
Melatonin is a naturally occurring hormone that helps regulate the sleep-wake cycle. It is produced by the pineal gland in the brain. In many countries, melatonin is available over the counter as a dietary supplement, but its status varies in Australia. While melatonin is available over the counter for people over 55, it is prescription-only for those under 55. The Therapeutic Goods Administration (TGA) has approved prescription melatonin for children with autism spectrum disorder, but it is not available over the counter for children. As a result, some parents are buying melatonin products from overseas, but this practice has raised safety concerns.
| Characteristics | Values |
|---|---|
| Availability in Australia | Available with a prescription for people under 55. Available over the counter for people 55 and older. |
| Availability for children | Available with a prescription for children between two and 18 with autism or other developmental disabilities. |
| Availability over the counter | Only homeopathic formulations are sold over the counter in Australia. |
| Availability in other countries | Treated as a food supplement and sold over the counter in many countries, including the US. |
| Buying from international websites | Legal for Australian consumers to order melatonin from international websites. |
| Buying from international suppliers | Legal to buy melatonin from overseas suppliers and bring it into the country without a prescription. |
| Regulation of international websites by TGA | No. |
| Regulation of international suppliers by TGA | No. |
| Safety | Generally safe, but rare side effects include night terrors, irritability, nausea, stomach pain, headache, and drowsiness the following day. |
| Effectiveness | Safe and effective, but no long-term studies involving children have been conducted. |
| Advice for parents | Assess sleep hygiene, including the bed, covering, sleep attire, room temperature, and amount of light in the bedroom. |
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What You'll Learn
- Melatonin is available over the counter in Australia for people over 55
- A prescription is required for people under 55
- Melatonin is not banned in Australia, but it is illegal to import it without a prescription
- Melatonin is a naturally-occurring hormone that can help control your sleep cycle
- Melatonin is available in Australia, but some people buy it from overseas

Melatonin is available over the counter in Australia for people over 55
Melatonin is a naturally occurring hormone produced by the brain after dark that helps regulate the sleep-wake cycle or body clock. It is commonly used to treat sleep disorders, particularly in children with autism or other developmental disabilities. While melatonin is available over the counter in some countries, its availability is more restricted in Australia.
In Australia, melatonin is available over the counter for people aged 55 and above. For those under 55, a prescription is required. The Therapeutic Goods Administration (TGA) has approved prescription-only melatonin for use in children between the ages of two and 18 with autism spectrum disorder. Melatonin is also available over the counter in Australia as a homeopathic formulation. However, it is important to note that the TGA has not evaluated the safety or efficacy of melatonin gummies for broader use in this age group.
While melatonin is generally considered safe, there have been reports of children experiencing adverse reactions. A sleep psychologist and a paediatric and adolescent sleep specialist have cautioned against treating melatonin as a "sleep candy" and recommended that it be prescribed by a doctor and monitored for side effects. There are also concerns about the variability in the quality and purity of over-the-counter melatonin sold internationally, as highlighted by a 2017 study.
It is important to consult a doctor or pharmacist to determine if melatonin is suitable for you and to discuss potential interactions with other medications. Melatonin should not be taken with sedatives, antidepressants, or alcohol, and it is not recommended for those who are pregnant or breastfeeding. While melatonin can be helpful for short-term sleep issues, long-term sleep problems may require further medical investigation and other treatment options.
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A prescription is required for people under 55
Melatonin is a naturally occurring hormone that helps control the sleep-wake cycle in humans. It is produced by the pineal gland in the brain, and its levels vary throughout the day and night. Typically, melatonin levels increase about two hours before sleep, getting the body ready to wind down.
In many countries, melatonin is treated as a food supplement and is available over the counter. However, in Australia, melatonin is a prescription medication for people under the age of 55. This means that anyone under 55 wishing to use melatonin must first consult a doctor or pharmacist to obtain a prescription.
The Therapeutic Goods Administration (TGA) has approved prescription-only melatonin for use in children between the ages of two and 18 with autism spectrum disorder or other developmental disabilities. Melatonin supplements have been shown to help autistic children fall asleep faster and sleep for longer. However, it is important to note that melatonin should always be prescribed and administered to children under medical supervision as a last resort. While melatonin is generally considered safe, there have been reports of children experiencing adverse reactions and side effects such as night terrors, irritability, nausea, and drowsiness.
Although it is illegal to import prescription medication into Australia without a script, some parents have resorted to buying melatonin supplements from overseas websites due to the ease of access and quick delivery. However, the TGA advises caution when purchasing medicines online, as these products may not meet Australian quality standards and could contain undisclosed harmful ingredients.
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Melatonin is not banned in Australia, but it is illegal to import it without a prescription
Melatonin is a naturally occurring hormone that helps control the sleep-wake cycle. It is produced by the pineal gland in the brain and its levels vary throughout the day and night. Typically, melatonin levels increase about two hours before going to sleep, getting the body ready to sleep.
