Melatonin gummies: Australia’s drug regulator issues safety warning over popular sleep “supplements”

From BMJ, 7 October 2025:

Australia’s drug regulator has issued a safety warning about imported unregistered melatonin gummies, many of which contain far more of the hormone than labelled.1

Testing by the Australian drug regulator, the Therapeutic Goods Administration (TGA), identified eight unregistered brands of melatonin gummies that were advertised as containing 1-10 mg of melatonin but had anywhere from 112% to 417% of the stated dose.

Another three brands contained less melatonin than advertised, including one with no detectable amount.1 “This variability in melatonin content raises serious safety concerns for consumers, including the risk of hospitalisation and accidental overdose, especially in children,” the TGA said. Read more.