Pediatric melatonin use increased during the pandemic, and melatonin-related emergency room visits increased along with it. Now, a new study suggests that incorrectly labeled supplements and inconsistent melatonin potencies may be to blame—and researchers are urging caution around the popular sleep aid.

Cohen PA, Avula B, Wang Y-H, Katragunta K, Khan I. Quantity of melatonin and CBD in Melatonin Gummies sold in the US. JAMA. 2023;329(16):1401. doi:10.1001/jama.2023.2296

 

“I would not trust that a quantity of melatonin listed on a melatonin gummy label is accurate given our results,” says Pieter Cohen, MD, associate professor of medicine at Cambridge Health Alliance and lead author of the study. 

From 2020 to 2021, US Poison Control Centers received a 530% increase in calls for pediatric melatonin ingestions, according to the study. In addition, these calls were associated with tens of thousands (27,795) of emergency department and clinic visits, thousands (4,097) of hospitalizations, hundreds (287) of intensive care unit (ICU) admissions, and two deaths, according to the study.

Cohen PA, Avula B, Wang Y-H, Katragunta K, Khan I. Quantity of melatonin and CBD in Melatonin Gummies sold in the US. JAMA. 2023;329(16):1401. doi:10.1001/jama.2023.2296

 

These numbers aren’t just on paper. Daniel Ganjian, MD, a pediatrician at Providence Saint John’s Health Center in Santa Monica, CA, says he’s noticed a recent increase in melatonin overdose calls in the practice, most of which appear to result from accidental ingestion.

“Almost all the homes have some melatonin in it,” adds Ganjian. “Kids go into a mom or grandmother's jar of melatonin, and they eat it. [They think,] ‘Oh, this is candy.’”

Some pediatric patients take melatonin on purpose, too. (Parents may give melatonin to help their children fall asleep.) With that in mind, the study heightens the importance of cautiously approaching supplements, which most pediatricians should already be doing, Ganjian says. 

“Any time we give supplements, we’re always wary,” Ganjian adds. “This makes things even more wary [because] now that you don't even know how much you're giving a child.”

 

What the melatonin study found

 

To conduct the study, Cohen and the team evaluated 25 unique brands of melatonin gummies that clearly stated “melatonin” on the label and were available for purchase. They reconstructed these gummies in a lab setting to dissect their ingredients and compare the actual make-up to that displayed on the supplements’ labels.

Their investigation revealed wide ranges of melatonin composition in the different brands—spanning from a high of 13.1 mg per serving to one low of 0, i.e., no detectable melatonin at all.

It also revealed wide ranges in how closely the gummies’ true melatonin composition matched its label. A majority of the products studied (22 brands) were inaccurately labeled, and only three products contained melatonin levels within 10% proximity to the labeled quantity. When taking out the ‘no melatonin’ outlier, “the actual quantity of melatonin ranged from 74% to 347% of the labeled quantity,” the researchers wrote.

Going forward, Cohen said he and his team hope to pursue answers to study answers to further questions about melatonin use and safety:

• Guidance around the safety and security of melatonin gummies, particularly in households with young children.

• The most common types of melatonin gummies are currently used for children.

• The potency of melatonin tablets.

 

How can physicians guide melatonin recommendations?

 

Melatonin is a supplement and is not currently regulated by the Food and Drug Administration. The new findings place an additional responsibility on physicians to be careful about if and to what extent they recommend pediatric patients take melatonin.

“When we decide to recommend melatonin, we should specify precisely what dose we recommend,” says Cohen. “Then, we need to help patients find melatonin products that are properly labeled.”

Based on his own experience in pediatrics, Ganjian recommends doctors first encourage sleep hygiene techniques, like recommending the patient sleep in a calming environment, turning off the lights at a consistent time, and keeping distractions (or the family dog) out of the bed, before turning to a supplement like melatonin. After that, if recommending melatonin to a pediatric patient, he emphasizes the importance of starting with a small dose and titrating up if needed.

“In general, the model for children is: the less, the better,” says Ganjian. “If things are not needed, don't give it.”