Next-Day Effects of Ramelteon (8 mg), Zopiclone (7.5 mg), and Placebo on Highway Driving Performance, Memory Functioning, Psychomotor Performance, and Mood in Healthy Adult Subjects

• DOI: 10.5665/sleep.1272
• Publication Date: 2011-09-30T17:19:55Z
• Authors: Monique A.J. Mets; Juna M. de Vries; Lieke M. de Sener...; Edmund R. Volkerts; Berend Olivier; Joris C. Verster
• Keywords: Zopiclone; Crossover study

To evaluate the next-morning residual effects of ramelteon (8 mg), zopiclone (7.5 and placebo on driving performance, memory functioning, psychomotor mood in healthy adult subjects following bedtime dosing a middle night awakening.Single-center, randomized, double-blind, double-dummy, placebo-controlled, crossover study.Utrecht University, The Netherlands.30 volunteers (15 males 15 females).a single dose placebo, administered at bedtime.A balance test was performed night. Other tests were morning, 8.5 h after administration. Subjects 100-km highway normal traffic. Primary outcome measure standard deviation lateral position (SDLP), i.e., weaving car. After driving, cognitive, memory, assessed.SDLP significantly increased intake (+2.2 cm) (+2.9 cm). Ramelteon produced significant impairment reaction time (P<0.024) Sternberg Memory Scanning Test, slow (P<0.007) fast (P<0.010) tracking, speed (P<0.015) tracking (P<0.001) Divided Attention delayed recall (P<0.032) Word Learning Test. In contrast to ramelteon, additionally impaired performance Digit Symbol Substitution Test (P<0.001).Ramelteon mg) morning zopiclone, no impairments. CLINICAL TRIAL IDENTIFIER: NCT00319215 (www.clinicaltrials.gov).