STUDY OBJECTIVES: To compare residual effects of zaleplon 10 mg, zopiclone 7.5 mg, and placebo, and a social dose of alcohol on car driving, memory, and psychomotor performance. DESIGN: Two-part placebo controlled, crossover study. Part 1 was single blind, Part 2 double blind. SETTING: University research institute. PARTICIPANTS: Thirty healthy volunteers (15 men and 15 women, mean age 32 +/- 7 years) INTERVENTIONS: In Part 1 alcohol and alcohol-placebo drinks were administered around noon. In Part 2 single oral doses of zaleplon 10 mg, zopiclone 7.5 mg and placebo were administered at bedtime. MEASUREMENT AND RESULTS: A highway driving test, laboratory tests of word learning, critical tracking and divided attention, and subjective assessments of sleep, mood, and effects of treatments on driving. Driving started 40 minutes after a second alcohol dose in Part 1, and 10 hours after drug intake in Part 2. The results demonstrated that alcohol, at average plasma concentrations of approximately 0.030 g/dl, significantly impaired performance in all tests. Zaleplon's residual effects did not differ significantly from those of placebo in any test. In contrast, zopiclone had significant residual effects on driving, divided attention, and memory. The magnitude of impairment in the driving test observed the morning after zopiclone 7.5 mg was twice that observed with alcohol. CONCLUSION:Zaleplon 10 mg has no residual effects on driving when taken at bedtime, 10 hours before driving. In contrast, zopiclone 7.5 mg can cause marked residual impairment. Patients should be advised to avoid driving the morning after zopiclone administration.
RCT Entities:
STUDY OBJECTIVES: To compare residual effects of zaleplon 10 mg, zopiclone 7.5 mg, and placebo, and a social dose of alcohol on car driving, memory, and psychomotor performance. DESIGN: Two-part placebo controlled, crossover study. Part 1 was single blind, Part 2 double blind. SETTING: University research institute. PARTICIPANTS: Thirty healthy volunteers (15 men and 15 women, mean age 32 +/- 7 years) INTERVENTIONS: In Part 1 alcohol and alcohol-placebo drinks were administered around noon. In Part 2 single oral doses of zaleplon 10 mg, zopiclone 7.5 mg and placebo were administered at bedtime. MEASUREMENT AND RESULTS: A highway driving test, laboratory tests of word learning, critical tracking and divided attention, and subjective assessments of sleep, mood, and effects of treatments on driving. Driving started 40 minutes after a second alcohol dose in Part 1, and 10 hours after drug intake in Part 2. The results demonstrated that alcohol, at average plasma concentrations of approximately 0.030 g/dl, significantly impaired performance in all tests. Zaleplon's residual effects did not differ significantly from those of placebo in any test. In contrast, zopiclone had significant residual effects on driving, divided attention, and memory. The magnitude of impairment in the driving test observed the morning after zopiclone 7.5 mg was twice that observed with alcohol. CONCLUSION:Zaleplon 10 mg has no residual effects on driving when taken at bedtime, 10 hours before driving. In contrast, zopiclone 7.5 mg can cause marked residual impairment. Patients should be advised to avoid driving the morning after zopiclone administration.
Authors: Arthur A Simen; Cynthia Gargano; Jang-Ho Cha; Melissa Drexel; An Bautmans; Ingeborg Heirman; Tine Laethem; Thomas Hochadel; Lien Gheyle; Kim Bleys; Chan Beals; Aubrey Stoch; Gary G Kay; Arie Struyk Journal: Ther Adv Drug Saf Date: 2015-06
Authors: Markus B Schumacher; Stefan Jongen; Anja Knoche; Frank Petzke; Eric F Vuurman; Mark Vollrath; Johannes G Ramaekers Journal: Psychopharmacology (Berl) Date: 2017-02-12 Impact factor: 4.530
Authors: Annemiek Vermeeren; Hong Sun; Eric F P M Vuurman; Stefan Jongen; Cees J Van Leeuwen; Anita C M Van Oers; John Palcza; Xiadong Li; Tine Laethem; Ingeborg Heirman; An Bautmans; Matthew D Troyer; Rebecca Wrishko; Jacqueline McCrea Journal: Sleep Date: 2015-11-01 Impact factor: 5.849
Authors: Tim R M Leufkens; Annemiek Vermeeren; Beitske E Smink; Peter van Ruitenbeek; Johannes G Ramaekers Journal: Psychopharmacology (Berl) Date: 2007-01-12 Impact factor: 4.530
Authors: Annemiek Vermeeren; Eric F P M Vuurman; Tim R M Leufkens; Cees J Van Leeuwen; Anita C M Van Oers; Eugene Laska; Salvador Rico; Frank Steinberg; Thomas Roth Journal: Sleep Date: 2014-03-01 Impact factor: 5.849
Authors: Carlos A Vaz Fragoso; Katy L B Araujo; Peter H Van Ness; Richard A Marottoli Journal: J Gerontol A Biol Sci Med Sci Date: 2008-07 Impact factor: 6.053