According to a new study by researchers at Colorado University Boulder, nearly one in five children took melatonin within a month, which is exponentially greater than just a few years ago. The findings were published in JAMA Pediatrics.
 
During the year spanning 2017-2018, only about 1.3% of parents reported that their children used melatonin, but, according to a survey of 1,000 parents in the first half of 2023, melatonin use soared to 18.5% in kids between five and nine, 19.4% for preteens between 10 and 13, and 6% in preschoolers between the ages of one and four.
 
Preschoolers had been melatonin users for a median length of one year, while grade-schoolers and preteens had used it for median lengths of 18 and 21 months, respectively,.
 
There was a positive association between age and size of the nightly dosage, with preschoolers taking dosages between 0.25 and 2 milligrams and preteens taking up to 10 milligrams.
 
The authors of the study told CU Boulder Today that their results should be drumming up concern, since safety and efficacy data for melatonin products doesn’t meet drug standards as determined by the U.S. Food and Drug Administration. Because of that, and evidence that melatonin supplements are highly variable in dosage and quality, it’s not possible to conclude that children are taking safe amounts.
 
Co-author Julie Boergers, PhD, told the university newspaper that healthcare practitioners typically exercise caution when administering melatonin to children, using it in the short term and never as a first line of treatment.
 
CRN: Study is Rife with “Alarming Misinformation”
 
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), said that the rates of melatonin usage among children were neither pejorative or surprising. He also questioned JAMA Pediatrics’ review process after pointing out what he considered flaws and inaccuracies in the authors’ data and claims.
 
As a preface to their findings, the authors cited two studies about melatonin.
 
The first study, published in JAMA, found that ingredient overages were widespread in melatonin products, available on the markets. Mister noted at the time that the U.S. Food and Drug Administration (FDA) allows reasonable overages in dietary supplements per regulation to ensure efficacious dosages throughout the shelf life, and the overages presented in this study didn’t reach dangerous levels.
 
The other study, published last year, pointed out that the number of poison control center calls involving parents asking about children taking melatonin experienced a sharp uptick. But the authors didn’t take any medical data or comorbidities into account into their reporting, therefore, a call to poison control to inquire about accidental ingestion doesn’t implicate that any adverse event occurred. Further, there was no evidence external to the study that adverse events in children related to melatonin use, which are exceedingly rare, are on the rise.
 
The authors also perpetuate a false narrative that dietary supplements “are not regulated by the FDA,” CRN reported.
 
“This research letter should be received as a call to pediatric doctors to have candid and open conversations with parents about their children’s sleep patterns, and about the use of melatonin, which these findings, and our own data, show is used safely by millions of American families,” Mister said. “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 healthcare providers. Misrepresenting the state of regulation and mischaracterizing the data to pediatric doctors make those candid and fact-based conversations less likely.”