In Australia, melatonin is available over the counter for people aged 55 and above for the short-term treatment of primary insomnia. However, for individuals under the age of 55, a prescription is required. This includes children between the ages of two and 18 with autism spectrum disorder or other developmental disabilities, who must be prescribed melatonin by a GP or paediatrician.
While melatonin is not banned in Australia, it is illegal to import it without a prescription. The Therapeutic Goods Administration (TGA) has warned consumers against purchasing medicines, including melatonin, from international websites, as these products are not regulated by the TGA and may not meet Australian quality standards. Moreover, the TGA has expressed concern about the potential for misuse by consumers and the risk of underlying sleep conditions not being properly diagnosed or managed, especially in children.
Despite the challenges associated with importing melatonin, some Australian parents have resorted to buying melatonin supplements from overseas without a prescription to help their sleep-deprived children. This is due to the ease and convenience of online purchases, as well as the perception that melatonin is a safe and effective solution for sleep problems. However, it is important to note that melatonin should be treated as a medication and not as a "sleep candy".
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Melatonin is a naturally-occurring hormone that can help control your sleep cycle
Melatonin is commonly used in supplement form to help children and adults with sleep disorders. In many countries, melatonin is treated as a food supplement and sold over the counter. This includes the US, where melatonin is the fourth most popular "natural product" taken by adults and the second most popular for children. In Australia, melatonin is available over the counter for people aged 55 and above for the short-term treatment of primary insomnia. However, a prescription is required for any supply of melatonin for people under 55.
In Australia, melatonin is also prescribed as a medication for children between the ages of two and 18 with autism spectrum disorder or other developmental disabilities. While melatonin is generally considered safe, there have been no long-term studies involving children. There is also a concern about the broader ability of this formulation to be used in children. In 2021, there were 2,000 calls about children having an adverse reaction to melatonin. Rare side effects of melatonin include night terrors, irritability, nausea, stomach pain, headache, and drowsiness the following day.
Although melatonin is available over the counter in some countries, it is illegal to import prescription medicine into Australia without a script. The Therapeutic Goods Administration (TGA) has warned that products that are not regulated by the TGA may not meet Australian manufacturing quality standards and could contain undisclosed harmful ingredients.
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Melatonin is available in Australia, but some people buy it from overseas
Melatonin is a naturally occurring hormone that helps control the sleep-wake cycle in humans. It is produced by the pineal gland in the brain and its levels vary throughout the day and night, with higher levels at night and lower levels during the day. Melatonin is commonly used to treat short-term sleep problems or to reset the body clock after shift work or jet lag. While melatonin is available in Australia, it is regulated as a prescription-only medication for individuals under the age of 55. This means that a doctor's prescription is required to obtain melatonin in Australia for those under 55.
However, in some other countries, such as the United States, melatonin is treated as a food supplement and is available over the counter. This has led to a growing number of people in Australia, particularly parents of sleep-deprived children, resorting to buying melatonin supplements from overseas suppliers without a prescription. They cite the ease and convenience of online purchasing, as well as the difficulty in accessing a doctor or pharmacist, as reasons for their decision. It is important to note that while it is legal to buy melatonin from overseas and bring it into Australia without a prescription, the Therapeutic Goods Administration (TGA) advises consumers to exercise extreme caution when purchasing medicines, including supplements, over the internet.
The TGA warns that products not regulated by them may not meet Australian manufacturing quality standards and could contain undisclosed harmful ingredients. There have been concerns about the variable quality and purity of over-the-counter melatonin sold in other countries, with studies finding incorrect dosages and concentrations in many supplements. Additionally, the TGA emphasizes that children suffering from any medical condition should be seen by a doctor and not given medicines purchased from the internet.
In Australia, melatonin is available through prescription for individuals under 55 and over-the-counter for those aged 55 and above. It is important to consult a healthcare professional before taking melatonin to ensure safe and effective usage, as it may interact with other medications and is not suitable for everyone. While it may be tempting to buy melatonin from overseas due to its easier accessibility, it is crucial to prioritize safety and follow the recommendations of the TGA to protect your health and well-being.
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Frequently asked questions
No, melatonin is not banned in Australia. However, it is a prescription-only medication for people under the age of 55.
Melatonin is available in Australia with a doctor's prescription for people under 55. For those over 55, it is available over the counter.
Melatonin is not recommended for children unless prescribed by a doctor. It is illegal to import prescription medicine without a script and melatonin products available on international websites are not regulated by the Therapeutic Goods Administration (TGA).
The TGA has expressed concerns about the risk of misuse by consumers, the potential for underlying sleep conditions not being diagnosed or managed, and the potential for interaction with other drugs.
Melatonin is available over the counter in Australia for people over 55. However, the only melatonin products sold over the counter are homeopathic formulations.











































