"Some medications taken for sleep are associated with lingering effects the next day, which could make performing activities requiring mental sharpness difficult or dangerous," said Gary Zammit, PhD, Director, Sleep Disorders Institute at St. Luke's-Roosevelt Hospital, New York. "These data suggest that ROZEREM can promote sleep in patients with transient insomnia without evidence of next-day psychomotor or memory effects."
A total of 289 healthy adults were randomized to receive either ROZEREM 8 mg, 16 mg, or placebo 30 minutes before bedtime in this double-blind, parallel-group study designed to evaluate the efficacy of ROZEREM in a first-night-effect model of transient insomnia. Sleep was assessed with overnight polysomnography (PSG) a test that records brain activity and other body functions during sleep and a patient questionnaire completed the following morning. Patients also completed next-morning residual-effect assessments evaluating potential residual psychomotor or memory impairment.
Results found that ROZEREM was not associated with next-morning residual effects, as measured by Digit Symbol Substitution Test, memory tests for immediate and delayed recall, and visual analog scales that rate patient reports of mood and feeling. Adverse event rates were 12.4 percent, 13.3 percent, and 6.4 percent for the placebo, ROZEREM 8 mg, and ROZEREM 16 mg groups, respectively, with no clinically meaningful changes in laboratory value, vital sign, or electrocardiogram results observed.
Contact: Jocelyn M. Gerst