Ruqayyah Snyder
Melatonin is a natural sleep-inducing hormone that helps regulate the sleep-wake cycle. It is produced in response to darkness and helps the body maintain its internal 24-hour clock or circadian rhythm. While melatonin is available over the counter in the United States, its legality in Australia has been a topic of discussion in recent years. In 2021, there were media reports that melatonin would become an over-the-counter medication in Australia, but as of 2022, it remains a prescription-only medicine in the country.
| Characteristics | Values |
|---|---|
| Availability in Australia | Available over the counter for people aged 55 or above. |
| Dosage | 2mg tablets, limited to one box of 30 per month. |
| Alternative | Homeopathic melatonin, which is immensely watered-down. |
| Availability for children | Medicine containing 1mg modified-release melatonin has been approved for use in children up to 18. |
| Schedule 3 classification | Approved for monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients aged 55 or above. |
| Schedule 4 classification | Not affected by the final decision to amend the current Poisons Standard in relation to melatonin. |
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What You'll Learn
- Melatonin is available over the counter in Australia for people aged 55 or over
- It is a natural sleep-inducing hormone that helps regulate the sleep/wake cycle
- It is non-addictive, unlike synthetic sleeping pills
- It is available in different forms, such as tablets, caplets, drops, and soft chewable gummies
- There are concerns about the quality control of over-the-counter melatonin products
Melatonin is available over the counter in Australia for people aged 55 or over
Melatonin is a hormone that helps regulate the body's sleep/wake cycle, also known as the circadian rhythm. It is produced in response to darkness, with its synthesis and secretion predominantly occurring at night between about 9 pm and 8 am. While melatonin is a natural substance, its long-term effects on physical and psychological well-being are still unknown.
In Australia, melatonin has been the subject of recent changes in its availability. As of 2024, melatonin is now available over the counter for individuals aged 55 or above. However, access is restricted to 2mg tablets, limited to one box of 30 per month, with a cost of upwards of $30. This change was implemented after media reports in 2021 indicated that melatonin would become an over-the-counter medication.
Prior to this change, melatonin was not available over the counter in Australia and was regarded as a prescription medicine. The decision to make melatonin available over the counter was made by the Therapeutic Goods Administration (TGA), with the approved indication for short-term treatment of primary insomnia characterised by poor-quality sleep in patients aged 55 or above.
It is important to note that the quality of over-the-counter melatonin products can vary significantly. Studies have shown that the melatonin content in these products can vary from -83% to +478% of the labelled amount, with 70% containing ≤ 10% of the claimed amount. Additionally, more than a quarter of melatonin products were found to contain serotonin, which could have medicinal effects and should be used under supervision. Therefore, consumers should exercise caution when purchasing and using over-the-counter melatonin products.
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It is a natural sleep-inducing hormone that helps regulate the sleep/wake cycle
Melatonin is a natural sleep-inducing hormone that helps regulate the sleep/wake cycle. It is produced in response to darkness and is responsible for maintaining the body's internal '24-hour clock' or circadian rhythm. The body's production of melatonin occurs predominantly at night between 9 pm and 8 am, with secretion being higher during periods of darkness.
While melatonin is a natural substance, its long-term effects on physical and psychological well-being are not yet fully understood. There is also a lack of knowledge about the toxicity of exogenous melatonin, which makes self-prescription and self-administration potentially risky.
In Australia, melatonin has been approved for the short-term treatment of primary insomnia in adults aged 55 and above. It is available 'over the counter' for this specific age group, with a dosage limit of 2 mg or less. However, there are limited options for over-the-counter melatonin, and the available products are typically in the form of meagre 2 mg tablets, restricted to one box of 30 per month.
For those seeking alternatives, homeopathic melatonin is available off the shelf. However, these products are highly diluted, and the amount of melatonin they contain is unclear. Australian consumer watchdog Choice has warned against the ineffectiveness of homeopathic melatonin, stating that there is no reliable evidence of its impact beyond a placebo effect.
While melatonin is a natural hormone, its regulation as a medicine in Australia underscores the importance of understanding its potential risks and side effects.
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It is non-addictive, unlike synthetic sleeping pills
Melatonin is a natural hormone produced by the body in response to darkness, helping to regulate the sleep/wake cycle and keep our internal '24-hour clock' ticking. While melatonin is produced predominantly at night, it is not produced during casual darkness during the day or when we sleep during the day.
In Australia, melatonin has been approved for the short-term treatment of primary insomnia in adults aged 55 and over. It is available 'over the counter' but only in 2mg tablets, limited to one box of 30 per month, and for a cost of upwards of $30.
