Almost half (46%) of parents with children under the age of 13 have given their children melatonin to help them sleep at night, according to a survey commissioned by The American Academy of Sleep Medicine (AASM). Of those surveyed, millennial parents (50%) are most likely to have given melatonin to a child under the age of 13, compared to all other generations, and almost one-third (30%) of all parents reported having given their teenage children melatonin.
Dr M. Adeel Rishi, MD, chair of the AASM Public Safety Committee, said parents should consult with a health care professional before giving the supplement to their child to ensure proper dosage and timing.
“Many sleep difficulties children experience can be fixed with behavioral changes,” Rishi said. “Parents should help their child establish consistent bedtime routines and practice good sleep hygiene first, before turning to melatonin.”
Not all gummies are created equal
Melatonin, a natural hormone that helps regulate circadian rhythms and the sleep cycle, is the second-most popular supplement product that parents give to their children, next to multivitamins, according to the AASM. Melatonin use has increased in the last two decades across all ages and has led to more overdoses, calls to poison control centers, and emergency room visits for children, even more so during the Covid-19 pandemic, the organization added. Many of those cases had to do with unintentional ingestion.
Speaking previously to NutraIngredients-USA, Rick Kingston, PharmD, president of Regulatory and Scientific Affairs at SafetyCall International, said that when it comes to Poison Control calls, the totality of the experience – including the medical outcomes – must be considered.
“When you look at the actual outcomes associated with exposure calls to poison control centers, the safety of melatonin becomes more evident. As an example, in the most recently published Poison Control data from 2021, there were 54,669 single ingredient exposures reported and 44,868 were in children 5 years of age and under. Although these numbers sound daunting, the medical outcomes for all reported melatonin exposures including those involving adults reveal that the vast majority of outcomes were minor in nature (9,449) or reported no adverse effects at all (up to 82.7%). If you combine the minor effects with the no effect outcomes, they account for 99.7% of all exposures,” said Kingston. “When looking at melatonin, the exposure numbers are in favor of demonstrating safety, not unreason risk or injury.”
According to the Centers for Disease Control and Prevention the annual number of pediatric ingestions of melatonin increased 530% between 2012-2021. Additionally, melatonin content in supplements can vary.
Indeed, last April a letter published in JAMA indicated melatonin gummy products are often inaccurately labeled. Of the 25 gummy brands tested, 22 were inaccurately labeled–with variations in melatonin spanning from 74% to 347% of the amount advertised on the label.
Dr Michael Breus, PhD, founder of the Sleep Doctor, a sleep wellness company committed to improving sleep through education and products, said he would never recommend melatonin for children. It should be used in adults over age 18 who have jet lag, shift work, ADHD, REM Behavior Disorder, or who have a melatonin deficiency, he said.
“I would only consider a supplement if there was a deficiency. In 99% of these cases the kids are not even tested, much less have an identified deficiency,” Breus said. “Most children make 3 - 4x the amount of melatonin they need, so why add more?”
In most countries melatonin is by prescription only because it is a hormone, and at higher doses it is used as a contraceptive, he added.
Commenting on the survey, the Council for Responsible Nutrition (CRN) advises parents to consult their health care providers prior to giving their children melatonin or other dietary supplements and to keep all supplement products out of reach.
“Parents know how to take care of their own kids,” Steve Mister, president and CEO of CRN told NutraIngredients-USA. “In consultation with their health care providers, [they] have been safely giving the pediatric versions of melatonin products to their children for years.”
According to the National Center for Complementary and Integrative Health at the National Institutes of Health (NIH), “melatonin supplements at normal doses appear to be safe for most children” for short-term use.
However, a study published in 2021 by The Journal of Pediatric Pharmacology and Therapeutics said: “Evidence supporting the use of US formulations of melatonin in the otherwise healthy pediatric population is non-existent. Based on the lack of safety regulations in place in the United States and the lack of evidence regarding US melatonin products, they should be used sparingly in the otherwise healthy pediatric population, if they are used at all.”