Melatonin may not be as safe as you think, pediatrician says

Concerns include extra ingredients and kids getting adult doses of popular sleep aid

Melatonin may not be as safe as you think, pediatrician says

If your child is having trouble sleeping, the quick fix of melatonin may not be a permanent, or good, solution.

Melatonin is a popular over-the-counter sleep aid and supplement. It’s also a hormone your brain produces naturally through the pineal gland.

According to a 2022 Sleep Foundation study, 27.4% of U.S. adults take melatonin. A 2023 study, also from the Sleep Foundation, found nearly half of parents give their kids melatonin for sleep.

Overdose is possible

Stephanie Hanson, M.D., is a pediatrician at Sanford Health in Fargo, North Dakota.

According to Dr. Hanson, even though melatonin is a substance our body naturally produces, she’s seen overdoses in children.

“In about a 10-year span, from 2012 to 2021, there were 260,000 cases of child poisoning involving melatonin (in the United States). Most of the time kids do fine and they don’t have any long-term problems, but there were some kids who needed to be admitted into the hospital. Two kids died as a result of melatonin poisoning,” she said.

“We just don’t know the long-term effect of melatonin use. Again, there’s nothing jumping out at us immediately as like, ‘this is immediately dangerous for you,’ but it’ll be interesting to see. It’s so widely used,” she added.

Overdose symptoms include extreme lethargy, unresponsiveness, and trouble breathing.

“I would say that some of the more common things people report to me when their kids are taking melatonin is difficulty waking up in the morning, nightmares or disrupted sleep, you know, later on in the night, or bedwetting,” she said. “Those are some things that can kind of come as a result of melatonin use.”

Oversight of nutritional supplements

The U.S. Food and Drug Administration has regulated all supplements, like melatonin, since 1994. Supplements fall under the food category, according to FDA guidelines.

Dr. Cara Welch, director of the FDA’s Office of Dietary Supplement Programs in the Center for Food Safety and Applied Nutrition, explained their regulatory role in an FDA podcast:

  • The FDA does not approve dietary supplements or their labeling. It also does not test dietary supplements before they are sold to consumers.
  • The FDA inspects dietary supplement manufacturing facilities, reviews new ingredient notifications, investigates complaints, examines dietary supplement imports, and reviews adverse event reports.
  • Companies that manufacture the supplements are responsible for meeting safety standards. Dietary supplement companies also are required to list nutrition information on a Supplement Facts label.

“FDA does test some dietary supplements but we’re talking about a marketplace of over 100,000 products and we have limited resources to analyze the composition of dietary supplements,” Dr. Welch said.

Melatonin is also present in some melatonergic drugs (Ramelteon, Agomelatine and TIK-301, for example), which are often used to treat insomnia or other sleep disorders or disturbances. Because of this, there are some instances where melatonin may also be regulated as a drug by the FDA because it is an ingredient of a melatonergic drug.

What you see isn’t always what you get

Dr. Hanson echoed Dr. Welch’s sentiments about supplements, stating that without “the strict monitoring we would see with other medications like ibuprofen or a cold medicine,” there’s no way to know exactly how much melatonin you are, or aren’t, getting.

“It might be labeled as three milligrams, but there could be six milligrams in there, or one milligram in there. What you see is not necessarily what you get,” she explained.

Dr. Hanson also said some other substances, like diphenhydramine (Benadryl) or CBD, could also be present in melatonin products.

A research study published in the Journal of the American Medical Association suggests the same:

  • 88% of melatonin products were inaccurately labeled (22 out of 25).
  • Actual amounts of melatonin ranged from 74% to 347% of the labeled quantity.
  • Three products out of 25 contained the advertised amount of melatonin.
  • One product did not contain any melatonin but instead contained 31 mg of CBD.

“Those substances are things you might not necessarily want to administer to your kids,” Dr. Hanson said.

She joins other providers in advising patients to be careful consumers.

Amy Dwight, APRN, CNP, a family medicine provider at Sanford Health, encourages patients to look for a United States Pharmacopeia label on any vitamin or supplement they buy. The USP label means an independent company reviewed it for quality and accuracy.

Don’t interrupt what your body already does

Remember, your brain already produces melatonin naturally. When melatonin is produced, it’s signaling bedtime.

Sometimes this signal can get disrupted because we ourselves disrupt it, according to Dr. Hanson.

“Too much screen time can impair your body’s production of melatonin. Lack of exposure to sunlight can also do it, same with erratic or irregular bedtime schedules,” she said.

Dr. Hanson recommends “getting back to basics” when it comes to improving your child’s sleep.

Getting back to basics includes:

  • Limiting screen time for at least an hour before bed
  • Creating a consistent bedtime routine
  • Having a dark, quiet sleep space
  • Eating well and getting enough exercise

She said she understands why parents would look into melatonin as a sleep aid for their children.

“We’re all tired, we’re all chronically overworked, schedules are tight. It takes a lot of parenting effort to get your kids on a regular routine, so I don’t blame people who are looking for anything out there to give them a little assistance in that area,” Dr. Hanson said.

Work with your primary care provider

If your child is having trouble sleeping, Dr. Hanson said the best place to start is with your primary care provider.

“They’re going to understand what your child’s specific health situation is and be able to refer you on,” she said. “Maybe they need a behavioral health provider on board, or maybe a sleep medicine doctor would be a better tool and be able to do a sleep study. We can do sleep studies at Sanford on kids of any age.”

Parents and caregivers should always consult their child’s primary care provider before giving their child melatonin in order to determine what dosage, if any, is appropriate.

Talk with your child’s provider to see if there are any other issues that might be causing your child’s sleep difficulties.

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Posted In Aberdeen, Children's, Fargo, Healthy Living, Nutrition, Sleep Medicine