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Melatonin pills and gummies are soaring in popularity, but researchers worry about perceived harmlessness and a lack of regulation over the industry.(Image credit: rbkomar via Getty Images)Share this article 0Join the conversationFollow usAdd us as a preferred source on GoogleSubscribe to our newsletter
Visit any U.S. pharmacy, and you’ll encounter a diverse array of melatonin supplements marketed for both adults and children as sleep aids.
The hormone melatonin, produced naturally by the body, courses through our systems each evening, signaling readiness for rest. However, while melatonin supplements claim to replicate this natural function, experts suggest that bottles bearing statements such as “100% drug free” might be misleading.
While melatonin generally poses minimal risk when used appropriately, its classification as a dietary supplement means it bypasses the stringent governmental oversight applied to pharmaceuticals. This regulatory gap, some scientists contend, has resulted in inaccurate dosage declarations, incomplete safety advisories, and a scarcity of research on the long-term effects of melatonin, particularly in children. Researchers express concern that, due to a widespread perception of melatonin as innocuous, some individuals are misusing the supplement by consuming excessive amounts at inappropriate times of the day.
“It’s being promoted as if there’s absolutely no risk … [People say] ‘It’s all natural, and it just is a safe sleep aid,'” stated Dr. Pieter Cohen, a researcher at Harvard Medical School specializing in supplements. “And that’s where potential issues can arise.”
In the U.S., the Food and Drug Administration (FDA) categorizes melatonin as a supplement, whereas nations like the U.K. and Australia classify it as a medication. This distinction entails a degree of governmental supervision that is not applied to U.S. supplements. Given melatonin’s rapidly growing popularity, some specialists believe the United States should adopt a similar approach and reclassify melatonin as an over-the-counter drug.
But if melatonin is already a natural component produced by the body, why would the supplement version present any risks?
Supplements aren’t well regulated
In the U.S., a federal statute enacted in 1994 mandated that supplements be regulated as food products rather than drugs. The FDA does not evaluate the safety, effectiveness, or manufacturing quality of supplements prior to their market release; instead, it intervenes only if adverse effects are reported or if it becomes aware of mislabeled products. This framework largely places the responsibility for self-regulation on the supplement industry.
Cohen’s investigations indicate that the actual melatonin content in products can vary, ranging from 74% to 347% of the amount stated on the label. Furthermore, there is no requirement for safety warnings or usage instructions to be included on labels. Nevertheless, numerous widely used brands comply with voluntary labeling recommendations set forth by the Council for Responsible Nutrition, a trade association for the supplement sector. These guidelines include disclaimers such as “may cause drowsiness” and “for occasional or intermittent use only.”
Despite these caveats, close to 1 in 5 school-aged children reportedly use it on a regular basis for sleep difficulties, a trend that alarms scientists. Comprehensive long-term safety data for children is scarce, partly because melatonin has not undergone the rigorous safety testing required for new pharmaceuticals. Additionally, as melatonin is not patented, there is little financial incentive for pharmaceutical companies to invest in safety studies, according to Debra Skene, a neuroendocrinologist at the University of Surrey in England. “There’s no financial gain involved,” she remarked.
Many parents incorrectly perceive melatonin as being equivalent to a “little glass of warm milk,” Cohen observed. However, if children are given high-dose supplements or multiple doses concurrently, “you’re looking at adverse reactions, getting sick, and not improving sleep,” he cautioned.
Reports to U.S. poison control centers concerning melatonin poisoning in young children have surged in tandem with the supplement’s increasing popularity. This rise has been attributed to accidental ingestions by children under the age of 5, some of whom experienced severe symptoms, including respiratory failure or seizures. It should be noted, however, that some of these effects might stem from the inclusion of serotonin in certain melatonin products, which can be hazardous in substantial quantities.
There is indeed evidence suggesting that melatonin can assist children with attention-deficit/hyperactivity disorder and autism in falling asleep, as sleep disturbances are prevalent among these populations. However, the potential benefits of melatonin for neurotypical children remain less clear.
Extensive research on the long-term safety of melatonin use in children has been limited.
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One area of concern for scientists is the potential impact of regular melatonin use on puberty. In various animal species, melatonin plays a role in regulating reproduction, and exogenous melatonin can interfere with these processes. Although the few existing human studies have not shown definitive effects on puberty, in-depth studies tracking blood hormone levels have been lacking, according to Helen Burgess, who researches circadian rhythms at the University of Michigan.
