A recent study conducted by researchers at the University of Colorado Boulder has raised significant concerns about the increasing use of melatonin among children in the United States.
The study reveals a startling trend: nearly one in five school-aged children and preteens are taking melatonin for sleep. This practice has also extended to preschoolers, with some parents giving melatonin to children as young as one year old.
Dr. Lauren Hartstein is a postdoctoral fellow in the Sleep and Development Lab at CU Boulder and the lead author of the research. She studies how environmental cues, including light at night, impact children’s sleep quality and melatonin production.
“We hope this paper raises awareness for parents and clinicians, and sounds the alarm for the scientific community,” said Dr. Hartstein.
“We are not saying that melatonin is necessarily harmful to children. But much more research needs to be done before we can state with confidence that it is safe for kids to be taking long-term.”
Melatonin, a hormone produced in the pineal gland, plays a crucial role in signaling the body’s readiness for sleep and regulating the circadian rhythm.
While it is classified as a drug requiring a prescription in many countries, melatonin is readily available over the counter as a dietary supplement in the United States. Its easy accessibility, including child-friendly gummies, has contributed to its widespread use.
“All of a sudden, in 2022, we started noticing a lot of parents telling us that their healthy child was regularly taking melatonin,” said Dr. Hartstein.
The researchers are particularly concerned about the slim safety data for melatonin products and the lack of full regulation by the Food and Drug Administration (FDA).
The study involved a survey of about 1,000 parents in the first half of 2023. The data showed that 18.5% of children aged 5 to 9 and 19.4% of preteens aged 10 to 13 had been given melatonin in the previous 30 days.
Notably, about 6% of preschoolers aged 1 to 4 had also used melatonin in the prior month. This is a significant increase from the 1.3% usage rate reported during 2017.
The dosage of melatonin varied with age, with preschoolers taking between 0.25 to 2 mg and preteens taking up to 10 mg. The duration of use also raised concerns, with preschoolers taking melatonin for a median length of a year, and older children using it for even longer periods.
Further complicating the issue, a study published in April found inconsistencies in the melatonin content of various gummy products, with some containing different amounts than indicated on the label. One product had more than three times the amount on the label, while another product had none at all.
This discrepancy, along with the presence of other substances like serotonin in some supplements, highlights the risks associated with these unregulated products.
“Parents may not actually know what they are giving to their children when administering these supplements,” said Dr. Hartstein.
The potential impact of melatonin on the developing brains and bodies of young people, including the timing of puberty onset, is a topic that requires more research.
The study authors also point out the risk of children mistaking melatonin gummies for candy, leading to increased reports of accidental ingestion and calls to poison control centers.
The researchers noted that from 2012 to 2021, reports of melatonin ingestion to poison control centers increased 530%, largely occurring among children under age 5. More than 94% were unintentional and 85% were asymptomatic.
Study co-author Dr. Julie Boergers is a psychologist and pediatric sleep specialist at Rhode Island Hospital and the Alpert Medical School of Brown University.
Dr. Boergers said that melatonin can be a useful short-term aid, particularly in youth with autism or severe sleep problems, when used under the supervision of a health care provider.
“But it is almost never a first-line treatment,” she said, noting that she often recommends that families look to behavioral changes first and use melatonin only temporarily. “Although it’s typically well-tolerated, whenever we’re using any kind of medication or supplement in a young, developing body we want to exercise caution.”
Another unintended consequence of introducing melatonin to kids is it could send the message – if you have trouble sleeping, a pill is the answer, said Dr. Hartstein
“If this many kids are taking melatonin, that suggests there are a lot of underlying sleep issues out there that need to be addressed,” Dr. Hartstein noted. “Addressing the symptom doesn’t necessarily address the cause.”
The experts caution that their study was relatively small, which means it does not necessarily represent usage nationwide.
The study is published in the journal JAMA Pediatrics.
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