Do You Need a Prescription for Melatonin in Australia?

woman with jet lag can't fall asleep.

Melatonin is a natural sleep hormone that helps regulate your sleep-wake cycle. It’s like the body’s internal clock. In Australia, melatonin is classified as a Schedule 4 prescription-only medicine, so you would need a prescription from a healthcare professional to purchase it. 

In this guide, we explore what melatonin does, its benefits, whether you can buy melatonin without a prescription, and the question on everyone’s mind, “Can I buy melatonin over the counter in Australia”? By the end, you’ll have a clear picture of whether melatonin might be your go-to solution for better sleep and if you need a doctor’s note to give it a try. 

Understanding Melatonin and its Role in Sleep

Melatonin is a natural hormone produced by the pineal gland in your brain, and its primary job is to regulate your sleep-wake cycle. Think of it as the signal telling your body when it’s time to wind down and rest.

Melatonin doesn’t work alone; it responds to the natural rhythm of daylight and darkness. When the sun sets and the lights dim, your body receives the cue to start producing melatonin, signalling that bedtime is approaching. This hormone helps synchronise your internal body clock with the external day-night cycle.

So, why is melatonin so important for a good night’s sleep? Well, it helps to calm your mind and prepare your body for rest. Melatonin levels rise in the evening, making you feel drowsy and ready to embrace the night. Understanding this natural process can shed light on how melatonin supplements or adjustments to your daily routine can positively impact your sleep quality. Whether you’re a night owl or an early bird, grasping the basics of melatonin can empower you to take charge of your sleep patterns and enhance your overall well-being.

Can I Buy Melatonin Over the Counter in Australia?

If you’re wondering where to buy melatonin in Australia, melatonin is available in many places, including pharmacies, health food stores, and even some grocery stores. However, the availability and regulations surrounding its sale can vary depending on the country or region.

In most places where melatonin is sold over the counter, it’s typically marketed as a dietary supplement rather than a pharmaceutical drug. This means it’s not subject to the same rigorous testing and regulation as prescription medications. As a result, the quality and potency of melatonin supplements can vary between brands and products.

Some melatonin gummies and supplements found on the vitamin shelf are homoeopathic preparations. Homoeopathy is a form of alternative medicine that involves highly diluted substances, often to the point where there may be little to no active ingredient remaining. So, if you look at the product label, it won’t have a milligram dosage of melatonin listed. As a result, homoeopathic melatonin products may not contain a significant amount of melatonin, making them ineffective for those seeking the sleep-promoting benefits of melatonin.

It’s essential to exercise caution when using melatonin supplements, especially for individuals with certain medical conditions or those taking other medications. It’s a good idea to consult with a healthcare professional before starting any new supplement regimen, including melatonin.

Woman speaking to pharmacist trying to buy over the counter melatonin

Do You Need a Prescription for Melatonin?

In Australia, melatonin 2 mg modified-release (MR) tablets are the only commercially available product, with other strengths and formulations needing to be prepared by a compounding pharmacist. However, recent regulatory changes have made melatonin 2mg MR tablets available over the counter as a “pharmacist only” medication. This means individuals can purchase these tablets without a prescription, but the sale must be approved by the pharmacist on duty, who assesses the safety and appropriateness of the transaction based on certain criteria.

The criteria for the “pharmacist only” sale of melatonin, as outlined in the Poison Standard, include the following:

  • The melatonin product must be in modified-release tablets containing 2 mg or less of melatonin.

  • It is indicated for monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep.

  • It is specifically intended for adults aged 55 or over.

  • The product should be packaged in packs containing not more than 30 tablets.

If patients do not meet these criteria, they will need to seek a prescription from a healthcare provider if appropriate. The Therapeutic Goods Administration (TGA) has also approved prescription-only child melatonin for use in children between two and 18 with autism spectrum disorder.

Overall, the availability of melatonin without a prescription in Australia is subject to specific regulations and criteria aimed at ensuring safe and appropriate use, particularly for individuals aged 55 or over experiencing primary insomnia. Patients should consult with a pharmacist or healthcare provider for guidance on the use of melatonin and whether it is suitable for their individual needs.

Melatonin Dosage and Safety Guidelines 

Navigating the dosage and safety of melatonin is essential to ensuring its effective and safe use. One common question that often arises in this context is, “Is it OK to take melatonin every night?”

While melatonin is generally considered safe for short-term use, the question of its long-term use is more complex. Some experts suggest that taking melatonin regularly for short periods, such as a few weeks to a few months, may be safe and effective for addressing sleep disturbances. However, the evidence regarding the safety and efficacy of long-term melatonin use is limited.

