TY  - JOUR
PY  - 2015//
TI  - On-the-road driving performance the morning after bedtime use of suvorexant 20 and 40 mg: a study in non-elderly healthy volunteers
JO  - Sleep
A1  - Vermeeren, Annemiek
A1  - Sun, Hong
A1  - Vuurman, Eric F. P. M.
A1  - Jongen, Stefan
A1  - Van Leeuwen, Cees J.
A1  - Van Oers, Anita C. M.
A1  - Palcza, John
A1  - Li, Xiadong
A1  - Laethem, Tine
A1  - Heirman, Ingeborg
A1  - Bautmans, An
A1  - Troyer, Matthew D.
A1  - Wrishko, Rebecca
A1  - McCrea, Jacqueline
SP  - 1803
EP  - 1813
VL  - 38
IS  - 11
N2  - STUDY OBJECTIVE: To evaluate next-morning driving performance in adults younger than 65 years, after single and repeated doses of suvorexant 20 and 40 mg. <br><br>DESIGN: Double-blind, placebo-controlled, 4-period crossover study. SETTING: Maastricht University, The Netherlands. PARTICIPANTS: 28 healthy volunteers (15 females), aged 23 to 64 years. INTERVENTIONS: Suvorexant (20 and 40 mg) for 8 consecutive nights; zopiclone 7.5 mg nightly on day 1 and 8; placebo. MEASUREMENTS: Performance on day 2 and 9 (9 h after dosing) using a one-hour standardized highway driving test in normal traffic, measuring Standard Deviation of Lateral Position (SDLP). Drug-placebo changes in SDLP >2.4 cm were considered to reflect meaningful driving impairment. <br><br>RESULTS: Mean drug-placebo changes in SDLP following suvorexant 20 and 40 mg were 1.01 and 1.66 cm on day 2, and 0.48 and 1.31 on Day 9, respectively. The 90% CIs of these changes were all below 2.4 cm. Symmetry analysis showed that more subjects had SDLP changes >2.4 cm than <-2.4 cm following suvorexant 20 and 40 mg on day 2, and following suvorexant 40 mg on day 9. Four subjects requested that a total of 5 driving tests-all following suvorexant-stop prematurely due to self-reported somnolence. <br><br>CONCLUSIONS: As assessed by mean changes in SDLP, there was no clinically meaningful residual effect of suvorexant in doses of 20 and 40 mg on next-morning driving (9 h after bedtime dosing) in healthy subjects <65 years old. There may be some individuals who experience next-day effects, as suggested by individual changes in SDLP and prematurely stopped tests. (Clinical Trial Information: clinicaltrials.gov NCT01311882).<p />  <p>Language: en</p>
LA  - en
SN  - 0161-8105
UR  - http://dx.doi.org/
ID  - ref1
ER  -