Neurim Pharmaceuticals announces clinical approval for insomnia medication in elderly patients

SEATTLE Neurim Pharmaceuticals announced that Circadin in 2-mg strength showed long-term efficacy and safety in elderly patients during a large-scale phase three study.

Circadin is a well-known prolonged-release melatonin used to treat primary insomnia, described by poor quality in sleep in patients over 55 years. The drug was approved by the European Commission pharmaceutical regulatory agency and the Israeli Ministry of Health for short-term treatment after clinical studies showed improvement in patient’s sleep quality, sleep induction and next day alertness and functioning.

The study based on more than 790 insomnia patients ages 18 to 80 showed six months of continuous treatment with Circadin is both safe and efficacious.

The results were announced in the Late Breaking Abstracts session of SLEEP 2009, the 23rd Annual Meeting of the Associated Professional Sleep Societies in Seattle, Wash.