The NDPSC considered that insufficient information was available on the safety of melatonin to allow it to remain exempt from scheduling for human therapeutic use and that it should not be available without prescription.
It cannot be prescribed in Australia and is not available as a foodstuff, although people are able to bring personal supplies into the country. The popular culture of melatonin surrounds its sleep-promoting and suggested anti-ageing properties.
And despite the drug being banned in Australia, it is easy to find websites where you can buy Melanotan-II as a nasal spray or injectable vial, and have it delivered to your home.
In the UK and most of Europe, it's classed as a medicine, not a health supplement and as such, requires a prescription. This is because melatonin is considered “medical by function” which means that it requires a drug licence.
Melatonin Neurim can only be obtained with a prescription.
In Belgium and in Germany, products providing 0.3 mg or more of melatonin per day are considered medicinal products by function, in light of their pharmacological activity. In Spain and Italy, melatonin is authorised in food supplements up to 1 mg per day.
But it's legal to buy melatonin from overseas suppliers - and to bring them into the country without a prescription.
Recommended drugs available also in Italy are Triazolam and Temazepam (BDZ), Zolpidem and Zaleplon, (Z-drugs), Trazodone, and melatonin (as an over the counter preparation).
9. Where can I buy melatonin over the counter? The purchase of melatonin tablets is possible in Germany without a prescription in the form of food containing melatonin. However, in Germany, melatonin as a drug is only available on prescription at 2 mg and only for patients with a prescription from a pharmacy.
Dr Patels explains why this is: “We are regulated by the NHS, and the guidance from National Institute of Clinical Excellence (NICE) recommends the medication that doctors and GPs can prescribe, based on research and cost effectiveness. This is why [melatonin] is not as easily prescribed, or for prolonged periods."
Melatonin remains a prescription-only medicine for those under 55. In order to buy melatonin 2mg, you will require a prescription from an Australian registered doctor.
OTC melatonin has been banned for years in the United Kingdom (UK), European Union, Japan, Australia and most recently Canada. Exogenous melatonin is not outlawed by these countries but regarded as a medicine, available only by prescription.
Melatonin can now be sold over the counter in Australia, enabling insomniacs over 55 safer access to the sleep drug without a prescription. Australians insomniacs aged over 55 will no longer need to look overseas to source a sleep-inducing drug without a prescription.
Among banned substances are melatonin, which is taken to ease the effects of jetlag, and codeine, a common ingredient in pain relief medication. Possession may lead to a jail sentence of up to 15 years.
Regardless of whether it truly helps with sleep or not, Dr. Ramkissoon doesn't recommend taking melatonin long-term.
These are the most commonly used sleeping tablets in Australia and include temazepam (Temaze, Normison), zopiclone (Imovane) and zolpidem (Stilnox). They work by enhancing the activity of sleep pathways in the brain. They are recommended for short term use (less than 4 weeks). Melatonin (Circadin).
Melatonin medication in the form of sustained-release tablets are available only on prescription in Switzerland.
The agency says the fact that melatonin is legally available as a dietary supplement elsewhere in Europe, for example in Spain, Italy, and Poland, has led to a steady increase in imports of melatonin-containing products, which is reflected in the high levels of customs seizures.
A Marketing Authorization (MA) is required for selling melatonin in dosages above 0.3 mg. The Dutch Health Care Inspectorate (IGZ) warned repeatedly that it will enforce against the sale of such products, without having an MA.
Earlier this year the Italian Ministry of Health cut the maximum allowed level of melatonin in nutritional supplements from 5mg per day to 1mg per day - citing EFSA health claims approvals and the fact that 2mg doses are approved for medical uses as reasons for the move.
Melatonin is also sold at the Turkish pharmacies OTC, and over the internet in Turkey.
Antihistamine/Cetirizine (Benadryl/Zyrtec)
Used to treat allergies, runny nose and for relief from itching – the Italian equivalent is Zirtec (same, just with an 'i' instead of a 'y').
You can buy melatonin in Denmark if you have a prescription from your doctor. If your doctor finds that you should be treated with melatonin, we recommend that you buy the medicine from a pharmacy or an online pharmacy that we have authorised to sell medicines to consumers.
It's sold as a complementary medicine and comes as standard capsules, tablets or a liquid that you drink. However, these supplements are not authorised for sale in the UK and it's a prescription-only medicine. Ordering melatonin online is not recommended.
In the UK melatonin is a prescription medication. However, in many countries it is classed as a dietary supplement and can be bought in health food shops. Buying melatonin supplements from abroad, e.g. as melatonin 'gummies', is not recommended as they are not authorised for UK sale and therefore unregulated.