Other safety alerts
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| Australia: Clinicians and pharmacists – Are your patients aware of the risks of buying melatonin online? |
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The Therapeutic Goods Administration (TGA) announces that melatonin is a hormone that is naturally produced in the brain to help control our body’s sleep/wake cycles. Like all medicines, products containing melatonin can cause adverse effects that clinicians and pharmacists should let their patients know about. These risks are significantly heightened if patients use unapproved melatonin purchased from overseas or online sources or compounded, where quality, potency, and safety cannot be assured.
In September 2025, TGA issued a public safety alert after its laboratory testing revealed significant dose inconsistencies in unapproved melatonin products bought from overseas websites. Some products contained up to 400% more melatonin, while others contained less than stated or none. These variations pose serious risks, including overdose, hospitalisation, and adverse reactions, particularly in children.
Melatonin products presented as gummies or lolly-like formulations pose a significant risk of accidental overdose in children due to their appealing appearance and ease of consumption. Symptoms of melatonin toxicity in children can include:
- Extreme sleepiness
- Vomiting
- Slurred speech
International reports have linked melatonin overdose to several child fatalities in the United States, underscoring the seriousness of this issue.
There is a growing number of Australians who are buying melatonin online because of the perceived cost benefits, perceived ease of availability and driven by associated misinformation that downplays the risks. Clinicians and pharmacists play a key role in identifying and managing the risks associated with unapproved melatonin products. Clinicians may prescribe prescription‑only melatonin to patients under their care when clinically appropriate, ensuring the dose, formulation, and duration are consistent with approved indications and directions for use.
Melatonin, in specified formulations and doses, is also available as a pharmacist only medicine in Australia for the short term treatment of insomnia in adults aged 55 years and older, and for jet lag in adults aged 18 years and older. Clinicians and pharmacist can help by advising patients not to purchase melatonin from unverified online sources. Patients should be advised to only purchase melatonin from an Australian-based pharmacy.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/blog/clinicians-and-pharmacists-are-your-patients-aware-risks-buying-melatonin-online
In Hong Kong, there is no registered pharmaceutical product containing melatonin. Related news was previously issued by TGA, and was posted on the Drug Office website on 27 Sep 2025 and 30 Jan 2026.
Ends/Wednesday, Feb 11, 2026
Issued at HKT 15:00
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