Thee Therapeutic Goods Administration (TGA) (Australia’s government authority that regulates medicines, medical devices, and biologicals) has tested several brands of Melatonin sourced from online suppliers and found that the quantity of active material (Melatonin) can vary significantly from the listed dosage. This range was from 0% to 400%, which is significant. The TGA urges people to purchase local, where pharmacies need to sell products that are better regulated. This does not address the difficulty in being scripted Melatonin if you you under 55 years of age, or the cost if you need more than 2 mg per tablet.
The TGA has named and shamed some of the products that they have tested that varied in dose strengths. This is the list of products that the TGA tested that varied – there indication of what products were correct and no statement that I could find that these were all that they tested – that is, if your product isn’t listed here, that doesn’t mean it is fine.
The variations in supplied range compared to the listed dose begs the question – if the manufacturer of this product has lied about the most important component, what else did they lie about? This can be vital for people with allergies. Personally, I am gluten intolerant and can become sick for a week and a half if I consume gluten. Gluten is a common filler product in medications. While some brands claim to be “gluten free”, if they can’t even get the dose of the primary product right, how much can I trust that they don’t actually contain gluten?
The TGA reminds Australian Citizens that “Consumers are advised that melatonin is a prescription-only medicine in Australia, except in specific circumstances for adults.” That circumstance is if you are 55 years of age or older, you can purchase Melatonin over the counter.
It is also important to note the RACGP’s warning that Melatonin is not safe for children under 12 months of age and paediatricians should be consulted for children who are having difficulty with sleep. Melatonin may be helpful for children older than 1, in consultation with your doctor, especially if the child is diagnosed with Autism and or ADHD, or is likely to be diagnosed when assessed.
A common reason why people are going to the internet to purchase Melatonin is that only 1 or 2 mg doses are available in Australia from the pharmacy, where ADHDers frequently need 5 mg to 15 mg doses. Many doctors prefer to prescribe medications like mirtazapine, benzodiazepine or seroquel for sleep assistance, which are far more “hard core” than Melatonin when Melatonin can do the job adequately well – there are no recorded deaths world wide from a Melatonin overdose, which can’t be said for these other products.
We have a page on Beating Insomnia, where we explore non-medicated methods to manage sleep difficulties, and Beating Pre-Sleep Anxiety where we look at why you might be struggling with a certain type of sleep.