Melatonin gummy labels often inaccurate. But that’s not why thousands of kids have been hospitalized after accidental overdoses.
Melatonin. It’s a hormone that our bodies make and release when it’s bedtime. For people having trouble getting to sleep, taking some supplemental melatonin has been shown (in randomized controlled clinical trials) to help.
Children and adolescents have insomnia too. But because melatonin is sold over-the-counter as a dietary supplement rather than a drug, there is far less quality control. If you read the dose of a bottle of ibuprofen, it’s going to be accurate. Not so of dietary supplements.
Regardless, melatonin use is up, and so are pediatric hospitalizations resulting from accidental overdoses. From 2012 to 2021, pediatric melatonin overdoses were responsible for 4,097 hospitalizations and 287 intensive care unit admissions, with calls to poison control centers going up 530% during that time. Two pediatric deaths due to melatonin overdose occurred during that decade.
Could the overdoses be due to inaccurate dosing information? Maybe. First, I’ll summarize some new research on the topic. Then I’ll tell you what I believe the real problem is.
New data on melatonin gummy labels.
Melatonin comes in many forms. Gummies are increasingly popular, with dozens of brands on the market. New research published in the Journal of the American Medical Association shows that melatonin gummy dosing labels are impressively unreliable. The upshot is that people taking melatonin have no idea what dose they’re getting most of the time.
Researchers measured the contents of 25 products and found 88% of them had inaccurate dosing labels (defined as not being within 10% of the labeled quantity). The range was alarming, from 74% of the stated dose to 347%.
For kids who accidentally ingest an adult dose of at least some of these gummy melatonin products, the result could be exposure to levels between 40- to 130-times higher than their normal ranges at night.
The study missed the big picture on what’s driving poisonings.
The JAMA study is more-or-less presented as a cautionary tale about bad labelling of substances that have pharmacologic effects. And I do believe that officials should reconsider how melatonin is regulated (i.e., it’s a drug, and should be treated as such).
But this study missed the bigger problem. The authors concluded that “clinicians should advise parents that pediatric use of melatonin gummies may result in ingestion of unpredictable quantities of melatonin.”
That’s true. But that’s not the right conclusion.
The main problem is not that parents are messing up the dosing when trying to medicate their kids. The real problem is that melatonin is being marketed and sold as gummies which kids see and promptly want to eat.
I’ve been a doctor and a parent long enough to know the following:
Kid sees gummy.
Kid eats gummy.
Kid does not read label that says “this is not candy.”
Kid eats more gummies.
Kids are not accidentally eating too much melatonin gummies because they are sleepy. They are accidentally eating too much melatonin because they come in the shape of something that looks like a tasty treat.
The correct conclusion of the JAMA and CDC data is that parents should keep drugs that look like candy in places that young children can’t access.
How do I know this is the actual correct message? Because the CDC’s data tell us that 84% of poison control calls for kids who ingested too much melatonin was for children ages 5 and under, 11% were for kids ages 6-12, and just 5% for adolescents ages 13-19. So, for the most part, these were not cases of parents getting the melatonin doses wrong for wee-kids with insomnia. These were cases of tiny people who confused drugs for snacks.
Look at the numbers. According to the JAMA study, melatonin gummy servings may contain up to 3.47 times (347%) the dose of the compound as the labels claim. Even if the labels on these products were accurate, kids could easily be getting 11.5- to 37.5-times more melatonin than their normal nighttime levels by partaking of these products. And that’s if they ate just one or two gummies. Unlikely! See above, under “stuff kids are and are not liable to do.”
No, my friends. The real reason behind the rise in pediatric melatonin poisonings is not the slipshod dosing information on the melatonin packages—though that’s bad. The problem is that dietary supplement companies are shoving melatonin into objects that look like are candy.
Hi Dr. Faust. I don’t know how often you confront doctors with different takes than the mainstream (like Vinay Prasad). If you get a chance I would value your opinion as to whether I’m out of bounds with my take on his recent post:
https://substack.com/profile/24673649-ryan-mccormick-md/note/c-15404159?utm_source=notes-share-action