According to a new lab analysis published in the April 25 copy of JAMA, ‘nearly 90 precent of melatonin gummy brands don’t contain the amount of melatonin indicated on the label.’
In an alarming instance, the gummies actually had more than 3 times the listed amount of melatonin. Such discrepancies could inadvertently expose children to doses significantly surpassing recommended levels, even when the supplements are consumed as directed, as noted by the authors of the study.
Too Much Melatonin Can Dangerous For Kids
Melatonin is a hormone that is naturally produced by the body during the night. It aids in synchronizing biological and behavioral rhythms with the light-dark cycle. According to the National Center for Complementary and Integrative Health, it can be effective in regulating sleep patterns by either advancing or delaying the body’s internal clock.
However, the study authors point out that the prevalence of mislabeled melatonin gummies is a cause for concern, especially in light of their appeal to children due to their gummy form.
When it comes to children, it’s incredibly important to pay attention to the dosage.
Lead author Pieter Cohen, MD, an internist at Cambridge Health Alliance and an associate professor of medicine at Harvard Medical School in Boston, said, “We became concerned about melatonin supplements after toxicologists published an analysis last year of calls to the U.S. Poison Control Centers of pediatric melatonin ingestions.”
The researchers of the study also found that between the years 2012 and 2021, there were more than a quarter-million calls to emergency about melatonin ingestions in children, which is a whopping 530 percent increase over the last decade, explains Dr. Cohen.
“The consequences for the children could be very serious: 27,795 required medical evaluation, 4,097 hospitalized, and two deaths. But it’s not known why melatonin supplements were causing these harms, so we set out to understand what was actually in melatonin gummies, commonly used by both children and their parents — and the results are quite shocking,” he says.
3 Times More Melatonin Levels Found in Some Supplements, Exceeding Label Claims
After looking at and analyzing as many as 25 different melatonin brands purchased online, these were the key findings that researchers found:
- Out of the 25 products evaluated, 22 were inaccurately labeled, deviating by more than 10 percent from the indicated melatonin content.
- Melatonin content ranged from 74 percent to 347 percent of the amount specified on the labels, with most products containing 20, 30 or even 50 percent more than what was declared.
- Four products contained less melatonin than labeled, with one even lacking detectable levels of the hormone.
- Additionally, five products included cannabidiol (CBD) as an ingredient, all of which had slightly higher CBD levels than indicated on the labels.
The researchers emphasized that a mere 0.1 to 0.3 milligrams (mg) of melatonin could elevate blood plasma concentrations to within the normal nighttime range in young adults. However, for children consuming gummies even as directed, their exposure could potentially be between 40 to 130 times higher than the recommended dosage.
While the measured doses generally deviated only slightly from the labeled amounts, this discrepancy can be attributed to the nature of melatonin’s effect. Rather than inducing sedation, melatonin facilities the onset of sleep by mitigating the arousal prompted by the circadian rhythm in the evening, says Dr. David Neubauer, a sleep expert from John Hopkins Medicine in Baltimore, who was not involved in the study.
“Fortunately, these small differences between the measured amounts and label doses are not likely to have any clinical significance,” says Dr. Neubauer.
He goes on to explain that it’s because ‘melatonin is not fundamentally a sedating compound. Instead, it facilitates bedtime sleep onset by reducing the arousal promoted by the circadian rhythm in the evening.’
“Smaller and larger doses tend to have about the same effect, so the dose is not critical for this dietary supplement as it is with most prescription medications. There is rarely a reason to take a large dose, though melatonin products can be bought with 10 mg, 15 mg, 20 mg, 25 mg, and even 60 mg as their labeled doses,” adds Dr. Neubauer.
Possibly 1 in 4 Healthy Kids Have Sleeping Issues
According to a JAMA paper, while melatonin supplements are generally well-tolerated and safe, there are some potential risks associated with adverse effects, like headaches, dizziness, fatigue, and daytime sleepiness.
Particularly concerning are the melatonin supplements that come in gummy form, since they can be easily mistaken by children as candy, which is why the importance of storing them out of the reach of children is very important, explains Dr. Neubauer.
Professor of pediatrics at the University of British Columbia and emergency pediatrician at BC Children’s Hospital in Vancouver, Canada, Ran Goldman, MD, said that ‘it’s estimated that 1 in 4 healthy children and adolescents and as many as 3 in 4 children with neurodevelopmental or psychiatric conditions experience sleep issues.
Dr. Goldman, who was not part of this study, has published research on ‘sleep-related used of melatonin in healthy children.’
Is Melatonin Safe for Children?
“Sleep hygiene is key to resolving causes of insomnia. I recommend that parents and children first ensure they follow those steps, which include regular bedtime and bedtime routine, avoiding screens and meals before sleep, [having a] dark and quiet room, and sleeping in a child’s own bed,” says Dr. Goldman.
He says that if parents want to give their kids melatonin to help them sleep, his suggestion is to talk to the family’s primary medical provider or pediatrician first. He explains, “If melatonin is given in a correct way and in a safe dose, it may help many children with insomnia fall asleep or stay asleep. Most healthy children do not need more than 0.5 mg or 1 mg taken 30 to 90 minutes before bedtime,” he says.
Melatonin is an active hormone, so we need to treat it like any medication, says Cohen. “If you’re going to use it, it’s very important to use the correct dose. Given what we found in this study — and what prior studies have shown about the poor quality of dietary supplements — it’s important that consumers choose products that have been certified by either USP (United States Pharmacopeia) or NSF to ensure that the labels are accurate,” he says.
Symptoms of Melatonin Overdose in Children
According to the Cleveland Clinic, these are the most common symptoms of melatonin overdose in children:
- Upset stomach
- Vomiting
- Diarrhea
- Tiredness
While serious overdoses are considered rare, and symptoms tend to resolve on their own, if you are worried about your child, always call your local poison control center to be sure.
Recommended For You
