Is Over-the-Counter Melatonin Legal in the UK?

Much of the population struggles with sleep including falling asleep and staying asleep. Therefore, to manage these symptoms including symptoms of jet lag, reduced sleep hours, and insomnia, many people use melatonin supplements.

However, Melatonin is not available in the United Kingdom as an over-the-counter medication (OTC). At the moment, Melatonin can only be prescribed by an appropriate healthcare professional who can legally prescribe and write prescriptions hence can only be bought as a prescription only medication (POM).

It is recommended to only obtain Melatonin in the UK using the correct method by going to your General Practice (GP) or calling 111 or another appropriate clinical pathway and obtaining a legal prescription for Melatonin. Several online pharmacies also can conduct video calls in order to assess your need for Melatonin and hence prescribe a legal prescription for Melatonin which can then be delivered to your house.

Both the National Health Service (NHS) and regulators in the UK advise against buying Melatonin from suppliers that have not been regulated or are selling Melatonin online without being transparent about their regulatory or manufacturing process.

What Is Melatonin and How Does It Work?

Insomnia is a common condition where nearly one third of adults from western countries struggle with falling or staying asleep. Insomnia can occur at any point in an individual’s life but tends to be more common in older people as insomnia worsens with age. Symptoms include tiredness, extreme fatigue, low or even a depressed mood, irritation and issues with cognition.

People who tend to have comorbidities or chronic health conditions such as heart problems, chronic pain, drug addiction, chronic obstructive pulmonary disease (COPD) and so on tend to struggle with insomnia the most.

There are several medications for sleeplessness such as Melatonin which is considered a safe insomnia treatment and for minor sleep disturbances to help regulate an individual’s sleep-wake cycle. Many clinical trials show that melatonin reduces the time it takes to fall asleep (sleep latency) and hence increases the time spent sleeping by a decent amount.

Melatonin is an endogenous sleep hormone that is naturally produced by the human body. It is produced and released in the pineal gland. It acts on the suprachiasmatic nucleus of the hypothalamus and also the retina and hence regulates the body’s sleep-wake cycle. It therefore is extremely important in regulating our circadian rhythm, also known as our internal ‘body clock’. Melatonin is produced and released during late hours during the night which helps to induce sleep and tends to fall during the day (morning light exposure).

Melatonin synthesis occurs in two main stages: tryptophan is first converted into serotonin in different regions of the brain via a pathway. Serotonin produced also acts on the pineal gland and via a cyclic process which is mediated by external light, serotonin gets converted to melatonin. Melatonin inhibits wakefulness by acting on MT1 and MT2 receptors hence promotes sleep.

• MT1 receptors: regulate and induce sleep
• MT2 receptors: are useful when an individual has jet lag or has a delayed sleeping and waking dysfunction.

Melatonin is also commonly prescribed for children and younger adults with autism or attention deficit hyperactivity disorder (ADHD) which can cause disruptions with sleep. Therefore, a good treatment plan and monitoring can greatly reduce these symptoms and increase quality of life.

Can You Buy Melatonin in the UK?

Melatonin cannot be purchased in the UK without a legal prescription provided by an appropriate prescribing healthcare professional. This could be a clinician, an independent prescribing pharmacist and others. Melatonin is a prescription only medication (POM) in the UK therefore, it will not be sold as a supplement in any pharmacies or grocery shops as it would need a legal prescription to be dispensed from an appropriate community or hospital pharmacy.

There are some websites which sell Melatonin 3mg designed for treating jet lag however, it requires a questionnaire to be filled out which asks specific questions. The answers are then carefully assessed and only then the medication can be purchased online. This is however not available on the NHS and is only sold as a short term solution for jet lag relief therefore you would be required to pay in order to purchase these tablets.

Furthermore, although some websites may sell Melatonin like the one above for treating symptoms such as jet lag, it is not advised to buy Melatonin online without a legal prescription as it may be deemed unsafe for use. The Medicines and Healthcare products Regulatory Agency (MHRA) regulate the production and sales of medications therefore have taken enforcement actions against sellers who sell melatonin illegally.

This is especially important as non-regulated Melatonin can be extremely harmful as there is no way of knowing how much concentration of the product is in the supplements. Some quality assurance studies have shown that some Melatonin supplements contain less than 1% of the concentrated drug whereas some contain more than 200% and are sometimes even contaminated with other drugs.

Is Melatonin Legal in the UK?

Melatonin is legal in the UK however, this is only when melatonin is legally prescribed by an appropriate prescribing clinician, independent pharmacy prescriber or any other healthcare professional with the right to legally prescribe medications including Melatonin.

Under the NHS guidance on Melatonin, it is not legal in the UK to be purchased over-the-counter or to be sold with a legal prescription which includes buying it online off random websites.

This is extremely important to ensure that only the patients that require melatonin are using it and the doses are being carefully monitored and assessed by an appropriate clinician to ensure the drug will not cause any harm or severe side effects due to drug abuse.

Therefore, to further clarify, melatonin is not banned in the UK however, it is under strict regulations regarding its usage and sales. It is treated like any other normal prescription medications which need a legal prescription signed by a doctor or appropriate prescriber in order to be dispensed.

Why Melatonin Is Restricted in the UK

Melatonin is restricted in the UK because it is classed as a prescription only medication (POM) therefore it can only be prescribed legally by a qualified prescribing clinician and dispensed by a qualified and registered pharmacist. This is in accordance with the Human Medicines Regulations 2012 Act therefore not following these guidelines can lead to severe legal consequences.

