Melatonin Use Is Rising in U.S. Children, Study Finds

School-age children and preteens are taking the hormone melatonin before bed with increased frequency, despite the supplement lacking strict regulations by the Food and Drug Administration (FDA), recent research published in JAMA Pediatrics suggests. 

Melatonin is a hormone produced in the brain’s pineal gland that helps maintain our circadian rhythm—the 24-hour internal clock that regulates our sleep/wake cycles. Melatonin supplements have grown in popularity in the United States to help combat insomnia during recent years. 

In several other countries, such as the United Kingdom, melatonin is only available with a prescription. But in the U.S., the substance is classified as a dietary supplement, meaning it is regulated differently than “conventional” foods and drugs. The FDA does not approve supplements for safety, effectiveness or their labeling before they are sold. Instead, the supplement companies themselves are responsible for making sure their products are safe and accurately labeled, per the FDA. The administration has not yet approved any sleep-promoting medications for kids under 18. 

To estimate prevalence of melatonin use among children, scientists surveyed nearly 1,000 U.S. parents during the first half of 2023, per a statement from the University of Colorado Boulder. They found that among kids ages 5 to 9, 18.5 percent had been given melatonin in the previous 30 days. For those ages 10 to 13, that rose to 19.4 percent. And about 6 percent of preschoolers ages 1 to 4 had taken melatonin supplements in the past month. In 2017 to 2018, only about 1.3 percent of parents reported that their children used melatonin, per the statement. 

Cora Collette Breuner, a pediatrician at the University of Washington, tells NPR’s Maria Godoy that scientists don’t have much data on melatonin’s long-term effects on children. “I counsel patients and families about this on a daily basis—and my colleagues—that when we don’t know something in terms of what the long-term effect is, especially on a growing brain and growing body, then we shouldn’t use it without more data,” she says to NPR.

Previous research has found that melatonin gummies often contain different amounts of melatonin than what the label suggests. In April, scientists published a paper analyzing 25 different gummy products and found that 22 were mislabeled. One contained 347 percent the amount indicated on the label, while another contained no detectable melatonin at all. 

Per Boston Children’s Hospital, melatonin may benefit some kids who have trouble falling asleep, when it’s accompanied by behavioral interventions to address sleep problems, such as limiting electronics time before bed and keeping a mostly consistent bedtime. But some experts argue the supplement should be given as a last resort, and only after consulting with a child’s pediatrician. 

In a statement, the Council for Responsible Nutrition (CRN), a trade association representing the dietary supplement industry, says the recent study raises “unnecessary alarm about pediatric use of melatonin.” 

“What this study doesn’t show is how many families already administer melatonin to their children safely, in consult with, and in many cases, at the suggestion of, their health care providers,” Steve Mister, president and CEO of CRN, says in the statement. “Misrepresenting the state of regulation and mischaracterizing the data to pediatric doctors make those candid and fact-based conversations less likely.”

Both the authors and CRN point out that the 1,000 families included in the study make up a relatively small sample size—and they don’t necessarily represent nationwide use. Still, such a high frequency of melatonin use could point to underlying sleep issues in kids, lead author Lauren Hartstein, a sleep researcher at the University of Colorado Boulder, says in a statement. 

“We hope this paper raises awareness for parents and clinicians and sounds the alarm for the scientific community,” Hartstein says in the statement. “We are not saying that melatonin is necessarily harmful to children. But much more research needs to be done before we can state with confidence that it is safe for kids to be taking long-term.”

Margaret Osborne | | READ MORE

Margaret Osborne is a freelance journalist based in the southwestern U.S. Her work has appeared in the Sag Harbor Express and has aired on WSHU Public Radio.