“I am comfortable with intermittent, short-term usage,” she commented regarding melatonin supplementation in children. However, given the insufficient data, she advised parents to consult a pediatrician to explore alternative solutions if their child requires melatonin regularly.
The lesser-known effect of melatonin
Supplements significantly boost the body’s melatonin levels, noted Margarita Dubocovich, who studies melatonin at the University at Buffalo. Typical supplement dosages range from 1 to 10 milligrams (mg), whereas adults naturally produce approximately the equivalent of a 0.3-mg pill each night, she explained.
When ingested orally, supplements and medications undergo processing in the digestive system before entering systemic circulation. This means that the entire dose of melatonin may not necessarily reach the bloodstream. However, the concentration that does circulate will still be considerably higher than the naturally produced levels, according to Skene.
Increasing your melatonin dosage does not induce profound sedation; the sleepiness caused by the supplements is generally mild. The supplement also avoids the adverse effects associated with conventional sleeping pills, such as memory impairment, gastrointestinal distress, and next-day grogginess.
However, melatonin possesses a less commonly recognized effect. Due to its role in regulating the circadian rhythm — the approximately 24-hour internal clock that governs numerous bodily functions — it can disrupt the body’s sense of timing when taken consistently outside of its natural sleep cycle, such as too early before bedtime or during the night.
This is why melatonin can be effective in managing jet lag when taken for several days preceding or following travel. But if individuals consume the pills while experiencing nighttime wakefulness, it could potentially desynchronize the circadian rhythm, Dubocovich warned. This practice might induce a form of jet lag (without the accompanying international travel). In the short term, this can manifest as daytime drowsiness, irritability, stomach upset, cognitive fog, and insomnia.
Melatonin can impact the body’s circadian rhythm, potentially contributing to insomnia.
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“I believe melatonin could be beneficial if taken in a controlled manner and at the correct dosage,” Dubocovich stated, suggesting a few milligrams administered just before bedtime. “However, the way people are currently consuming it, they are essentially poisoning themselves.”
Not all researchers concur that melatonin-induced jet lag presents a significant risk, but consuming more than 3 mg in the middle of the night is still “not advisable,” according to Burgess. Such a dose might persist in the body into the morning, she noted, leading to next-day grogginess.
Burgess’s research indicates that supplemental melatonin is most effective at advancing the biological clock, a process that occurs when it is taken in the early evening. Nevertheless, she asserted that the impact of melatonin on the circadian rhythm “just does not seem to be genuinely acknowledged or understood by the public at all.”
Should melatonin be a drug?
If melatonin were classified as an over-the-counter medication, it would necessitate clear labeling with usage instructions and accurate dosage information. “You ought to be able to ascertain the dose you are receiving, and it should not be sold in whatever quantity the manufacturer … decides to include on any given day,” Cohen remarked.
However, reclassifying it could compromise access to a relatively safe sleep aid upon which many consumers depend, argued Jeff Ventura, a spokesperson for the Council for Responsible Nutrition, the trade organization for the supplement industry that established the melatonin labeling guidelines. “Moving melatonin into the drug category would necessitate formal FDA drug approval processes, which could restrict consumer access, diminish product variety, and substantially escalate costs” for both producers and consumers, he communicated to Live Science via email.
It is improbable that the supplement will be reclassified as an over-the-counter drug in the near future. Cohen attributes this lack of substantial movement to the lobbying efforts of the supplemental industry, which includes the Council for Responsible Nutrition. “Any attempt to remove such a significant revenue generator as melatonin from their control would provoke intense opposition,” he predicted.
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Burgess, who sits on the scientific advisory board for the melatonin brand Natrol, concurs that product purity is a valid concern. Nevertheless, she stated that she is not overly worried about melatonin’s accessibility, given its “fairly benign effects.” She does, however, advise opting for a well-known brand with a U.S. Pharmacopeia (USP) verification mark, confirming that its listed ingredients are accurate; USP is an independent organization that establishes quality standards for medications, food ingredients, and dietary supplements.
Having dedicated 40 years to studying the hormone, Dubocovich agrees that melatonin should be regulated as an over-the-counter medication.
“Melatonin can help promote restful sleep, particularly in small doses that align with the body’s natural rhythm,” Dubocovich concluded. “But it’s important to recognize that not all melatonin products are equivalent.”