Taking melatonin every night for an extended period may disrupt the body’s natural production of melatonin, leading to tolerance and dependence. This could potentially diminish the effectiveness of melatonin supplements over time and make it more difficult for the body to regulate its sleep-wake cycle independently.

Moreover, the long-term effects of chronic melatonin supplementation are not well understood, particularly in certain populations such as children, adolescents, and pregnant or breastfeeding women. Therefore, it’s important to exercise caution and consider alternatives for managing sleep difficulties on a long-term basis.

Ultimately, the decision to take melatonin every night should be made in consultation with a healthcare professional, who can provide personalised guidance based on individual circumstances and medical history. Additionally, it’s important to monitor the effects of melatonin use over time and adjust the dosage or frequency of use as needed to optimise its benefits while minimising potential risks.

woman dealing with sleep disorders.

Potential Risks and Side Effects of Melatonin

While melatonin remains relatively safe for many individuals, it’s essential to be aware of potential risks and side effects to ensure responsible use. Here’s what to watch out for when using melatonin:

Daytime Drowsiness

Taking melatonin in excessive amounts or at the wrong time may lead to daytime drowsiness. It’s essential to follow recommended dosages and take melatonin at the appropriate time to avoid disruptions to daily activities.

Interactions with Medications

Melatonin may interact with certain medications, including blood thinners and immunosuppressants. If you are taking any medications, consult your healthcare provider to assess potential interactions.

Allergic Reactions

While rare, some individuals may experience allergic reactions to melatonin supplements. If you notice swelling, itching, or difficulty breathing, seek medical attention immediately.

Impact on Hormone Levels 

Melatonin plays a role in regulating reproductive hormones. Long-term and excessive use of melatonin supplements may affect hormonal balance, particularly in women. Consult with a health professional if you have concerns about hormonal effects.

Sleep-Wake Cycle Disruptions

Paradoxically, melatonin misuse can disrupt the natural sleep-wake cycle (circadian rhythm). Taking melatonin at the wrong time or in excessive amounts may lead to sleep problems, such as difficulty falling asleep or staying asleep.

Gastrointestinal Issues

Some individuals may experience mild gastrointestinal issues, such as nausea or stomach cramps, as a side effect of melatonin use. Adjusting the dosage or taking it with food can help alleviate these symptoms.


There’s limited clinical evidence to suggest that long-term use of melatonin may lead to dependency. It’s advisable to use melatonin as a short-term solution for sleep issues and seek professional guidance for persistent sleep problems or trouble sleeping.

Understanding these potential risks and side effects empowers individuals to use melatonin responsibly. If you experience persistent or severe side effects, consult with a healthcare provider to assess the appropriateness of melatonin for your specific situation.

Consulting a Healthcare Professional for Melatonin

Consulting a healthcare professional for guidance on melatonin usage offers a range of benefits. One common question that often arises is, “Can you take melatonin without asking a doctor?”

While over-the-counter melatonin is available in many places, including pharmacies and health food stores, it’s important to recognise that it is still a potent hormone that can interact with other medications and may not be suitable for everyone. Seeking advice from a healthcare professional before starting sleep medications can help ensure their safe and appropriate use, particularly for individuals with certain medical conditions or those taking other medications.

Healthcare professionals, such as doctors, pharmacists, or sleep specialists, can provide personalised guidance based on an individual’s medical history, current medications, and specific sleep disorders or concerns, such as chronic insomnia. They can help determine whether melatonin is the right option for addressing sleep difficulties and can recommend an appropriate dosage and regimen based on the individual’s needs.

Additionally, healthcare professionals can help monitor the effects of melatonin use over time and make adjustments as needed to optimise its benefits while minimising potential risks. They can also provide information on lifestyle and behavioural changes that can complement melatonin supplementation for improving sleep quality.

telehealth consult for melatonin supplement

Alternatives to Melatonin

For those seeking alternatives to melatonin, several non-melatonin natural health products offer potential solutions to fall asleep and stay asleep. Herbal supplements such as valerian root and chamomile have gained popularity for their calming effects and ability to promote relaxation before bedtime. Valerian root, in particular, is believed to enhance the production of gamma-aminobutyric acid (GABA), a neurotransmitter that helps regulate anxiety and stress. 

Incorporating relaxation techniques like meditation, deep breathing exercises, or yoga into your bedtime routine can naturally signal to your body that it’s time to wind down. The use of white noise machines or calming music can also create a calming sleep environment, and practising good sleep hygiene is beneficial. Exploring these non-prescription alternatives provides individuals with a variety of options to find the approach that best suits their preferences and promotes restful sleep without the need for melatonin supplementation.

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