On-the-road driving performance the morning after bedtime use of suvorexant 15 and 30 mg in healthy elderly

Annemiek Vermeeren, Eva Vets, Eric F P M Vuurman, Anita C M Van Oers, Stefan Jongen, Tine Laethem, Ingeborg Heirman, An Bautmans, John Palcza, Xiadong Li, Matthew D Troyer, Rebecca Wrishko, Jacqueline McCrea, Hong Sun

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Abstract

Suvorexant is a first-in-class orexin receptor antagonist for treating insomnia. There is a general concern that hypnotics may impair next-morning driving ability.

The objective of this study was to evaluate next-morning driving performance in older adults after single and repeated doses of suvorexant.

Double-blind, randomized, placebo-controlled, 4-period crossover study in 24 healthy volunteers (10 females), aged 65-80 years. Subjects were treated with suvorexant (15 and 30 mg) for eight consecutive nights, zopiclone 7.5 mg nightly on days 1 and 8, and placebo. Driving performance was assessed on days 2 and 9 (9 h after dosing) using a 1-h standardized highway driving test in normal traffic, measuring standard deviation of lateral position (SDLP). Drug-placebo differences in SDLP > 2.4 cm were considered to reflect clinically meaningful driving impairment.

Driving performance as measured by SDLP was not impaired following suvorexant. Mean drug-placebo differences in SDLP following suvorexant 15 and 30 mg on day 2 and 9 were 0.6 cm or less. Their 90 % CIs were all below the threshold of 2.4 cm for clinical relevance and included zero, indicating effects were not clinically meaningful or statistically significant. Symmetry analysis showed no significant differences between the number of participants who had SDLP differences > 2.4 cm and those who had SDLP differences

There was no clinically meaningful residual effect of suvorexant 15 and 30 mg on next-morning driving (9 h after bedtime dosing) in healthy older adults, as assessed by mean changes in SDLP and by the number of participants on drug versus placebo that exceeded a predetermined threshold for clinically meaningful impairment.

Original languageEnglish
Pages (from-to)3341–3351
Number of pages11
JournalPsychopharmacology
Volume233
Issue number18
Early online date16 Jul 2016
DOIs
Publication statusPublished - Sep 2016

Keywords

  • Hypnotics
  • Suvorexant
  • Zopiclone
  • Orexin antagonist
  • Driving
  • Elderly
  • OREXIN RECEPTOR ANTAGONIST
  • ZOPICLONE 7.5 MG
  • PSYCHOMOTOR PERFORMANCE
  • PLACEBO
  • INSOMNIA
  • VOLUNTEERS
  • ALCOHOL
  • MEMORY
  • SLEEP
  • TRIAL

Cite this

Vermeeren, Annemiek ; Vets, Eva ; Vuurman, Eric F P M ; Van Oers, Anita C M ; Jongen, Stefan ; Laethem, Tine ; Heirman, Ingeborg ; Bautmans, An ; Palcza, John ; Li, Xiadong ; Troyer, Matthew D ; Wrishko, Rebecca ; McCrea, Jacqueline ; Sun, Hong. / On-the-road driving performance the morning after bedtime use of suvorexant 15 and 30 mg in healthy elderly. In: Psychopharmacology. 2016 ; Vol. 233, No. 18. pp. 3341–3351.
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abstract = "Suvorexant is a first-in-class orexin receptor antagonist for treating insomnia. There is a general concern that hypnotics may impair next-morning driving ability.The objective of this study was to evaluate next-morning driving performance in older adults after single and repeated doses of suvorexant.Double-blind, randomized, placebo-controlled, 4-period crossover study in 24 healthy volunteers (10 females), aged 65-80 years. Subjects were treated with suvorexant (15 and 30 mg) for eight consecutive nights, zopiclone 7.5 mg nightly on days 1 and 8, and placebo. Driving performance was assessed on days 2 and 9 (9 h after dosing) using a 1-h standardized highway driving test in normal traffic, measuring standard deviation of lateral position (SDLP). Drug-placebo differences in SDLP > 2.4 cm were considered to reflect clinically meaningful driving impairment.Driving performance as measured by SDLP was not impaired following suvorexant. Mean drug-placebo differences in SDLP following suvorexant 15 and 30 mg on day 2 and 9 were 0.6 cm or less. Their 90 {\%} CIs were all below the threshold of 2.4 cm for clinical relevance and included zero, indicating effects were not clinically meaningful or statistically significant. Symmetry analysis showed no significant differences between the number of participants who had SDLP differences > 2.4 cm and those who had SDLP differencesThere was no clinically meaningful residual effect of suvorexant 15 and 30 mg on next-morning driving (9 h after bedtime dosing) in healthy older adults, as assessed by mean changes in SDLP and by the number of participants on drug versus placebo that exceeded a predetermined threshold for clinically meaningful impairment.",
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author = "Annemiek Vermeeren and Eva Vets and Vuurman, {Eric F P M} and {Van Oers}, {Anita C M} and Stefan Jongen and Tine Laethem and Ingeborg Heirman and An Bautmans and John Palcza and Xiadong Li and Troyer, {Matthew D} and Rebecca Wrishko and Jacqueline McCrea and Hong Sun",
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Vermeeren, A, Vets, E, Vuurman, EFPM, Van Oers, ACM, Jongen, S, Laethem, T, Heirman, I, Bautmans, A, Palcza, J, Li, X, Troyer, MD, Wrishko, R, McCrea, J & Sun, H 2016, 'On-the-road driving performance the morning after bedtime use of suvorexant 15 and 30 mg in healthy elderly', Psychopharmacology, vol. 233, no. 18, pp. 3341–3351. https://doi.org/10.1007/s00213-016-4375-x

On-the-road driving performance the morning after bedtime use of suvorexant 15 and 30 mg in healthy elderly. / Vermeeren, Annemiek; Vets, Eva; Vuurman, Eric F P M; Van Oers, Anita C M; Jongen, Stefan; Laethem, Tine; Heirman, Ingeborg; Bautmans, An; Palcza, John; Li, Xiadong; Troyer, Matthew D; Wrishko, Rebecca; McCrea, Jacqueline; Sun, Hong.

In: Psychopharmacology, Vol. 233, No. 18, 09.2016, p. 3341–3351.

Research output: Contribution to journalArticleAcademicpeer-review

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T1 - On-the-road driving performance the morning after bedtime use of suvorexant 15 and 30 mg in healthy elderly

AU - Vermeeren, Annemiek

AU - Vets, Eva

AU - Vuurman, Eric F P M

AU - Van Oers, Anita C M

AU - Jongen, Stefan

AU - Laethem, Tine

AU - Heirman, Ingeborg

AU - Bautmans, An

AU - Palcza, John

AU - Li, Xiadong

AU - Troyer, Matthew D

AU - Wrishko, Rebecca

AU - McCrea, Jacqueline

AU - Sun, Hong

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KW - ZOPICLONE 7.5 MG

KW - PSYCHOMOTOR PERFORMANCE

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KW - VOLUNTEERS

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KW - SLEEP

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