Why is Circadin® a prescription-only medicine? Why is Circadin® not available OTC, when other forms of melatonin are available online?

Circadin^® (prolonged-release melatonin) is the first of a new class of drug for insomnia, melatonin receptor activators approved by the regulatory medicines authorities. Circadin^® has been used in multiple clinical trials, showing statistically significant and clinically meaningful efficacy in insomnia parameters ⁶³ .

The food supplements containing melatonin and melatonin pharmacy preparations are not considered medicinal products and therefore are not regulated by the health authorities and have not been adequately tested in clinical controlled studies, their safety is not monitored, and the consumer has no guarantee of their quality.

Circadin^®, as a prolonged-release formulation, has a unique secretion profile that mimics the physiological secretion and profile of melatonin and allows preserving the natural sleep architecture ⁶⁴ . The food supplements containing melatonin and melatonin pharmacy preparations are immediate release products and have not been proven effective and safe in insomnia.