Thousands of Children Have Been Treated in the E.R. After Ingesting Melatonin While Unsupervised

More than half of the nearly 11,000 accidental ingestions from 2019 to 2022 involved kids between the ages of 3 and 5, according to a new CDC report

Around 11,000 children were taken to the emergency room between 2019 and 2022 after ingesting melatonin products while unsupervised, according to a new report from the U.S. Centers for Disease Control and Prevention (CDC).

Melatonin is a naturally-occurring hormone that regulates the body's sleep-wake cycle. The use of melatonin products — which are sold over the counter, often in the form of flavored chews or gummies — has become increasingly popular among U.S. adults in recent years.

Melatonin is a supplement and not currently regulated by the U.S. Food and Drug Administration.

Related: More Americans Are Taking Melatonin to Sleep, Possibly at Dangerously High Amounts, Study Finds

For the report, which was published on Thursday, researchers from both the CDC and the U.S. Consumer Product Safety Commission identified and studied cases of ER visits made between 2019 and 2022 for unsupervised melatonin ingestion involving children ages 5 or younger.

Based on 295 identified cases, an estimated 10,930 emergency room visits occurred during that time period, accounting for 7.1% of all ER visits for unsupervised medication exposures by infants and children. About half of the accidental ingestions involved children ages 3 to 5, and most of the cases (90.2%) did not involve any other medications.

The majority of the accidental ingestions — about 93.5% — did not result in hospitalization.

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According to the report, at least half of the ER visits for melatonin ingestions involved flavored products, such as gummies or chewable tablets, that "might appeal to young children." The authors noted that melatonin does not require child-resistant packaging, but such packaging can be voluntarily implemented.

Related: Pediatric Hospitalizations Due to Accidental Melatonin Overdoses Spiked in Last Decade, CDC Says

Among the ER visits where the container type was documented, approximately three-quarters involved bottles, "suggesting that infants and children opened bottles or that bottles were not properly closed," the report stated.

The researchers noted that this new study underscores "the importance of educating parents and other caregivers about keeping all medications and supplements (including gummies) out of children’s reach and sight."

A study published in the journal JAMA in 2022 found that, over the course of a decade, Americans more than doubled the amount of melatonin they were taking on a regular basis.

The study's authors noted that the spike in usage is concerning because bottles of melatonin may have far higher amounts of the drug than what the label indicates.

"These estimates may raise safety concerns, especially given that the actual content of melatonin in marketed supplements may be up to 478% higher than the labeled content," the researchers wrote.

They also warned that there is not enough research yet about the long-term use of melatonin, stating: "Although melatonin is generally regarded as safe, adverse effects have been reported, and data on long-term use and high-dose use are scarce."

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