Visit any American pharmacy, and you’ll find a multicolored range of melatonin supplements marketed as sleep aids for both adults and children.
The body-made hormone melatonin flows through our system each evening, preparing us for rest. But while melatonin supplements claim to mimic this natural process, experts say bottles with claims like “100% drug free” may be misleading.
Melatonin poses little risk when used correctly, but as a dietary supplement, it avoids the strong government regulation that is reserved for pharmaceuticals. Some scientists argue that this is due to inaccurate dosage labeling, incomplete safety information, and little research on the long-term effects of melatonin on children. Researchers are concerned that, given that many people consider melatonin harmless, some people are abusing the supplement by taking unnecessarily high doses at inappropriate times of the day.
“It is being promoted as if there is no risk… [People say] ”It’s all natural, and it’s just a safe sleep aid,” said Dr. Peter CohenA Harvard Medical School researcher who studies supplements. “And that’s where you can get into trouble.”
The US Food and Drug Administration (FDA) classifies melatonin as a supplement, while countries such as the UK and Australia consider it a drug. This designation comes with a level of government oversight that US supplements are not subject to. given The growing popularity of melatoninSome experts believe the United States should follow suit and make melatonin an over-the-counter drug.
But if melatonin is already produced naturally by the body, why would a supplemental version be risky? Live Science spoke to experts to find out.
Supplements are not well regulated
In America, a 1994 federal law What is required is that supplements be regulated as food, not drugs. The FDA does not assess the safety, efficacy, or manufacturing quality of supplements before marketing, but instead intervenes when harmful side effects are reported or when made aware of mislabeling. This largely leaves the supplement industry to self-regulate.
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Cohen’s research suggests The actual melatonin concentration in products can range from 74% to 347% of the amount stated on the label. Meanwhile, safety warnings and instructions on the best way to use melatonin on labels are not necessary. still, many popular brands follow volunteerism melatonin labeling guidelines From Council for Responsible NutritionA complementary trade organization. These guidelines include disclaimers such as “may cause drowsiness” and “for occasional or intermittent use only.”
Despite such disclaimers, About 1 in 5 school-going children Use it regularly as a sleep aid, a trend that has scientists concerned. Long-term safety data in children are lackingPartly because melatonin has not gone through the safety trials required for new drugs. And melatonin is not patented, so there is no strong incentive for drug companies to invest in safety studies, according to Debra SkeneA neuroendocrinologist at the University of Surrey in England. “There’s no money in it,” she said.
Many parents mistakenly equate melatonin with a “small glass of warm milk,” Cohen said. But if parents give children high-dose supplements or multiple doses at once, “you’re talking about side effects and getting sick and not helping with sleep,” he said.
calls to US Poison Control Center about melatonin toxicity The popularity of supplements has increased among young children. It has been caused by accidental ingestion in children under 5 years of age, and in some cases, the children had serious symptoms such as respiratory failure or seizures. That said, some of those effects may be due to the inclusion of serotonin in some melatonin products, which can be dangerous If consumed in large quantities.
evidence suggests Melatonin may help sleep in children with attention-deficit/hyperactivity disorder and autism, including sleep problems are common. But its potential benefits melatonin for neurotypical children are less clear.
Little research has been done on the safety of long-term melatonin use in children.
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One concern among scientists is that regular use of melatonin may affect puberty. In various animal species, melatonin helps regulate reproductionand supplemental melatonin can cause disruption this effect. The few human studies that exist Not there. showed There are clear effects on puberty, but there have been no in-depth studies tracking hormone levels in the blood, it said. Helen BurgessWho researches circadian rhythms at the University of Michigan.
“I agree with intermittent short-term use,” he said of melatonin supplementation in children. But given the lack of data, they recommended that parents consult a pediatrician looking for another solution if they need melatonin on a regular basis.
Lesser Known Effects of Melatonin
The supplements supercharge the body’s melatonin supply, said Margarita DubokovichWho studies melatonin at the University at Buffalo. Supplement doses typically range from 1 to 10 milligrams (mg), while adults produce equivalent to a 0.3-milligram tablet At night, he said.
When taken orally, supplements and medications pass through the digestive tract before reaching the systemic circulation, meaning that a full dose of melatonin will not necessarily make it into the bloodstream. However, the amount that circulates will still be far greater than the amount naturally produced in the body, Skene said.
Increasing your melatonin dose doesn’t bother you; Drowsiness caused by supplements is generally mild. Supplement also avoids this Side effects of traditional sleeping pills: Memory loss, gastrointestinal problems and “hangover” the next day.
However, the effects of melatonin are less known. Given its role in regulating circadian rhythm – The 24-hour clock that controls many bodily systems – This can mess with the body’s sense of time when it is routinely taken outside of your sleep time, such as before bed or in the middle of the night.
That’s why melatonin can help cure jet lag If taken for several days just before or after travel. But if people take the pills while tossing and turning throughout the night, it could disrupt circadian rhythms, Dubokovitch said. This practice can induce a kind of jet lag (without the benefits of international travel). In the short term, it may come with drowsiness during the day, irritability, upset stomach. brain fog And insomnia.
Melatonin may affect the body’s circadian rhythm, which may contribute to insomnia.
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“I think melatonin can be good if you take it in a controlled manner and in the right dosage,” says Dubokovich, who suggests taking a few milligrams at bedtime. “But how people are taking it [currently]They are intoxicating themselves.”
Not all researchers agree that melatonin-induced jet lag poses a major risk, but taking more than 3 milligrams at midnight is still “not a good idea,” Burgess said. This dose may remain in the body until the morning, he said, causing drowsiness the next day.
Burgess’s research shows that supplemental melatonin is most effective at moving the biological clock forward in time, which is when it is taken in the evening. Still, he added that melatonin’s effects on circadian rhythms are “not really recognized or understood by the public.”
Should melatonin be a drug?
If melatonin were an over-the-counter drug, it would require clear labels with instructions and exact dosages. “You should be able to know what dose you are getting, and it should not be sold in any dosage by the manufacturer … who decides to put it out on a certain day,” Cohen said.
Nevertheless, arguments were made that reclassification could impede access to relatively safe sleep aids that many consumers rely on. Jeff VenturaSpokesperson for the Council for Responsible Nutrition, the supplement industry trade organization that created the melatonin labeling guidelines. “Moving melatonin into the drug category would require formal FDA drug approval pathways, which could limit consumer access, reduce product diversity, and significantly increase costs,” he told Live Science in an email.
It’s unlikely that the supplement will be made an over-the-counter drug any time soon. Cohen attributes the lack of a serious movement to the supplement industry lobby, including the Council for Responsible Nutrition. “Any move to take away a great money winner like melatonin will force them to fight tooth and nail for it,” he said.
Burgess, who serves on the scientific advisory board of melatonin brand Natrol, agrees that purity is an issue. However, she said she is not too concerned about the availability of melatonin, given its “fairly benign effects”. Still, she suggests going with a big-name brand. US Pharmacopoeia (USP) Stamp Verifying that its listed ingredients are accurate; USP is a nongovernmental organization that sets quality standards for drugs, foods, and dietary supplements.
After studying the hormone for 40 years, Dubkovic agrees that melatonin should be regulated as an over-the-counter drug.
“Melatonin may help with a good night’s sleep, especially in small doses that reflect the body’s natural rhythms,” Dubkovic said. “But not all melatonin is created equal.”
This article is for informational purposes only and is not intended to provide medical advice.
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