Melatonin is a natural hormone produced by the (deep-brain) pineal gland that regulates sleep and wakefulness cycles. Production by the body is strongly linked to light levels received through the eyes; light inhibits production and as such the modern world of artificial lighting and audio-visual devices is strongly inhibitory towards a healthy and natural melatonin cycle.
In Australia melatonin is classified as a Prescription Only medication, available only following a consultation with a doctor. This restriction on melatonin in Australia is partially a quirk of history; 1989 saw an outbreak of illness in the US caused by a contaminated batch of a related medication, L-tryptophan, that hospitalised 1000 and caused 30 deaths. As a result the US FDA immediately banned all forms of tryptophan supplements and Australia’s TGA followed suit shortly after. Melatonin was introduced as an alternative for the US market shortly after, however it was not registered in Australia and as such has remained a prescription only medication since then. (Until Feb 2021, when it will become OTC).
Being a generally safe, effective, and well tolerated medication it is understandable that demand for melatonin without a medical consultation and prescription is growing. Some patients have used a homeopathic version of the medication available over the counter at pharmacies, however all research to date has found that homeopathic medications are not efficacious for any medical condition and as such we do not stock or recommend them.
As the medication is available over-the-counter in other countries some customers have begun to purchase and import from International suppliers. This too can be problematic as importation of a Prescription Only product contravenes the Poisons and Therapeutic Goods Act and can be punishable by fines of up to $200,000 per instance. The safety of these imported goods also cannot be guaranteed due to the often poorly enforced safety and quality standards that exist in a number of origin countries. Only medications and suppliers that have been audited and registered with the Australian TGA are guaranteed for safety and quality. The 1989 experience in the US is a salient reminder of the importance of rigorous safety measures in medications, and we are committed to ensuring that all our products and suppliers conform to the standards expected in Australia.
We highly recommend that you seek medical advice before commencing melatonin treatment. A prescription is required for any supply of melatonin in Australia.
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