Following a recent statement by the Icelandic Medicines Agency, Lyfjastofnun, melatonin under a concentration of 1 mg/ day will no longer require a prescription.
Melatonin is a naturally occurring hormone in the body which is released to regulate our sleeping cycles. It is often taken as a dietary supplement and as a medication to treat sleep disorders.
Up until now, melatonin has been classified as a medicine under Icelandic law, regardless of strength. In many other countries, however, melatonin is sold as a dietary supplement and is available without prescription. According to the Icelandic Medicines Agency, these differences in regulation between countries have caused confusion among both Icelanders and tourists, who have purchased melatonin abroad legally, but were not allowed to bring it into the country. In recent years, some of the Nordic countries have decided to allow over-the-counter sale of melatonin in low doses. In other countries, such as the United States, melatonin is sold in higher doses with no prescription needed.
Earlier this year, the Icelandic Food and Veterinary Authority, MAST, requested a reconsideration of melatonin’s classification status. Low-dose melatonin will now be available without prescription, as long as the marketing and packaging makes no claim to treat disease or act as a preventative measure.