“None of us really anticipated it being that large of a surge,” Vohra said.
In a report issued June 3 by the Centers for Disease Control and Prevention, the team cited the rising popularity and availability of melatonin, the increase in sleep disturbances caused by the pandemic, and the extra time children have been spending at home as possible contributors to the soaring number of reported ingestions.
The report, based on information reported to the American Association of Poison Control Centers’ National Poison Data System about patients 19 or younger, said that most children who had taken melatonin (82.8 percent) were asymptomatic, most were 5 or younger and most cases (94.3 percent) involved unintentional ingestions, defined by the system as “exposure resulting from an unforeseen or unplanned event.”
Most cases were managed at home, but 10.7 percent of patients were seen at a health-care facility. Among them, 14.7 percent were hospitalized and 1 percent (287 patients) required intensive care. Five children were put on ventilators and two children died.
While the ICU cases and deaths are concerning, “We at this time are not asserting that melatonin directly led to serious outcomes, including death,” Vohra said, because of the limitations of poison center data and the lack of individual case narrative reviews.
“We don’t want to set off alarm bells among parents, since the majority of melatonin ingestions are relatively benign and resolve without complications,” Vohra said. He added that the intent of the paper was to describe the increase in pediatric melatonin ingestions and to start a discussion. The research team and other experts have called for more study.
“It is unusual to see somebody become seriously ill after taking melatonin,” said Kevin Osterhoudt, a member of the American Academy of Pediatrics’ Council on Injury, Violence, Poison Prevention and the medical director of the Poison Control Center at the Children’s Hospital of Philadelphia.
“I think we need to look at the data more,” Osterhoudt said. “And we still have to define how big of a dose is dangerous, and if there are any people who might be at particular risk.”
“I think that this is the sort of data, where you’re actually getting into hospitalizations and fatalities, that I think underlines the importance of this issue,” said Craig Canapari, a pediatrician and director of the Yale Pediatric Sleep Center.
Melatonin is a naturally occurring hormone produced by the pineal gland that helps regulate the sleep-wake system. In the United States, it is considered a dietary supplement, and synthetic melatonin is available over the counter in a variety of doses and formulations, including pills, liquids, chewable tablets and gummies, which experts said might be particularly appealing to children.
While research has not definitively determined that taking melatonin can help with chronic insomnia — there is more data to support its use in treating jet lag and sleep issues caused by shift work — it is generally considered safe and non-habit-forming, which is part of its appeal. Nielsen estimates that sales of melatonin nearly tripled in the United States from 2018 to 2022, and research conducted before the pandemic found that usage was up among adults and children.
The CDC report noted that “the largest annual increase in pediatric melatonin ingestions coincided with the onset of the COVID-19 pandemic.” The researchers said this uptick could be connected to the documented pandemic-related rise in sleep problems, which probably led to more melatonin being available in households where kids were spending more time than usual, because of lockdown orders and remote schooling.
How to use melatonin for sleep
“Children developmentally are naturally curious,” Osterhoudt said. “The more that products are sold, and the more accessible they are in the home, the greater the likelihood that children will get into them.”
That melatonin is regulated as a dietary supplement in the United States rather than as a medication could be contributing to the problem in several ways, experts said. First, “That may lead some parents to store it in different ways in their house than they might if they thought it was a medication,” Osterhoudt said. Second, children may be able to get into melatonin more easily than other products because supplements often lack child-resistant safety caps. Third, the Food and Drug Administration does not regulate the manufacturing of supplements as rigorously as it does medications.
An oft-cited study in Canada, which, like many other countries, has since banned over-the-counter sales of melatonin, found that the melatonin content in OTC products can vary widely and does not always match what’s on the label.
Here are the lessons experts say parents should take from the CDC report.
Do not give melatonin to a child under age 3, and do not do so without consulting a medical provider. “I wouldn’t recommend that kids get melatonin really, unless [parents are] working closely [with] their pediatrician or more likely, honestly, a specialist,” Canapari said. He added that the supplement can have efficacy in children with attention-deficit/hyperactivity disorder or autism. Also, do not exceed the dosage recommended by your provider.
Store your melatonin safely. Melatonin should be “kept out of sight, out of reach and out of mind of young children,” Osterhoudt said. Vohra also said it’s important to keep medications in their original containers.
Be intentional about your purchase of melatonin. Buy melatonin products that bear the label USP Verified. “That means that that supplement manufacturer has gone through extra procedures to assure that their quality control is good,” Osterhoudt said. He also encourages parents to buy from companies that use child-resistant safety caps on their products.
Know the phone number of America’s Poison Control Centers. The number is the same across the country — 800-222-1222 — “and there will be a nurse, a pharmacist or a doctor on the other end of the line that will be happy to talk to any family through the situation,” Osterhoudt said.
Do not turn to medication first. Melatonin can have side effects and sometimes can make sleep issues worse, Canapari said. In many cases, what’s needed is a simple behavioral change, such as making sure a child has an age appropriate bedtime and a good nighttime routine. “These things are very powerful,” Canapari said. “They don’t cost anything, and they’re very safe as well.”
Take sleep issues seriously. “If your child has sleep problems, it is absolutely worthy of talking about it with your pediatrician,” Canapari said. Some signs are if your child frequently takes a long time to fall asleep, wakes up in the middle of the night or is difficult to rouse in the morning (excluding teenagers). “I think in general as parents we do well to listen to our little inner voice if we feel like something is a problem or just a persistent pain point, a source of conflict,” Canapari said. “It doesn’t hurt to pick up the phone. That’s why us kid doctors are there.”
Have a question about parenting? Ask The Post.