'EU Clears Generic Sleep Aid for Seniors With Insomnia'

 A generic melatonin product, Melatomed (Fairmed Healthcare GmbH), has received positive recommendation for managing sleep disorders in adults 55 years or older from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP).

The agency determined that Melatomed shows adequate bioequivalence to its reference medicine and offers benefits that exceed its risks. The product will be eligible for national marketing authorizations in Germany, Austria, Denmark, and Sweden.

Slow‑Release Sleep Treatment 

Melatonin is a naturally occurring hormone that the body produces to coordinate sleep cycles by acting on cells in specific brain regions to promote sleep onset. The slow-release Melatomed formulation delivers melatonin gradually over several hours, targeting brief management of primary insomnia in patients without identifiable medical, mental, or environmental causes for their sleep difficulties.

Melatomed was developed as a generic version of Circadin, an already authorized European Union reference medicine containing the same active substance. The company submitted the application through a decentralized procedure, where Germany served as the reference Member State to assess the medicine for authorization across multiple countries, including Austria, Denmark, and Sweden.

Bioequivalence Concerns and Resolution 

The Member States could not reach agreement after Sweden raised concerns that the data provided by the company failed to demonstrate that Melatomed is bioequivalent to Circadin, meaning the active substances from both medicines might not be absorbed in the body at the same rate and extent. 

The company provided data from two single-dose studies measuring medicine absorption over time using area under the curve (AUC) measurements, conducted both on empty stomach and after eating. When taken with food, the AUC for later time intervals fell outside acceptable bioequivalence ranges, although fasting study results and other time intervals met criteria

The EMA determined that this variation resulted from natural daily fluctuations in melatonin levels rather than formulation differences. The studies lacked sufficient subjects to account for individual variability in AUC measurements across different time intervals, as they were not originally designed to show bioequivalence for divided interval measurements.

The CHMP conducted the review after Germany referred the matter for arbitration in October 2025, determining that the totality of data, including additional measures of medicine absorption, adequately showed bioequivalence between Melatomed and its reference medicine. The European Commission will issue a decision valid throughout the EU in due course.

Detailed recommendations for product use will appear in the summary of product characteristics, which will be published on the EMA website following European Commission marketing authorization approval.

https://www.medscape.com/viewarticle/eu-clears-generic-sleep-aid-seniors-insomnia-2025a1000z5j