On-the-Road Driving Performance the Morning after Bedtime Use of Suvorexant 20 and 40 mg: A Study in Non-Elderly Healthy Volunteers

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

Research output: Contribution to journalArticleAcademicpeer-review

6 Citations (Scopus)

Abstract

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. 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. 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 cm 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 female subjects requested that a total of 5 driving tests-all following suvorexant-stop prematurely due to self-reported somnolence. Conclusions: As assessed by mean changes in standard deviation of lateral position (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.
Original languageEnglish
Pages (from-to)1803-1813
Number of pages12
JournalSleep
Volume38
Issue number11
DOIs
Publication statusPublished - 1 Nov 2015

Keywords

  • Adult
  • Automobile Driving
  • Azabicyclo Compounds
  • Azepines
  • Cross-Over Studies
  • Double-Blind Method
  • Female
  • Healthy Volunteers
  • Humans
  • Individuality
  • Male
  • Middle Aged
  • Netherlands
  • Piperazines
  • Psychomotor Performance
  • Self Report
  • Sleep Aids, Pharmaceutical
  • Sleep Stages
  • Triazoles
  • Young Adult
  • SLEEP
  • memory
  • INSOMNIA PATIENTS
  • suvorexant
  • IMPAIRMENT
  • DSST
  • HYPNOTICS
  • ZOLPIDEM
  • balance
  • ALCOHOL
  • MEMORY
  • hypnotics
  • PLACEBO
  • zopiclone
  • ZOPICLONE 7.5 MG
  • plasma concentrations
  • driving
  • OREXIN RECEPTOR ANTAGONIST
  • orexin antagonist

Cite this

Vermeeren, Annemiek ; Sun, Hong ; Vuurman, Eric F P M ; Jongen, Stefan ; Van Leeuwen, Cees J ; Van Oers, Anita C M ; Palcza, John ; Li, Xiadong ; Laethem, Tine ; Heirman, Ingeborg ; Bautmans, An ; Troyer, Matthew D ; Wrishko, Rebecca ; McCrea, Jacqueline. / On-the-Road Driving Performance the Morning after Bedtime Use of Suvorexant 20 and 40 mg : A Study in Non-Elderly Healthy Volunteers. In: Sleep. 2015 ; Vol. 38, No. 11. pp. 1803-1813.
@article{b4ef627742be40ab9cfabf74d3c6a56d,
title = "On-the-Road Driving Performance the Morning after Bedtime Use of Suvorexant 20 and 40 mg: A Study in Non-Elderly Healthy Volunteers",
abstract = "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. 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. 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 cm 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 female subjects requested that a total of 5 driving tests-all following suvorexant-stop prematurely due to self-reported somnolence. Conclusions: As assessed by mean changes in standard deviation of lateral position (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.",
keywords = "Adult, Automobile Driving, Azabicyclo Compounds, Azepines, Cross-Over Studies, Double-Blind Method, Female, Healthy Volunteers, Humans, Individuality, Male, Middle Aged, Netherlands, Piperazines, Psychomotor Performance, Self Report, Sleep Aids, Pharmaceutical, Sleep Stages, Triazoles, Young Adult, SLEEP, memory, INSOMNIA PATIENTS, suvorexant, IMPAIRMENT, DSST, HYPNOTICS, ZOLPIDEM, balance, ALCOHOL, MEMORY, hypnotics, PLACEBO, zopiclone, ZOPICLONE 7.5 MG, plasma concentrations, driving, OREXIN RECEPTOR ANTAGONIST, orexin antagonist",
author = "Annemiek Vermeeren and Hong Sun and Vuurman, {Eric F P M} and Stefan Jongen and {Van Leeuwen}, {Cees J} and {Van Oers}, {Anita C M} and John Palcza and Xiadong Li and Tine Laethem and Ingeborg Heirman and An Bautmans and Troyer, {Matthew D} and Rebecca Wrishko and Jacqueline McCrea",
note = "{\circledC} 2015 Associated Professional Sleep Societies, LLC.",
year = "2015",
month = "11",
day = "1",
doi = "10.5665/sleep.5168",
language = "English",
volume = "38",
pages = "1803--1813",
journal = "Sleep",
issn = "0161-8105",
publisher = "American Academy of Sleep Medicine",
number = "11",

