A new study published in the Journal of the American Medical Association has found that melatonin gummies contain much higher percentages of melatonin than advertised on the label. Researchers at Cambridge Health Alliance and the University of Mississippi analyzed 25 supplements of melatonin, and discovered that taking the hormone in gummy form could mean children are ingesting unpredictable quantities of melatonin. They found that the quantity of melatonin in products ranged from 1.3 mg to 13.1 mg per serving size and the actual quantity of melatonin ranged from 74% to 347% of the labeled quantity. In fact, 88% of the products were inaccurately labeled, and only 12% contained a quantity of melatonin that was within ±10% of the labeled quantity.
The study’s findings are alarming, especially given the fact that pediatric melatonin ingestions have increased by 530% from 2012 to 2021, resulting in 27,795 emergency department and clinic visits, 4,097 hospitalizations, 287 intensive care unit admissions, and 2 deaths. Dr. Steven Feinsilver, director of the Center for Sleep Medicine at Lenox Hill Hospital, said, “These findings don’t surprise me… there is a history of this type of variable with melatonin products—often much less and much more than what is on the label, and that’s been disturbing.”
Dr. Feinsilver also emphasized that taking too much melatonin can be dangerous. He said, “Generally, it’s pretty benign, but occasionally has been bad and can be pretty sedating, especially at high doses.” Short-term effects of melatonin can include headaches, nausea, dizziness, agitation, elevated blood pressure, and vivid dreams or nightmares. It can also affect the effectiveness of other medications and supplements.
Melatonin is not regulated by the Food and Drug Administration (FDA) in the United States and Canada. It is regulated as a dietary supplement, not a pharmaceutical, which means there is little regulatory oversight, and supplements are not held to the same high standards of quality assurance or clinical data supporting safety or effectiveness before they are marketable. The lack of regulation also affects standardization for dosages, and people may have different responses to the same dose.
Dr. Raj Bhui, sleep specialist and spokesperson for the American Academy of Sleep Medicine (AASM), said, “Unfortunately, this means there is little regulatory oversight and supplements are not held to the same high standards of quality assurance or clinical data supporting safety or effectiveness before they are marketable…This is particularly important in the developmental context, as animal models raise concerns about long-term use potentially affecting puberty and reproductive hormones.”
Dr. Feinsilver recommends melatonin to adult patients for two conditions only—jet lag and REM sleep disorder. He typically recommends 5mg for REM sleep disorder because studies for this condition show that between 4mg and 12mg is safe and effective. However, he emphasizes that even then, people should try to find a reputable brand and stick to it because there may not be consistency within brands either.
The study’s findings raise important questions about the use of melatonin as a sleep aid for children. Dr. Bhui said that there is a general misperception that melatonin supplements are always safe because it naturally occurs in the body. “If you have heard the idiom ‘too much of a good thing,’ melatonin is no exception and inappropriate use can have unwanted effects,” he said.
Parents who want to give their children melatonin as a sleep aid should proceed with caution and consider other options. “Additional research supporting the effectiveness and safety of CBD in treating specific sleep disorders would be necessary before I could recommend it over proven treatment options,” said Dr. Bhui. While melatonin may seem like a convenient solution for children who have trouble sleeping, the risks associated with taking it outweigh the potential benefits.
The American Academy of Sleep Medicine (AASM) advises against the use of melatonin in healthy children and adolescents, except in certain circumstances. According to the AASM, melatonin should only be used in children with specific sleep disorders under the guidance of a physician.
Furthermore, the AASM recommends that parents prioritize good sleep hygiene practices over the use of melatonin. These practices include establishing a consistent bedtime routine, limiting screen time before bed, and ensuring that the child’s sleeping environment is conducive to sleep.
Despite the risks associated with melatonin use, many parents may still be tempted to try it as a sleep aid for their children. Dr. Bhui suggests that parents speak with their child’s pediatrician before giving them melatonin. The pediatrician can help determine if the child has a specific sleep disorder that may benefit from melatonin use and can advise on the appropriate dosage.
Additionally, parents should be aware of the potential side effects of melatonin use in children. These can include morning grogginess, headaches, dizziness, and even nightmares.