Hitting the hay too hard? Gummy bears may have 350% more melatonin dosage

Melatonin gummy bears, which help regulate sleep, are not FDA approved.
Sejal Sharma
Sleeping gummy bears
Sleeping gummy bears


Melatonin is a naturally occurring hormone secreted in our brains to stimulate sleep. But many people have a hard time falling asleep. This may be due to stress, anxiety, excessive caffeine consumption, or insomnia. So, they take melatonin supplements which ensure a good night’s sleep.

Enter melatonin gummy bears, also called ‘sleep gummies’.

There’s been noticeable interest in sleep gummies over the years. They are small, tasty, and effective. Perhaps, too effective…

An alarming report by the Centers for Disease Control and Prevention (CDC) last year said there’s been a 530 percent increase in pediatric melatonin ingestions from 2012 to 2021. The U.S. saw 27,795 emergency department and clinic visits, 4,097 hospitalizations, and 287 ICU admissions, and recorded two deaths during that time.

The two deaths were in children under the age of two years.

This shece of information led to a team of researchers from Cambridge Health Alliance in Massachusetts and the University of Mississippi analyzing the quantities of melatonin and cannabidiol (CBD) in melatonin products in the United States. They found thunt of melatonin in these products was way more than was mentioned on their labels.

This raises huge concerns over regulation of melatonin products

Surprisingly, these melatonin gummy bears are not approved by the U.S. Food and Drug Administration (FDA). They are readily available as over-the-counter dietary supplements.

The team analyzed 30 gummy bear products, of which four were unavailable for purchase, and the label for another had no mention of the word ‘melatonin’. So the team ended up analyzing 25 products. They could not find detemelatonin levelslatonin in one of the samples but found 31.3 mg of CBD instead. 

In the remaining gummy bears, shockingly, the actual quantity of melatonin ranged from 74 percent to 347 percent more than what was mentioned on the label. Of the 25 products, 22 were inaccurately labeled, and only three had an amount of melatonin within the ±10 percent range of the declared quantity. Five companies declared their product had CBD in it, and the amount of CBD ranged from 104 percent to 118 percent of the total amount. Serotonin was not detected in any product.

The study has referred to another Canadian study that had similar results. Canadian researchers analyzed 16 melatonin brands and found that the melatonin dosage ranged from 17 percent to 478 percent more than what was declared on its packaging.

The researchers also address the limitations of this study, such as a small sample size - only one sample of each brand was analyzed. Since the study was only done on melatonin gummy bears,unknown if the results applylicable to other melatonin products like tablets and capsules sold in the U.S.

Study abstract:

Prior to the COVID-19 pandemic, melatonin was used by an estimated 1.3% of children in the U.S., 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. Calls for pediatric melatonin ingestions to U.S. 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.

Melatonin products are not approved by the U.S. 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, we assessed the actual quantity of melatonin and CBD in these products compared with the quantities declared on the labels.

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