A revealing analysis of common over-the-counter sleeping pills reveals that they contain wildly varying amounts of melatonin, with some containing up to 347% of the amount listed on the label.
The study, published Tuesday in JAMA, found that 22 of the 25 melatonin gummy products analyzed, or 88%, were inaccurately labeled. That is, they contained more than 10% more or less melatonin than what was indicated on the packaging. Together, the dietary supplements contained a range of melatonin from 1.3 mg to 13.1 mg per serving. And those actual amounts were a range of 74% to 347% of what they were supposed to contain based on their labeling.
The finding highlights a greater concern about the quality, safety and effectiveness of dietary supplements, which are not controlled or approved by the Food and Drug Administration, like over-the-counter drugs, such as ibuprofen and allergy medications. The multi-billion dollar industry has long ignored significant concerns about quality control, safety, lack of efficacy data, and hyped health claims.
Although the consequences of a melatonin overdose are unlikely to be extremely dangerous or fatal, the finding is concerning because melatonin can have unpleasant side effects and it is commonly used in children. The gummy versions of the supplement, the subject of this study, are particularly likely to be given to children.
Melatonin is a hormone produced by the brain in response to darkness and supplement makers have marketed it as a potential sleep aid and relaxant. Although some studies indicate that melatonin supplements are better than a placebo for helping children sleep, the data is sparse and there is a lot of uncertainty about its use. Unknowns include the ideal dose and timing, as well as long-term effects and whether it might alter hormonal development in children and young adults.
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Side effects and adverse events are also not well documented. But in children, experts say the risks of melatonin include excessive sleepiness and increased bedwetting, as well as many factors that can disrupt sleep, such as headaches, nausea, nightmares, dizziness and mood swings.
“The administration of as little as 0.1 mg to 0.3 mg of melatonin to young adults may increase plasma concentrations into the normal nighttime range,” wrote the authors of the JAMA study, led by Pieter Cohen. , a supplement safety expert at the Cambridge Health Alliance. However, the amounts in the gums were 40 to 130 times higher than these amounts.
Cohen and colleagues note that about 1.3% of American children were taking melatonin before the pandemic, and that number likely increased amid the stressful health emergency. Between 2012 and 2021, calls to poison control centers for children taking melatonin increased by 530%, according to data published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report. These calls were associated with 27,795 emergency room and clinic visits, 4,097 hospitalizations, 287 intensive care unit admissions and two deaths.
The new JAMA study has limitations; it only looked at gummy products and did not perform lot-to-lot analysis. But a 2017 study by Canadian researchers of 31 melatonin supplements in chewable tablets, capsules, and liquids found similar variability in the products. The melatonin content varied from 83% to 478% of what was written on the labels, and the content from batch to batch varied up to 465%. Additionally, 26% of the products also contained undisclosed amounts of serotonin, a neurotransmitter that can be harmful even in low amounts.
Last year, the American Academy of Sleep Medicine issued a health advisory on the use of melatonin, especially in children. Parents are advised to speak with pediatricians before using the hormone, which the American Academy of Pediatrics also recommends.