May result in overdose of melatonin and CBD ingestion
Researchers are advising clinicians to warn parents that pediatric use of melatonin gummies may result in ingestion of unpredictable quantities of melatonin and cannabidiol (CBD).
A recent paper in JAMA analyzed the quantity of melatonin in gummies and found that some gummies contained not only much higher than labeled melatonin, but some also contained cannabidiol (CBD). Further research is needed, as this sample size was small and only looked at gummies, not tablets or pills.
Melatonin use in children increased during the pandemic. Calls for pediatric melatonin ingestions to US Poison Control Centers increased 530% from 2012 to 2021 and were associated with 27,795 emergency department and clinic visits, 4097 hospitalizations, 287 intensive care unit admissions, and 2 deaths.
The Food and Drug Administration has not approved the use of CBD in children except to treat refractory seizures caused by 3 rare genetic disorders.
The great majority of melatonin gummy products were inaccurately labeled, with most products exceeding the declared amount of melatonin and CBD. To the researchers’ knowledge, this is the first US study to quantify melatonin in over-the-counter melatonin products. A Canadian study had similar results: analysis of 16 Canadian melatonin brands found that the actual dose of melatonin ranged from 17% to 478% of the declared quantity.
Melatonin products are not approved by the US Food and Drug Administration (FDA). Instead, they are sold over the counter as dietary supplements or food, and some products include prohibited drugs such as cannabidiol (CBD). Given that children might intentionally or unintentionally ingest melatonin gummies, researchers assessed the actual quantity of melatonin and CBD in these products compared with the quantities declared on the labels.
Prior to the COVID-19 pandemic, melatonin was used by an estimated 1.3% of children in the US, most commonly for sleep, stress, and relaxation. Despite the lack of high-quality evidence to support melatonin’s efficacy for these indications in healthy children, use increased during the COVID-19 pandemic.
Administration of as little as 0.1 mg to 0.3 mg of melatonin to young adults can increase plasma concentrations into the normal nighttime range. Consuming melatonin gummies as directed could expose children to between 40 and 130 times higher quantities of melatonin. Unintentional ingestions could lead to consumption that greatly exceeds these dosages of melatonin. With respect to CBD, the drug is FDA approved to treat refractory seizures caused by 3 rare genetic disorders, but the FDA has not approved the use of CBD for any indication in healthy children.
This study has limitations, including that the sample size was small, only 1 sample of each brand was analyzed, and only gummies were analyzed. It is not known if the results are generalizable to melatonin products sold as tablets and capsules in the US or if the quantity of melatonin within an individual brand may also vary from batch to batch.
CDC Warns parents about melatonin.
FDA looks at CBD in products.