Melatonin industry asked to voluntarily tighten standards after dramatic rise in childhood ER visits
Melatonin industry asked to voluntarily tighten standards after dramatic rise in childhood ER visits
Melatonin manufacturers asked to voluntarily improve safety standards by industry trade group after reports of 530% rise in accidental ingestions by children.
Makers of melatonin supplements have 18 to 24 months to voluntarily add child-deterrent packaging and improve cautionary language on labels of over-the-counter products, according to the Council for Responsible Nutrition, the leading trade association for the dietary supplement and functional food industry.
Melatonin is a hormone produced by the brain in response to darkness. It regulates the body’s natural sleep-wake cycle or circadian rhythm. As a dietary supplement, melatonin is not regulated by the US Food and Drug Administration, yet the demand for melatonin among both adults and children has skyrocketed over the last decade, according to experts.
The council’s action follows recent reports of a massive rise in accidental ingestions of melatonin by children and an April 2023 study that found 25 products labeled as melatonin gummies contained dangerous levels of the hormone. One over-the-counter product contained up to 347% more melatonin than listed on the label, while another contained no melatonin at all — it was entirely composed of cannabidiol or CBD.
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"Administration of daily doses of up to 300 mg of melatonin without causing clinically significant adverse reactions have been reported in the literature.
If overdose occurs, drowsiness is to be expected. Clearance of the active substance is expected within 12 hours after ingestion. No special treatment is required."
https://www.ema.europa.eu/en/documents/product-information/circadin-epar-product-information_en.pdf
Maybe parents should be educated about the fact that it isn't dangerous in overdose? To stop pointless ER visits?
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The 300 mg dosing was adults, and they specifically said above it hadn't been tested in persons under 18. Little kids metabolize things differently. And most of the overdoses are gummies, so we're talking about coming in and potentially finding your greedy little goober has eaten your entire jar of 60 CVS gummies at 10 mg apiece. Trying to get them to puke while they're so sleepy could cause aspiration, and they're going to need monitoring to be sure they don't stop breathing, so it's off to the ER. And with the observation of widespread inaccurate dosing/labeling, the amount and type of drug ingested can only be guessed at.
Requiring a child guard cap and warning that effects in children have not been studied doesn't seem unreasonable. And quality control tests to ensure you're getting what you expect.
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As my wife the pediatrician often repeats when it comes to medicine: "children are not just little adults."
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Or you call your country's poision control hotline.
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I knew this fact specifically because my doctor researched it in front of me when I asked about taking melatonin. I was angrily scouring the article for some mention of what's dangerous here.
As best I can tell, there's no real effective overdose of melatonin. If you get too much, you end up not using it.
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