In December 2025, the EMA recommended the authorization of Melatomed, a prolonged-release melatonin tablet, in Germany, Austria, Denmark, and Sweden, expanding the availability of melatonin-based treatments in the EU. (ema.europa.eu)
In May 2025, melatonin prices in the United States reached approximately $86,551 per metric ton, reflecting strong pharmaceutical and nutraceutical demand, alongside steady production costs. Limited raw material availability and ongoing regulatory adjustments contributed to this price trend.
In July 2023, the WHO published the 23rd edition of its Model List of Essential Medicines, which did not include melatonin, indicating that it is not considered essential for priority healthcare needs globally. (test-cms.who.int)
In September 2024, the WHO emphasized the importance of essential medicines being available, affordable, and of assured quality at all times, highlighting the need for countries to develop and update national essential medicine lists. (test-cms.who.int)
In December 2025, the EMA completed a review of Melatomed following a disagreement among EU Member States regarding its authorization, concluding that the benefits of Melatomed outweigh its risks, and that the marketing authorization can be granted in the concerned Member States. (ema.europa.eu)
