A new study by F.D.A. scientists found that some products contained more than six times the amount on the label.
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.