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Gummies, chocolate and even jelly beans: Melatonin supplements marketed for children are popular among parents struggling to get kids to sleep, and are often recommended by doctors for this purpose.
But the amount of melatonin in these products can vary enormously, with some products containing none at all and others containing a potentially hazardous amount, according to a new analysis of 110 products marketed as melatonin for children. The study, led by a team of researchers that included Food and Drug Administration scientists, found that only half of the products tested contained the amount of melatonin that was claimed on the package. Some contained up to 50 milligrams — many times more than the 0.5 to 1 milligram starting dose that some pediatric sleep experts recommend.
Experts say the findings raise urgent questions about the safety and quality of the melatonin products that more parents are turning to as sleep aids for their children.
“How can clinicians and parents make informed decisions about safety and efficacy when we have no idea what dose of melatonin children are actually receiving?” said Julie Boergers, co-director of the pediatric sleep disorders clinic at Brown University Health.
Melatonin products, which deliver either a natural or synthetic version of a hormone produced by the body at night to help regulate sleep, have been used as sleep aids by adults in the United States for decades. But researchers have seen a sharp uptick in use among children in the last few years. Early in the Covid-19 pandemic, a survey conducted by YouGov for The New York Times found that nearly half of children with trouble sleeping had taken it. Another survey, conducted in 2023 by Dr. Boergers and her colleagues, found that about 18 percent of children ages 5 to 9, and about six percent of children ages 1 to 4, had been given melatonin in the previous month.
Manufacturers have responded to the demand by making products specifically for use by children, including chocolates and jelly beans. The products sometimes claim to have lower doses than adult supplements typically contain. The supplements analyzed in the study included products sold at big-box retailers and pharmacy chains, and on Amazon.
But because they are considered dietary supplements, they are not subject to the same safety and efficacy standards, or the same level of testing, as pharmaceuticals sold in the United States, said Pieter Cohen, an associate professor at Harvard Medical School who studies supplements including melatonin. Dr. Cohen has conducted research showing that melatonin gummies often do not claim the amount contained on the label.
“A company can put out what they want and no one’s following up on testing or efficacy,” said Dr. Binal Kancherla, a pediatric sleep medicine specialist at the Texas Children’s Hospital in Houston. “It’s all anecdotal.”
For some parents who use the supplements, there’s no question that melatonin can help their children feel sleepy. But whether it’s effective in helping them fall asleep sooner and stay asleep for longer is less well understood. Many studies on the sleep benefits of melatonin for children have relied upon a small number of subjects, and some studies have failed to show any benefit. There is some evidence that melatonin can help treat sleep problems for certain children, including adolescents entering puberty, for whom a natural delay in melatonin secretion leads to delayed sleep, and some children with autism spectrum disorders.
Dr. Kancherla said that she often prescribed melatonin to children to help with sleep issues, as the best of a limited set of treatment options for children. No sleeping medication has been approved for use in children, but doctors sometimes prescribe other drugs off label to help them sleep.
She called the results of the new study “alarming, but not surprising.”
The F.D.A. said the results of the study “will be taken into consideration,” but declined to discuss how it would further evaluate the safety of melatonin supplements.
Experts said it wasn’t clear what health risks too much melatonin might pose to children, or what constitutes too high of a dose. An overdose can cause excessive drowsiness, stomach pain and dizziness.
In recent years, more children have unintentionally ingested melatonin, sometimes accessing bottles without child-safe packaging. This has led to a rise in calls to poison centers and visits to emergency rooms across the United States, according to the Centers for Disease Control and Prevention. Few of the approximately 11,000 emergency room visits for accidental melatonin ingestion between 2019 and 2022 resulted in children being hospitalized. The C.D.C. has said that more research was needed to understand the potential harms to children.
Dr. Boergers advised that families use only pharmaceutical-grade melatonin, over-the-counter supplements that have been third-party tested by an independent nonprofit, so that they could be confident in the amount listed on the label.
Dr. Cohen said that when used appropriately, and in very small dosages, melatonin was considered safe. It’s unfortunate, he said, “that the lack of quality control of the products leads to situations where kids are exposed to dosages that are greatly exceeding what’s considered reasonable.”
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