The melatonin content of sleep-aid gummies may be wrong by as much as 350%, according to a research.

According to the findings of the study that were presented in JAMA on Tuesday, 88 percent, or 22 of the 25 melatonin gummy products that were investigated, had incorrect labels. That is, they had more or less melatonin by more than 10 percent compared to the amount that was stated on the packaging. Melatonin doses per serving in the various dietary supplement items ranged from 1.3 mg all the way up to 13.1 mg when taken collectively. And the actual numbers represented anywhere from 74% to 347.5% of what they were meant to contain according to the labelling of the product.
This discovery brings to light a more widespread worry regarding the quality, safety, and efficacy of dietary supplements. Unlike over-the-counter drugs such as ibuprofen and allergy treatments, dietary supplements are not evaluated or approved by the Food and Drug Administration (FDA). The multi-billion dollar industry has, for a long time, brushed off significant concerns over quality control and safety, as well as a lack of data regarding effectiveness and exaggerated health claims.

It is highly improbable that an overdose of melatonin would produce immediate or life-threatening complications; yet, the discovery raises some cause for concern due to the fact that melatonin is known to have unpleasant side effects and is frequently prescribed to young patients. The chewable forms of the dietary supplement, which are the subject of the current research, are more likely to be administered to young children.

Melatonin is a hormone that is produced by the brain in reaction to the presence of darkness. Melatonin has been marketed by supplement manufacturers as a possible sleep aid as well as a relaxant. The data are limited, and there is a great deal of uncertainty regarding the use of melatonin supplements. Despite the fact that some studies suggest that melatonin supplements are more effective than a placebo at helping children sleep, this is not universally accepted. Unknowns include the optimal amount, when it should be administered, as well as long-term effects and the possibility that it could change the development of hormones in children and young adults.
Rude awakening
In addition, there is a lack of documentation regarding adverse occurrences and side effects. In children, however, the hazards of melatonin include excessive drowsiness and an increased risk of bedwetting, in addition to a wide variety of side effects that have the potential to interrupt sleep, such as headaches, nausea, nightmares, dizziness, and changes in mood.

“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,” the authors of the study that was published in JAMA said. The study was led by Pieter Cohen, a supplement safety specialist at Cambridge Health Alliance. However, the concentrations found in the gummy candies were forty to one hundred and thirty times higher than those amounts.

Cohen and colleagues observe that an estimated 1.3 percent of children in the United States took melatonin before to the pandemic, and it is likely that this percentage increased in the midst of the stressful health catastrophe. According to data that was presented in the Morbidity and Mortality Weekly Report by the Centres for Disease Control and Prevention (CDC), the number of calls to poison control centres that included youngsters using melatonin increased by 530 percent between the years 2012 and 2021. These calls were linked to 27,795 visits to emergency departments and clinics, 4,097 hospitalisations, 287 admissions to intensive care units, and two fatalities.

The new research published in JAMA has some shortcomings, such as the fact that it did not compare different batches of the gummy goods it examined. In contrast, researchers from Canada conducted a study in 2017 on 31 different melatonin supplements available in chewable tablet, capsule, and liquid form. They discovered a similarly wide range of quality across the items. The actual melatonin amount of the product ranged from 83 percent to 478 percent of what was printed on the labels, while the actual content ranged from batch to batch by as much as 465 percent. In addition to that, twenty-six percent of the goods also had undeclared quantities of the neurotransmitter serotonin, which, even in trace amounts, is capable of causing health problems.

In specifically for youngsters, the American Academy of Sleep Medicine published a health advice regarding the use of melatonin last year. Before utilising the hormone, parents are encouraged to consult with paediatricians, which is a recommendation that is shared by the American Academy of Paediatrics.