Mid-stage trial results positive for Merck's insomnia drug
SAN ANTONIO An investigational treatment made by Merck for insomnia was more effective than placebo in improving patients’ sleep at night, according to results of a mid-stage clinical trial.
The phase 2b trial data, presented earlier this month at SLEEP 2010, the 24th annual meeting of the Associated Professional Sleep Societies, indicated that Merck’s MK-4305 improved sleep efficiency, measured by the total amount of sleep time divided by eight hours of time in bed compared with placebo. A total of 243 patients received MK-4305 in doses of 10 mg, 20 mg, 40 mg or 80 mg, while 249 received placebo.
Insomnia affects about 10% of the general population and involves such problems as difficulty falling asleep, staying asleep and returning to sleep. Merck said it plans to file for regulatory approval for the drug in 2012.