Neurim Pharmaceuticals has confirmed that Circadin has gained approval for treatment of primary insomnia in patients aged 55 and over. The European Commission has approved a change in treatment from 3 to 13 weeks (or 3 months).
The approval was based primarily on data obtained in the latest SOUNDER-SLEEP Phase IV clinical study, indicating that Circadin was safe and more effective than placebo for at least 3 months. Circadin is now the only sleep medication to be approved for up to 3 months.
