The vast majority of melatonin gummies sold in the US may contain up to 347% more melatonin than is listed on the label, new research shows.
Investigators found that consuming some products as directed could expose consumers, including children, to doses that are 40 to 130 times greater than what's recommended.
"The results were quite shocking," lead researcher Pieter Cohen, MD, with Harvard Medical School and Cambridge Health Alliance, Somerville, Massachusetts, told Medscape Medical News.
"Melatonin gummies contained up to 347% more melatonin than what was listed on the label, and some products also contained cannabidiol (CBD); in one brand of melatonin gummies, there was zero melatonin, just CBD," Cohen said.
The study was published online April 25 in JAMA.
530% Jump in Pediatric Hospitalizations
Melatonin products are not approved by the US Food and Drug Administration but are sold over the counter or online.
As previously reported by Medscape Medical News, the use of melatonin has increased over the past two decades among people of all ages.
With increased use has come a spike in reports of melatonin overdose, calls to poison control centers, and related emergency department visits for children.
Federal data show the number of US children who unintentionally ingested melatonin supplements jumped 530% from 2012 to 2021. More than 4000 of the reported ingestions led to a hospital stay; 287 children required intensive care, and two children died.
It was unclear why melatonin supplements were causing these harms, which led Cohen's team to analyze 25 unique brands of "melatonin" gummies purchased online.
One product didn't contain any melatonin but did contain 31.3 mg of CBD.
In the remaining products, the quantity of melatonin ranged from 1.3 mg to 13.1 mg per serving. The actual quantity of melatonin ranged from 74% to 347% of the labeled quantity, the researchers found.
They note that for a young adult who takes as little as 0.1 mg to 0.3 mg of melatonin, plasma concentrations can increase into the normal night-time range.
Of the 25 products (88%) analyzed, 22 were inaccurately labeled, and only three (12%) contained a quantity of melatonin that was within 10% (plus or minus) of the declared quantity.
Five products listed CBD as an ingredient. The listed quantity ranged from 10.6 mg to 31.3 mg per serving, although the actual quantity of CBD ranged from 104% to 118% of the labeled quantity.
Inquire About Use in Kids
A limitation of the study is that only one sample of each brand was analyzed, and only gummies were analyzed. It is not known whether the results are generalizable to melatonin products sold as tablets and capsules in the US or whether the quantity of melatonin within an individual brand may vary from batch to batch.
A recent study from Canada showed similar results. In an analysis of 16 Canadian melatonin brands, the actual dose of melatonin ranged from 17% to 478% of the declared quantity.
It's estimated that more than 1% of all US children use melatonin supplements, most commonly for sleep, stress, and relaxation.
"Given new research as to the excessive quantities of melatonin in gummies, caution should be used if considering their use," said Cohen.
"It's important to inquire about melatonin use when caring for children, particularly when parents express concerns about their child's sleep," he added.
As reported by Medscape Medical News, the American Academy of Sleep Medicine recently issued a health advisory encouraging parents to talk to a healthcare professional before giving melatonin or any supplement to children.
Children Don't Need Melatonin
Commenting on the study for Medscape Medical News, Michael Breus, PhD, clinical psychologist and founder of TheSleepDoctor.com, agreed that analyzing only one sample of each brand is a key limitation "because supplements are made in batches, and gummies in particular are difficult to distribute the active ingredient evenly.
"But even with that being said, 88% of them were labeled incorrectly, so even if there were a few single-sample issues, I kind of doubt its all of them," Breus said.
"Kids as a general rule do not need melatonin. Their brains make almost four times the necessary amount already. If you start giving kids pills to help them sleep, then they start to have a pill problem, causing another issue," Breus added.
"Most children's falling asleep and staying sleep issues can be treated with behavioral measures like cognitive-behavioral therapy for insomnia," he said.
The study had no specific funding. Cohen has received research support
from Consumers Union and PEW Charitable Trusts and royalties from UptoDate. Breus has disclosed no relevant financial relationships.
JAMA. Published online April 25, 2023. Full text
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Cite this: Majority of Melatonin Gummies in the US Inaccurately Labeled - Medscape - Apr 26, 2023.