New Study Finds Melatonin Gummies Don't Always Contain What You Think

While melatonin is increasingly popular, too much of it can pose potentially serious medical risks. 

In 2022, a group of toxicologists published an analysis of calls to the U.S. poison control centers related to pediatric melatonin ingestions. Between 2012 and 2021, there had been more than 250,000 calls regarding melatonin ingestions in children, with a 530 percent increase over the 10-year period. Of these calls, almost 30,000 children required medical evaluation, 4,097 were hospitalized, and two died. 

Though many of those cases likely involved children ingesting far more than the recommended dose, it’s clear that too much melatonin can cause sleepiness, headache, nausea, and agitation, according to the National Capital Poison Center.

In the new study, products that were found to contain no or very little melatonin are unlikely to assist with sleep, Cohen says, which suggests that some people are paying for something that is essentially an expensive gummy candy. But the primary concern is the gummies that contain far more melatonin than expected, he says, which represent a “lack of quality control” that could be dangerous. 

It’s not yet known whether non-gummy melatonin supplements are any more reliable, at least in the U.S. But one study from 2017 found that melatonin content in a variety of Canadian supplements—which are regulated more strictly than in the U.S.—was off by at least 10 percent from the amount listed on the label. Cohen suspects U.S. supplements are not any better. 

Treat melatonin supplements like prescription drugs, in terms of the care you take with storing and taking them. 

“If you are using melatonin and you have kids at home, make sure it’s secured like a prescription medication,” Cohen says. Don’t keep melatonin—especially gummies, which a child could confuse for candy—easily accessible. 

It’s also a good idea to consult with your doctor (or your child’s pediatrician) before you start taking melatonin or giving it to your child. The provider can address potential concerns about sleeping—which might be better treated with other interventions—and recommend the appropriate dosage if melatonin makes sense for you. 

Currently, the FDA does not test supplements for purity or safety. That’s why it’s wise to seek out products certified by the United States Pharmacopeia (USP), which vets a supplement’s manufacturing process and the final product. A USP stamp on the bottle, Cohen says, vastly decreases the likelihood of too much or too little melatonin in a supplement. “But even if it has a USP stamp, that doesn’t mean it will be effective,” he says. (For more about third-party testing of supplements, see CR’s previous coverage.)

It’s also important to be aware of melatonin’s limitations. Judith A. Owens, MD, director of sleep medicine at Children’s Hospital Boston, says that while melatonin may help with falling asleep, it’s not meant to help someone stay asleep and it won’t improve sleep quality. 

Rather than relying on supplements to improve your or your child’s sleep, Owens recommends implementing a consistent sleep routine. “Doing the same things every night for the 20-minute period before you’re ready to go to bed can help you prepare mentally and physically for going to sleep,” she says. 

Common sleep hygiene practices—such as cutting out electronics, and limiting caffeine and alcoholic beverages—and practicing mindfulness before bedtime can all help facilitate a good night’s rest.

Plus, behavior change is more likely to yield lasting results, without the potential risks associated with supplements or drugs. “Just like sleep medications, melatonin is a Band-Aid,” Owens says, “unless you actually do the work needed to fix the underlying cause of the problem.”