Some recent media coverage may lead consumers to believe that Australian complementary medicine sleep products contain melatonin. This is incorrect.
Setting the record straight
No listed complementary medicines in Australia contain melatonin. Under Australia’s world-class therapeutic goods regulatory framework, melatonin is only available as a prescription-only medicine (Schedule 4) for most consumers, and as a pharmacist-only medicine (Schedule 3) for adults over 55 with specific conditions or people experiencing jetlag.
Sleep support products available over-the-counter in Australian pharmacies, supermarkets and health stores are formulated with low-risk ingredients that have been approved by the Therapeutics Goods Administration. This does not include melatonin.
Protecting Australian consumers
Media misinformation creates unnecessary alarm among consumers who rely on high quality, regulated complementary medicines. Australian consumers can have confidence in products which have an AUST L, AUST LA or AUST R number on the labels.
These products are manufactured in TGA-licensed facilities under pharmaceutical-grade Good Manufacturing Practice standards, ensuring the highest quality and safety standards globally.
All complementary medicines sold legally in Australia must be entered on the Australian Register of Therapeutic Goods (ARTG) before they can be marketed. This regulatory oversight ensures products meet strict safety and quality requirements, with clearly defined ingredients and dosages.
Don’t buy products from overseas
Buying health products online carries significant risks, including exposure to counterfeit, contaminated, or substandard goods that have not been assessed for safety, quality, or efficacy under Australia’s stringent therapeutic goods framework.
Unregulated overseas supplements may contain undeclared ingredients, variable dosages, allergens, or prescription-only substances, increasing the chance of adverse reactions and dangerous interactions with medicines.
Complementary medicines sold legally in Australia must display an AUST L, AUST LA, or AUST R number on the label. This confirms the product is included on the Australian Register of Therapeutic Goods (ARTG) and is subject to strict, mandatory safety and quality standards.
Vitamin and mineral products without these numbers are illegal and should be avoided. This provides immediate visibility of whether a product is subject to mandatory Australian standards.
Consumer safety
To ensure safe use of complementary medicines, CMA encourages consumers to:
1. Only choose products with AUST L, AUST L(A), or AUST R numbers on the label
2. Follow dosage instructions carefully
3. Discuss supplementation with healthcare professionals, especially when taking medications
4. Be aware of vitamin and mineral intake levels if consuming multiple products
For consumers seeking reliable information about complementary medicines, we recommend consulting the TGA website, speaking with qualified healthcare professionals, particularly those with extensive training in nutrition, and choosing products that meet Australian regulatory standards. By focusing on quality, safety, and professional guidance, Australians can continue to benefit from complementary medicines while minimising any risks.
Disclaimer
Copyright © 2025 Complementary Medicines Australia Limited (CMA) ABN 49 169 036 088. This publication is general information only. It is not intended to constitute any form of health, legal or professional advice, and no representations or warranties as to its accuracy, currency or completeness are made. Seek independent professional advice before making any decisions concerning your interests. To the extent permitted by law, CMA excludes all liability relating to this publication. This publication has been developed and/or compiled solely for the benefit of members of CMA and their employees. It is not permitted to share any part of this publication by any means with non-members without the express permission of CMA. People who are not members of CMA are prohibited from reading, using and/or accessing this publication or any part of it. CMA members who share or permit their employees to share all or part of this publication by any means with non-members may face disciplinary consequences including but not limited to suspension or cancellation of their membership. In addition, CMA reserves its rights to take such action (including legal action) as it considers appropriate in such circumstances.
