From the Guidelines
No, melatonin cannot be purchased over-the-counter (OTC) in England. According to the most recent evidence from 2023, melatonin requires a prescription in the European Union and the United Kingdom 1. This is in contrast to countries like the United States and Canada, where melatonin is available OTC as a dietary supplement. The prescription status of melatonin in the UK exists to ensure appropriate medical supervision of its use, as it can interact with certain medications and may not be suitable for everyone.
Some key points to consider:
- Melatonin is used to treat conditions like isolated REM sleep behavior disorder (RBD), with a typical starting dose of 3 mg taken at bedtime, which can be titrated up to 15 mg as needed 1.
- The use of melatonin is subject to fewer governmental regulations and scrutiny in countries where it is available OTC, which may affect its bioavailability and content across different formulations 1.
- In the UK, it is advisable to consult with a GP if experiencing sleep problems, as they can assess the condition and prescribe melatonin if appropriate, or suggest alternative treatments for insomnia such as improved sleep hygiene or other interventions.
It is essential to prioritize medical supervision when using melatonin, especially considering its potential interactions with other medications and its suitability for individual patients. Therefore, it is not recommended to attempt to purchase melatonin OTC in England, and instead, patients should consult with a healthcare professional for proper evaluation and treatment.
From the FDA Drug Label
PRINCIPAL DISPLAY PANEL - Vitamin Bottle Label Safrel Melatonin 3mg Tablets: Helps establish normal sleep patterns 100%Drug-free and non-habit forming melatonin is a nighttime sleep aid for occassional sleeplessness.VeganFast Dissolve DIETARY SUPPLEMENT Melatonin 3mg Tablets 60 Count Melatonin 3mg Tablets 90 count The FDA drug label does not answer the question.
From the Research
Availability of Melatonin in England
- Melatonin is widely available either on prescription for the treatment of sleep disorders or as an over-the-counter dietary supplement 2.
- In the UK, melatonin has been licensed for the short-term treatment of jetlag, indicating its availability over-the-counter for specific purposes 2.
- There is no direct evidence in the provided studies to suggest that melatonin cannot be purchased over-the-counter in England, but its availability might be subject to specific regulations or licensing for certain conditions.
Regulatory Considerations
- The studies provided focus on the efficacy, safety, and therapeutic uses of melatonin rather than its regulatory status in England 3, 4, 5, 6.
- The licensing of melatonin in the UK for the short-term treatment of jetlag implies that there are regulatory frameworks in place that govern its sale and use 2.
Conclusion on Availability
- Given the information available, it appears that melatonin can be purchased over-the-counter in England, at least for certain conditions like jetlag, but the extent of its availability might depend on the specific product and its intended use 2.