Insomnia Drug Shows Promising Results

Pharmacy Times, Volume 0, 0

A phase 3 trial of doxepin HCl(SILENOR) in doses of 3 mg and 6 mgyielded positive results in the treatmentof insomnia. Researchers measuredsleep using the 8-hour Wake After SleepOnset (WASO), which uses polysomnographyin a sleep laboratory. Mean WASOimproved by 26 minutes with the 3-mgdose and by 31 minutes with the 6-mgdose, compared with placebo. Total sleeptime was 374 minutes for placebo, 415minutes for the 3-mg dose, and 421 minutesfor the 6-mg dose. At 4 weeks,results had lasted significantly longer forSILENOR, compared with placebo. Sleepefficiency also was statistically significantlyhigher for the SILENOR groups,compared with placebo. Another importantsleep measure, Latency toPersistent Sleep, showed significantlyimproved outcomes—45 minutes forplacebo and 27 minutes for bothSILENOR groups. SILENOR was well-tolerated,and side effects were comparableto those with placebo. Rebound insomnia,withdrawal effects, memory impairment,weight gain, and anticholinergiceffects were not observed.

Ms. Farley is a freelance medicalwriter based in Wakefield, RI.