Highway Driving Performance and Cognitive Functioning the Morning after Bedtime and Middle-of-the-Night Use of Gaboxadol, Zopiclone and Zolpidem

This article reports on a study that assessed the residual effects of evening and middle-of-the-night administration of 15 mg of gaboxadol on cognitive, psychomotor and driving performance. Gaboxadol is a selective extrasynaptic GABAA receptor agonist, in development for the treatment of insomnia. Due to its short half-life (1.5–2 h) it is expected to be free from residual effects the next morning. The double-blind, placebo-controlled, active-referenced five-way cross-over study included 28 healthy volunteers, of whom 25 completed the full study (12 women; mean age 31.4 years). Each treatment night subjects ingested one capsule at 23:00 hours and one at 04:00 hours. Treatments were: placebo at both times, 15 mg gaboxadol or 7.5 mg zopiclone followed by placebo, and placebo followed by 15 mg gaboxadol or 10 mg zolpidem. The participants underwent assessment of cognition and psychomotor performance between 07:30 and 08:30 hours and of driving between 09:00 and 10:00 hours. The study found that driving, as measured by standard deviation of lateral position in an on-the-road driving test, nearly reached significance (P < 0.07) for impairment after evening administration of gaboxadol for the all-subjects-completed set (n = 25) and did reach significance (P < 0.05) in the full analysis set (n = 28). Evening administration of gaboxadol had minor effects on divided attention only, whereas middle-of-the-night administration impaired performance significantly in all tests except memory. Zolpidem and zopiclone impaired performance significantly in every test except tracking after zopiclone. The authors conclude that 15 mg of gaboxadol can produce minor residual effects on driving between 10 and 11 hours after evening administration. Results also confirm the importance of instructing patients to ingest 10 mg zolpidem only prior to a full 8 hours of uninterrupted sleep. In addition, 7.5 mg of zopiclone taken at bedtime consistently impairs driving the next morning at least until 11 hours after intake, although subjects seem unaware of this effect. The authors reiterate the importance of warning patients about the residual effects of hypnotics.

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  • Authors:
    • Leufkens, Tim R M
    • Lund, Jesper S
    • Vermeeren, Annemiek
  • Publication Date: 2009-12


  • English

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  • Accession Number: 01148167
  • Record Type: Publication
  • Files: TRIS
  • Created Date: Dec 31 2009 10:03AM