New data for suvorexant (Merck Inc.) for treatment of Insomnia

Merck Inc., announced new data for suvorexant, the investigational medicine for the treatment of Insomnia. The new data are from one of the longest, continuously-dosed, placebo-controlled trials of a sleep medication ever conducted. This 12-month study was designed to assess the safety of suvorexant, while also evaluating its longer term efficacy. Merck presented new results from a two-month discontinuation phase that followed the 12-month study at the 21st Congress of the European Sleep Research Society (ESRS).

Researchers found that the patients who had been taking suvorexant for 12 months and were switched to placebo saw their insomnia return, but clinically meaningful withdrawal symptoms and rebound insomnia did not emerge. Specifically, results from the two-month discontinuation phase showed that, after daily use of a consistent dose of suvorexant for one year, patients who stopped taking the medicine experienced a return of their sleeping difficulties to levels similar to those reported by patients who received placebo over the course of the trial. Patients who continued to receive suvorexant for the additional two months experienced mean improvements in their ability to fall asleep and stay asleep that were consistent with those seen over the first 12 months compared to placebo.

Merck plans to file an NDA at the FDA in 2012.If approved, suvorexant would be the first in a new class of medicines, called orexin receptor antagonists, for use in patients with difficulty falling or staying asleep.