The applicant's reasons for the request are: Melatonin can currently only be used as an active ingredient for biologicals, export only and prescription medicines and homeopathic formulation in Australia. It is freely sold as a food supplement in USA, Europe and other countries across the globe.
Melatonin pills are available in Australia.
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."
However, it's legal for Australian consumers to bring melatonin into the country without a prescription or to order it from international websites.
Rapid release formulation can also be obtained on prescription from a compounding pharmacy or by crushing the Circadin. Melatonin (Circadin) is now available over the counter for people aged over 55 years. For younger age groups, melatonin tablets need a doctor's prescription in Australia (but not in North America).
Only mild adverse effects, such as dizziness, headache, nausea and sleepiness have been reported. No studies have indicated that exogenous melatonin should induce any serious adverse effects.
Regardless of whether it truly helps with sleep or not, Dr. Ramkissoon doesn't recommend taking melatonin long-term.
Do not use melatonin if you are pregnant or breastfeeding or have an autoimmune disorder, a seizure disorder or depression. Talk to your health care provider if you have diabetes or high blood pressure.
- In the UK, the Medicines Control Agency has banned the high-street sale of melatonin after it was decided the compound was "medicinal by function," and as such requires a drug license. The MCA has written to all relevant suppliers, which comprise mainly health food shops, ordering them to stop selling the product.
Natural alternatives to melatonin, such as magnesium, valerian root, l-theanine, chamomile, and passionflower, are all-natural remedies that have been used for centuries to promote relaxation and help people get a better night's sleep.
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.
All melatonin tablets need a doctor's prescription in Australia (but not in North America). When should you take it? If you take melatonin to go to sleep, the best time (for the slow release type particularly) is about an hour before you go to bed.
There is a range of foods that have high levels of melatonin naturally. These include: cherries, goji berries, eggs, milk, fish and nuts – in particular almonds and pistachios. A goji berry smoothie with almond milk and salmon omelette are some tasty ways to incorporate these sleep-inducing foods into your diet.
Melatonin is not associated with weight gain.
Furthermore melatonin has been shown to have valuable effects on cardiovascular health, blood pressure, and endothelial function and it might benefit patients with heart failure.
In several clinical trials, melatonin was found to be well tolerated and not associated with serum enzyme elevations or evidence of liver injury. Despite wide scale use, melatonin has not been convincingly linked to instances of clinically apparent liver injury.
Suvorexant is the first orexin receptor antagonist to be marketed in Australia. The drug is taken within 30 minutes of bedtime. This should be at least seven hours before the patient plans to get up again. The maximum drug concentration is reached in two hours.
Doxylamine is one of the strongest OTC sleep aids. It is an antihistamine. However, it is only suitable for short-term use. A person should contact a doctor and check that doxylamine is safe for them to use before taking it.
Most people overdo it with melatonin by taking upward of 10 milligrams or more prior to bed and then claim it doesn't work. Taking too much melatonin can actually cause rebound insomnia —either rendering the supplement ineffective or worse, exacerbating your already sleepless nights further.
Sleep deprivation can make this logic seem sound, but experts say taking melatonin in the middle of the night can actually make your sleep schedule even worse.