TGA cautions consumers about online melatonin products
29 Sep 2025
The Therapeutic Goods Administration (TGA) has issued its first safety alert about unregistered melatonin products imported into Australia, warning that they can pose serious health risks to consumers.
The TGA advises anyone using unregistered melatonin products to stop immediately and return any remaining supply to a pharmacy for safe disposal. Consumers, particularly parents, are urged to speak with a GP to obtain prescription-only melatonin if needed.
Tests conducted by the TGA found significant discrepancies in online melatonin products. Of the products tested:
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Eight contained much more melatonin than the label stated.
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Two contained much less than advertised.
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One contained no melatonin at all.
The TGA said these variations could lead to serious side effects, including accidental overdose, particularly in children. Products sold online without a prescription are considered extremely risky.
Melatonin use has grown worldwide in recent years. For example, in the United States, use of melatonin supplements among adults increased five-fold between 1999 and 2018. Some popular products tested by the TGA showed large differences from the labelled dose. For example:
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Health Melatonin 3 mg varied 112–121% from the labelled amount.
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Sleepose-3 Melatonin 3 mg varied 209–417%.
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Live Natures Melatonin 10 mg contained no detectable melatonin.
The TGA continues to warn consumers to exercise extreme caution when buying medicines from online stores, social media, or other digital platforms. A recent rise in melatonin overdoses has prompted this targeted safety alert. In response, the US online retailer iHerb has stopped selling melatonin to Australian customers.
Dr Tim Jones, RACGP Specific Interests Child and Young Person’s Health Chair, said the alert aligns with concerns about unregulated melatonin products for children, particularly gummy supplements, which may contain widely varying doses. He emphasised that sleep issues should first be addressed with strategies rather than medication where possible.
The TGA also encourages GPs to report any adverse health events associated with melatonin use, highlighting the role of health professionals in managing risks linked to unregistered products.
Source: Therapeutic Goods Administration (TGA)
