Regulation of melatonin products in Australia

There has been 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.

Consumers who import these unregistered ‘melatonin’ products from online stores for personal use or use by an immediate family member risk serious health problems.

In Australia, melatonin is only approved for use in children as a prescription-only medicine in limited circumstances.

Specifically, melatonin is approved 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.

The TGA advises that children suffering from any medical condition, including sleep disorders or irregular sleep patterns, should see a doctor and not be given medicines purchased over the internet.

Approved melatonin products in Australia

Pharmacist-only medicines

Some melatonin products are classified as pharmacist-only medicines which can only be purchased following consultation with a pharmacist.

Pharmacist-only melatonin products registered in the Australian Register of Therapeutic Goods (ARTG) are approved for the following uses in adults only:

• 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, or
• 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.

Prescription-only medicines

All other melatonin products are classified as prescription-only medicines. These products are only available with a prescription from a qualified medical practitioner.

Risks of melatonin supplements purchased online

The TGA advises consumers to exercise extreme caution when considering purchasing medicines from overseas websites. These products are not included in the ARTG. Importantly, this means they may not meet Australian standards for safety, quality and effectiveness. These products may contain incorrect or undisclosed and harmful ingredients.

Recent testing by TGA Laboratories has shown many of these melatonin products contain significantly higher doses than the amount on their label, while others contained less or even no melatonin.

Unregistered products, especially those sold by online sellers that do not request a doctor's prescription, are extremely risky. Consumers can be put at serious risk of unpredictable or severe adverse reactions.

Parents are strongly encouraged to consult their child’s treating medical practitioner regarding the use of melatonin. Melatonin products taken without appropriate medical oversight can cause serious side effects including hospitalisation and accidental overdose, especially in children.

Reporting adverse events

Everyone can play an important role in monitoring the safety of therapeutic goods in Australia by reporting suspected adverse events to the TGA. While an individual report may not be enough to determine whether a particular therapeutic good caused an adverse event, all reports help to build a picture of the safety profile of a product and assist with the TGA's safety monitoring program.