A new report from the Centers for Disease Control and Prevention (CDC) has documented a steep rise in unsupervised melatonin exposures among infants and young children that resulted in visits to emergency rooms. The report estimates almost 11,000 such cases took place from 2019 to 2022. 

The report was published yesterday as part of the CDC’s Morbidity and Mortality Weekly Report.   

The report noted that overall melatonin usage has increased dramatically in the past two decades, with about 2.1% of U.S. adults reporting using products containing the ingredient in the 2017-2018 time frame. That’s a fivefold increase from the 0.4% of U.S. adults who said they used melatonin in 1999-2000.

The reports of exposures to children less than 5 years of age have risen, too, which is to be expected to some degree. The more households that have melatonin products on the shelf means more opportunities for children to access the products when their caregivers are distracted. 

The report’s authors used data culled from 295 individual case reports to estimate overall numbers. By applying a statistical technique, the report’s authors concluded that there were 10,930 ED visits in 2019 to 2022 associated with unsupervised melatonin ingestion. 

This is the second time in less than a year that a report in a major medical information outlet has sounded an alarm about melatonin exposures among young children. In May 2023 prominent industry critic Pieter Cohen, M.D., along with some collaborators published a paper in the Journal of the American Medical Association on the melatonin content of a number of popular gummies. The researchers found a wide range of melatonin content in the gummies, with 22 of the 25 products tested failing to meet label claim. Some of them contained large overages. 

Related:Melatonin gummies deemed 'unsafe' but are they really? — analysis

Rise in flavored solid dosage forms 

What has changed in the intervening decades is the rise in flavored delivery formats for melatonin, which is a naturally occurring hormone that is used as a dietary supplement ingredient in products aimed at healthy sleep and mood support.  

More than a decade ago FDA censured a company that was putting melatonin into brownies. The agency concluded that melatonin is not a suitable ingredient for use in foods and that the products, dubbed “Lazy Cakes” when first put on the market, were foods, even though the product developers were trying to make the case that they were being marketed as supplements. Part of the concern at the time, too, was that the brownies could pose a safety risk because they would be too attractive to small children. 

Related:CRN questions sources cited in JAMA review of melatonin use

More than 95% of the ER visits were associated with a solid dosage form. Almost half of those (47%) were associated specifically with gummies. The rest were an unspecified solid dosage form (gummies or tablets). 

The authors noted that very few of the ER visits resulted in hospitalizations.  

Steve Mister, president and CEO of the Council for Responsible Nutrition, told the Wall Street Journal that exposure should not be automatically equated with harm. 

“A parent justifiably panics when they see their kid has gotten into something they shouldn’t be in,” Mister was quoted as saying. “But that doesn’t mean the product is causing any significant harm to the kids.” 

Child-resistant packaging is not required on melatonin products, though it may be instituted on a voluntary basis, and the authors did recommend that parents with young children might consider buying products with that kind of packaging. 

“The continued need to educate parents and other caregivers about the importance of keeping all medications and supplements (including gummies) out of children’s reach and sight,” the report concluded.