of melatonin than indicated on the packaging. One had more than three times the amount advertised by the manufacturer.
Because melatonin is classified as a dietary supplement under the category of food, the Food and Drug Administration does not regulate the dosage or advertisement of melatonin like it would medications.
"It’s important to underscore that under current law, the FDA does not have the authority to approve dietary supplements before they are marketed, and firms have the primary responsibility to make sure their products are not adulterated or misbranded before they are distributed," an FDA spokesperson told the Washington Examiner.
The FDA spokesperson also said that although the agency takes seriously product quality concerns, it does not comment on specific studies.
Between 2012 and 2021, calls to poison control centers for melatonin ingestion increased by 530%, with the largest group affected being children under 5.
Hospitalizations and serious outcomes from melatonin poisoning have also increased over the past 10 years. The majority of hospitalizations involved teenagers who intentionally overdose on the supplement.
Melatonin has had positive outcomes for children with various chronic conditions, such as asthma, ADHS, or autism spectrum disorder.
Hartstein's co-author, psychologist and pediatric sleep specialist Julie Boergers, said that although melatonin can be fruitful in these circumstances "it is almost never a first-line treatment."
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The National Center for Complementary and Integrative Health, part of the National Institutes of Health, recommends that parents speak with their children's healthcare providers before using the sleep aid.
"There are no overall guidelines on the best approach to improving sleep in children," the center says. "However, guidelines for specific conditions recommend behavioral treatments, such as good bedtime habits and parent education, as an initial treatment that may be supplemented with medicines."