TGA reports safety concerns over imported melatonin products

The Therapeutic Goods Administration (TGA) has issued a safety advisory regarding imported unregistered melatonin products, following testing by TGA Laboratories.

The results indicate significant discrepancies in the actual melatonin content compared to the labelled amounts — for example, one product contained more than 400% of the labelled content and another containing no melatonin at all. This variability in melatonin content raises serious safety concerns for consumers, especially in children, according to the TGA.

The following products contained significantly more than the labelled amount:

Product	Variation from labelled amount
Spring Valley Melatonin 10 mg	119–136%
Natrol Melatonin 5 mg gummies	140–170%
CVS Health Melatonin 3 mg	112–121%
The Smurfs Kids Gummies Melatonin 1 mg	155–170%
Natrol Advanced Sleep Melatonin 10 mg	112–123%
Sleepose-3 Melatonin 3 mg	209–417%
Nutraceutical Sleepose-3 Melatonin 3 mg	95–174%
Vitafusion Sleep Well - Melatonin 3 mg	106–124%

The following products contained significantly less than the labelled amount:

Product	Variation from labelled amount
Life Extension Melatonin 300 mcg	79–97%
Sleepose-10 Melatonin 10 mg	37–59%
Live Natures Melatonin 10 mg	No melatonin detected

Worryingly, these discrepancies come as the TGA reports an increase in Australians purchasing melatonin products from online stores, particularly for use in children. These products are often sold as gummies but are also available as tablets or capsules marketed as dietary supplements.

The TGA advises extreme caution when considering purchasing any medicines, including melatonin, from overseas websites, as these products are not included in the Australian Register of Therapeutic Goods (ARTG) and so may not meet Australian standards for safety, quality and effectiveness. The products may even contain incorrect or undisclosed and harmful ingredients, putting consumers at serious risk of unpredictable or severe adverse reactions.

In Australia, most melatonin products are classified as prescription-only medicines, only available with a prescription from a qualified medical practitioner. Pharmacist-only melatonin products, which can be purchased following consultation with a pharmacist, include modified-release tablets containing 2 mg or less of melatonin for monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep for adults aged 55 or over, in packs containing not more than 30 tablets; and immediate-release preparations containing 5 mg or less of melatonin for the treatment of jet lag in adults 18 years and over, in a primary pack containing no more than 10 dosage units.

Melatonin is also approved as a prescription-only medicine for the treatment of insomnia in children and adolescents (2–18 years) with autism spectrum disorder (ASD) and/or Smith-Magenis syndrome. The TGA has not evaluated the safety or efficacy for broader use in children, and so advises that children suffering from sleep disorders or irregular sleep patterns should see a doctor and should not be given medicines purchased over the internet. Melatonin products taken without appropriate medical oversight can cause serious side effects including hospitalisation and accidental overdose, especially in children.

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