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What pharmacists need to know as pediatric melatonin overdoses surge
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What pharmacists need to know as pediatric melatonin overdoses surge

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Sonya Collins

Photo of sleeping teenagers.

The number of annual calls to poison control for pediatric melatonin overdoses increased by a whopping 530% from 2012 to 2021. These were the findings of a cross-sectional study of pediatric melatonin ingestions reported to U.S. poison control centers published in CDC’s Mortality and Morbidity Weekly Report (MMWR) in June 2022.

Researchers and health care providers tend to attribute the surge in part to both the uptick in sleep troubles children experienced during the COVID-19 pandemic, and the supplement often coming in a gummy form that’s easily mistaken for candy.

Not all the symptoms of pediatric melatonin overdose are benign. Two deaths associated with the supplements were reported in the MMWR data. Pharmacists should take every opportunity to educate parents on the safe use of melatonin in children.

OTC supplements aren’t always what they say they are

While most reports of melatonin overdoses in children involve mild symptoms, such as drowsiness, nausea, and vomiting, 287 children recorded in the MMWR study were admitted to ICUs for ingestions; five required ventilators; and two died.

As melatonin in high doses is not known to cause such serious effects, these outcomes serve as a reminder that the ingredients in OTC supplements are not always exactly as they are listed on their labels.

According to Cydney McQueen, PharmD, clinical associate professor at University of Missouri-Kansas City School of Pharmacy, pharmacists should advise patients, parents, and caregivers that when buying supplements for children, they should buy only brands that carry the seal indicating that the manufacturer participates in USP’s Dietary Supplement Verification Program.

“That is an indicator that the manufacturing facilities are being inspected and the products are regularly tested to make sure they contain what the label states,” said McQueen, who has expertise in natural medicines and dietary supplements.

Recent research confirms that the labels on melatonin products cannot always be trusted. A JAMA study from April 2023 that analyzed 25 brands of gummies found significant variation in contents across products, and major discrepancies between the amount of active ingredient listed on the label and that contained in the gummy.

One product contained no detectable melatonin but rather 31.3 mg of CBD. The quantity of melatonin in the other gummies ranged from 74% to 347% of the labeled quantity. Eighty-eight percent of the products were inaccurately labeled, and only 12% of the products contained a quantity of melatonin that fell within 10% of the amount on the label. Among those products that listed CBD on the label, the actual amount ranged from 104% to 118% of the declared amount.

A study of Canadian melatonin products yielded similar results. Across 16 brands, the melatonin dose ranged from 17% to 478% of that listed on the label.

Use the smallest effective dose

Since melatonin products can contain so much more of the active ingredient than their labels declare, parents and caregivers should start children on the smallest possible dose.

“Only very low doses are needed to give a big boost to the amount of melatonin that our bodies are already producing,” said McQueen. “For children especially, a dose of 0.3 to 1 mg is appropriate. Those doses can also be appropriate and effective for most adults, although up to 5 mg could be used.”

Manage expectations

Parents and caregivers should not expect melatonin to take effect right away, nor should they increase the dose to get faster results.

“I usually describe it as ‘helping to make the attempts to sleep more successful.’ ” McQueen said. “Effects are seen over the course of several days or weeks as the sleep patterns improve. Even though some individuals may sense some improvement within a night or two, most won’t—and we shouldn’t think of using melatonin for immediate relief of insomnia.”

Melatonin is not for every child

Because melatonin is a hormone produced by the pineal gland in the brain, parents should administer it judiciously. It is generally considered safe for use in younger children and in older post-pubescent teenagers, but not in peripubescent adolescents.

“Melatonin should not be used in adolescents, as it is used by the body to trigger some changes associated with puberty,” McQueen said.

Finally, parents should be made aware of interactions that melatonin can have with other drugs, including seizure medications, immunosuppressants, and the antidepressant fluvoxamine. ■



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