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In the news again: The safety of melatonin gummies

We previously reported on the multiple concerns about melatonin gummy supplements including the published data on the spike in calls to the US Poison Control Centers regarding children’s ingestion and misuse of melatonin that resulted in the need for some form of medical care.


However, this topic is making news again after the publication of the research letter on April 25, 2023, from the Journal of American Medicine (JAMA). This letter details the inaccurate levels of melatonin found in various gummy products that were primarily marketed to improve sleep in adults. 


JAMA reported that 22 of the 25 melatonin gummy supplements tested were inaccurately labeled based on the actual, tested amount of melatonin found in the products. The variation was a 74-347% increase of the label dose compared to the actual dose. Additionally, 5 of the products claimed to contain CBD as an ingredient, and this too was found to have ranges above the label amounts of 104-118% more CBD.


What should we do with this information?


First, with the growing concern about the use of melatonin supplement safety in children, it can serve as a good reminder for parents and clinicians to use caution when considering melatonin supplements in children. The evidence suggests that melatonin supplements are not the first line therapy for sleep concerns in children, further supporting this should only be considered in children with health conditions including ADHD and Autism.


Second, the supplements tested were marked to adults, not children. However, gummy supplements are very popular in the pediatric population for the ease associated with taking them. Careful examination of the label would be recommended.


Third, several of the melatonin supplements made claims to support sleep or relaxation. Interestingly, most of them contained doses of melatonin (5-10 mg) that are higher than what research suggests for daily sleep support. Others contained 3 mg of melatonin which is ideal for occasional sleep disturbances, such as jet lag or shift work, rather than daily sleep support. The physiological dose for adults of 0.3 mg – 1.0 mg is supported by the literature for daily sleep support and realignment of the circadian rhythm.  While higher pharmacological doses (>3 mg) can be supportive for other health concerns.


In choosing melatonin supplements, it is best to work with a qualified healthcare provider who can recommend a high-quality supplement given in the proper dose, supported by evidence, for any given health concern.

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