The alternative is homeopathic melatonin, which is watered down to the point where it is considered useless. Melatonin is also available in sugar-free liquid formulas, chewable 'gummies', drops, and caplets.
While there is a lot we still don't know about the function of melatonin, one thing we do know is that it is non-addictive. This is in contrast to synthetic sleeping pills, which can be addictive. Melatonin is a natural substance, and the body is already programmed to respond quickly to it. It is a safer option than the chemicals of synthetic sleeping pills, which can be addictive and have other side effects.
There is a large global market for melatonin, with sales in the United States increasing by more than 500% between 2003 and 2014. However, the quality control of over-the-counter melatonin has been called into question, with the actual melatonin content varying greatly from what is listed on the label. In addition, more than a quarter of melatonin products contain serotonin, which should not be taken without oversight.
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It is available in different forms, such as tablets, caplets, drops, and soft chewable gummies
Melatonin is a natural sleep-inducing hormone that helps regulate the sleep/wake cycle, or the body's '24-hour clock'. It is available over the counter in Australia for people aged 55 or over, in the form of 2mg tablets, limited to one box of 30 per month.
For those seeking an 'off the shelf' alternative, homeopathic melatonin is available. However, the concentration of melatonin in these products is unclear and they are widely considered to be ineffective.
Melatonin is also available in different forms, such as tablets, caplets, drops, and soft chewable gummies. Tablets and caplets are the most common forms of melatonin supplements. Tablets are typically swallowed whole with water, while caplets are designed to be absorbed under the tongue, providing faster absorption and effectiveness. Drops are another option for those who prefer not to swallow pills. They are usually placed under the tongue or added to a beverage. Soft chewable gummies are also a popular choice, especially for those who find tablets difficult to consume. These gummies are designed to be chewed and come in various flavours to make the experience more enjoyable.
The variety of forms available ensures that individuals can choose the most suitable option for their needs and preferences. However, it is important to note that the effectiveness and concentration of melatonin can vary significantly between different products and brands. Some products may contain significantly less or more melatonin than advertised, as highlighted by studies on over-the-counter melatonin supplements. Therefore, consumers should be cautious and carefully review the ingredients and concentrations listed on the product labels.
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There are concerns about the quality control of over-the-counter melatonin products
Melatonin is a hormone produced by the body to regulate its sleep/wake cycle. It is also available in synthetic form as a supplement to help with sleep issues. While melatonin is available over the counter in the United States, it is a prescription drug in other parts of the world.
In Australia, melatonin is available over the counter but only to people aged 55 or over. The over-the-counter product is a homeopathic melatonin that is immensely watered down. The actual melatonin content in these products is unclear, with labels featuring meaningless marketing terms like '4x' or '6x'. Australian consumer watchdog Choice gave a 'Melatonin Homeopathic Sleep Formula' a Shonky award, stating that there is "no reliable evidence that homeopathic melatonin has any effect other than as a placebo".
Outside of the over-the-counter products, melatonin is available in Australia by prescription. However, there are concerns about the quality control of over-the-counter melatonin products. A 2017 study found that the melatonin content in these products varied from -83% to +478% of the labelled melatonin content, with 70% of products containing ≤ 10% of the claimed melatonin. The most variable sample was a chewable tablet, which contained 9 mg of melatonin when it was supposed to contain 1.5 mg. The study also found that the melatonin content between lots of the same product varied by as much as 465%.
The above-mentioned study also found that more than a quarter of melatonin products contained serotonin, which could have medicinal effects and should not be taken without oversight. There is also the risk of night-to-night variability in dose, which could lead to unexpected side effects, particularly for those who are sensitive to melatonin, pregnant, allergic to impurities, or have diabetes/prediabetes.
The large variability in melatonin levels between subjects, as well as the unknown long-term consequences of tampering with the body's biological timing system, are further reasons for concern when it comes to the quality control of over-the-counter melatonin products.
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Frequently asked questions
No, melatonin is not illegal in Australia. However, it is available over the counter only to people aged 55 or over, and even then, the dispensary will give only 2mg tablets, limited to one box of 30 per month, for upwards of $30.
Melatonin is a natural sleep-inducing hormone produced in response to darkness. It helps regulate the sleep/wake cycle, or the internal '24-hour clock', by fine-tuning the body's biological timing system.
Melatonin is not outlawed in Australia but regarded as a medicine, available only by prescription. This is due to concerns about the unknown long-term consequences of tampering with the body's biological timing system and the potential for poor quality control in over-the-counter melatonin supplements.
While some people have reported buying melatonin online from international sellers and having it shipped to Australia, it is unclear whether these products would be seized by customs.