}

Vermeeren, A, Sun, H, Vuurman, EFPM, Jongen, S, Van Leeuwen, CJ, Van Oers, ACM, Palcza, J, Li, X, Laethem, T, Heirman, I, Bautmans, A, Troyer, MD, Wrishko, R & McCrea, J 2015, 'On-the-Road Driving Performance the Morning after Bedtime Use of Suvorexant 20 and 40 mg: A Study in Non-Elderly Healthy Volunteers', Sleep, vol. 38, no. 11, pp. 1803-1813. https://doi.org/10.5665/sleep.5168

On-the-Road Driving Performance the Morning after Bedtime Use of Suvorexant 20 and 40 mg : A Study in Non-Elderly Healthy Volunteers. / Vermeeren, Annemiek; Sun, Hong; Vuurman, Eric F P M; Jongen, Stefan; Van Leeuwen, Cees J; Van Oers, Anita C M; Palcza, John; Li, Xiadong; Laethem, Tine; Heirman, Ingeborg; Bautmans, An; Troyer, Matthew D; Wrishko, Rebecca; McCrea, Jacqueline.

In: Sleep, Vol. 38, No. 11, 01.11.2015, p. 1803-1813.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - On-the-Road Driving Performance the Morning after Bedtime Use of Suvorexant 20 and 40 mg

T2 - A Study in Non-Elderly Healthy Volunteers

AU - Vermeeren, Annemiek

AU - Sun, Hong

AU - Vuurman, Eric F P M

AU - Jongen, Stefan

AU - Van Leeuwen, Cees J

AU - Van Oers, Anita C M

AU - Palcza, John

AU - Li, Xiadong

AU - Laethem, Tine

AU - Heirman, Ingeborg

AU - Bautmans, An

AU - Troyer, Matthew D

AU - Wrishko, Rebecca

AU - McCrea, Jacqueline

N1 - © 2015 Associated Professional Sleep Societies, LLC.

PY - 2015/11/1

Y1 - 2015/11/1

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. 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. 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 cm 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 female subjects requested that a total of 5 driving tests-all following suvorexant-stop prematurely due to self-reported somnolence. Conclusions: As assessed by mean changes in standard deviation of lateral position (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.

AB - 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. 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. 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 cm 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 female subjects requested that a total of 5 driving tests-all following suvorexant-stop prematurely due to self-reported somnolence. Conclusions: As assessed by mean changes in standard deviation of lateral position (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.

KW - Adult

KW - Automobile Driving

KW - Azabicyclo Compounds

KW - Azepines

KW - Cross-Over Studies

KW - Double-Blind Method

KW - Female

KW - Healthy Volunteers

KW - Humans

KW - Individuality

KW - Male

KW - Middle Aged

KW - Netherlands

KW - Piperazines

KW - Psychomotor Performance

KW - Self Report

KW - Sleep Aids, Pharmaceutical

KW - Sleep Stages

KW - Triazoles

KW - Young Adult

KW - SLEEP

KW - memory

KW - INSOMNIA PATIENTS

KW - suvorexant

KW - IMPAIRMENT

KW - DSST

KW - HYPNOTICS

KW - ZOLPIDEM

KW - balance

KW - ALCOHOL

KW - MEMORY

KW - hypnotics

KW - PLACEBO

KW - zopiclone

KW - ZOPICLONE 7.5 MG

KW - plasma concentrations

KW - driving

KW - OREXIN RECEPTOR ANTAGONIST

KW - orexin antagonist

U2 - 10.5665/sleep.5168

DO - 10.5665/sleep.5168

M3 - Article

C2 - 26039969

VL - 38

SP - 1803

EP - 1813

JO - Sleep

JF - Sleep

SN - 0161-8105

IS - 11

ER -