These guidelines are furthermore enforced by the Medicines and Healthcare products Regulatory Agency (MHRA) which are important as they ensure that the product is of high quality, is safe for use and has been clinically tested and reviewed for patient use.

Buying melatonin online or in person from unknown suppliers can run the risk of harm by taking unregulated Melatonin supplements. The supplements could have high concentrations of the drug and could also be contaminated and laced with other medications. Furthermore, the risks of taking Melatonin long term are still unknown. Since they are unregulated, there is no way to check what, if any, safety guidelines have been followed and whether they are fit for human consumption.

This could lead to worsening of symptoms and cause more sleep related complications and could especially be harmful if given to young children without the supervision of a healthcare professional. Therefore, by ensuring strict policies regarding sale and use of unregulated medications, the UK prioritises patient safety and wellbeing and this should be adhered to.

Alternatives to Over-the-Counter Melatonin

Lifestyle and Sleep Hygiene Tips

Therefore are several lifestyles factors that can be incorporated to improve sleep cycle regulation and maintain better sleeping habits and these are detailed below:

• Stick to a fixed sleeping schedule even if you only sleep for a few hours. This means try to aim to sleep at the same time and wake up at the same time each day. Stick to this all seven days a week
• Keep your curtains and blinds open where appropriate in the early hours of the day so that you wake up naturally with natural light exposure
• Reduce the time spent on your phone or any electronic devices before sleep
• Switch your devices to dark mode which reduces harsh lights if using during late hours to reduce the impact of blue light on sleep
• Keep your sleep area separate from your work area or your dining area so you can ensure a good night’s sleep with minimal stress as the brain can associate certain areas of your living space with stress.
• Avoid drinking coffee or any stimulants such as energy drinks or even alcohol close to bed time

There are countless studies which show the benefits of managing and maintaining your sleeping habits also known as good sleep hygiene. However, in cases where the above is not sufficient, it is important to reach out to your doctor so a treatment plan can be curated to help you with your sleep problems. This can be done using sleep hygiene techniques combined with cognitive behavioural therapy (CBT), chronotherapy and even prescription therapy medications.

Natural Supplements for Better Sleep

There are several supplements which can be used as alternatives to melatonin to improve your quality of sleep and these are listed below and are detailed further on Meds for Less. However, these are only for short term use therefore if you struggle with sleeping for over a long period, it is best discussed with your GP or another healthcare provider.

The following natural supplements can be bought over-the-counter in the UK so ensure to look for products which contain the following ingredients (not all in one):

• Valerian root
• Magnesium
• Chamomile
• Lavender
• Passionflower
• Glycine
• Cannabidiol (CBD)

If you are taking other synthetic medications (OTC or POM) then ensure to only take natural sleep remedies under the supervision of a doctor. This is because herbal remedies could interact with other medications and lead to harmful side effects.

When Prescription Options Are Needed

Prescription options may be required if you struggle with sleeping despite trying to maintain good sleep hygiene and if you have tried other natural sleep remedies OTC. If you still struggle with sleep problems then you may require medical assistance and possibly stronger medications to help induce sleep.

The following described some treatments which are commonly prescribed for sleep disorders:

• Melatonin – available in tablets, capsules, liquid and spray formulations
• Sedative medications such as Zolpidem or Zopiclone – only used short term to address sleep problems. Run a high risk of drug dependence.
• Cognitive Behavioral Therapy (CBT) – addressing any underlying anxiety, depression, low mood and general wellbeing and mental health
• Chronotherapy or light therapy to treat sleep disorders.
• Addressing underlying health issues such as anxiety, depression, sleep apnea which could be causing the sleep disturbances.

Melatonin Availability in the UK vs Other Countries

Melatonin is available over the counter in other countries which is why many patients become confused about where to get Melatonin in the United Kingdom (UK). To answer the question: can you get melatonin over the counter in the uk, the following table shows a comparison of the different laws and regulations regarding Melatonin availability in different countries:

Therefore, melatonin sales in the UK are regulated under the European standards, so it is recommended to only access melatonin via a legible prescription from your GP or healthcare provider. Unfortunately, certain non-UK websites do sell melatonin online.

However, to avoid confusion, it is important to distinguish as to whether these are being sold in the EU or in other countries such as America where melatonin can be purchased in high strength over-the-counter.

When to Speak to a Doctor About Sleep Issues

Struggling with sleeping once in a while is not a cause for concern but can be managed with better sleeping habits. However, sometimes it may require careful intervention therefore, you should speak to your doctor if you struggle with any of the following symptoms alongside sleeplessness:

• You are struggling with falling or staying asleep for more than 3 months (chronic problem)
• You have been told or are aware about snoring heavily at night, struggling with breathing difficulties or you stop breathing in your sleep (sleep apnea)
• You may be dealing with another underlying health condition which you may not may not be aware of such as depression, anxiety
• You have tried several over-the-counter and herbal remedies and tried to improve your sleeping habits but nothing seems to work.
• You are unable to function well during the day due to lack of sleep and it is affecting your daily life and impacting your relationships.
• You are waking up many times during the night
• You struggle to sleep and you get anxiety over the hours of sleep you are losing (this can cause more anxiety and make it difficult to fall asleep)
• You feel more irritated than normal in your daily life.

If you struggle with any of the above or any other symptoms that you believe may be impacting your quality of sleep, it is highly recommended to reach out to your GP to ensure that this can be managed as soon as possible.

Lack of sleep can lead to many comorbidities and also cause lasting damage in your personal and social settings. Driving and operating heavy machinery without efficient sleep can put you and others at risk.