BACKGROUND: Lapses are brief periods of inattention and reduced alertness which may be a risk factor for car crashes. The Dutch on-the-road driving test is applied to examine effects of CNS drugs on driving, using the standard deviation of lateral position (SDLP) as primary outcome measure. This paper examines the utility of an alternative outcome measure, lapses, to determine the degree to which CNS drugs impair driving. METHODS: Data from two double-blind, placebo-controlled on-the-road driving studies that examined the residual effects of hypnotic drugs were reanalyzed. The treatments were zaleplon and zolpidem tested 4 h after middle-of-the-night administration, and ramelteon and zopiclone tested 8.5 h after bedtime administration. In addition to SDLP, outcome measures related to lapses (number, total duration, and maximum deviation) were computed. A lapse was defined as a continuous change in lateral position of greater than 100 cm, lasting for at least 4 s. RESULTS: Both SDLP and lapses were able to detect significant driving impairment after middle-of-the-night administration of zolpidem (10 and 20 mg) and bedtime administration of ramelteon (8 mg) and zopiclone (7.5 mg) relative to placebo. Both measures found no differences from placebo after middle-of-the-night administration of zaleplon (10 and 20 mg). The number of lapses was more sensitive in differentiating treatment from placebo than the maximum deviation of a lapse or their duration. After considering different lapse duration criteria, a lapse was redefined as a continuous change in lateral position of greater than 100 cm, lasting for at least 8 s. This change in definition did not significantly alter the outcome of the statistical analyses. CONCLUSIONS: In addition to SDLP, the number of lapses is a useful outcome measure to identify treatments that impair driving. Future research should determine the unique contributions of SDLP and lapses in defining the potential risk of CNS drugs on driving.
RCT Entities:
BACKGROUND: Lapses are brief periods of inattention and reduced alertness which may be a risk factor for car crashes. The Dutch on-the-road driving test is applied to examine effects of CNS drugs on driving, using the standard deviation of lateral position (SDLP) as primary outcome measure. This paper examines the utility of an alternative outcome measure, lapses, to determine the degree to which CNS drugs impair driving. METHODS: Data from two double-blind, placebo-controlled on-the-road driving studies that examined the residual effects of hypnotic drugs were reanalyzed. The treatments were zaleplon and zolpidem tested 4 h after middle-of-the-night administration, and ramelteon and zopiclone tested 8.5 h after bedtime administration. In addition to SDLP, outcome measures related to lapses (number, total duration, and maximum deviation) were computed. A lapse was defined as a continuous change in lateral position of greater than 100 cm, lasting for at least 4 s. RESULTS: Both SDLP and lapses were able to detect significant driving impairment after middle-of-the-night administration of zolpidem (10 and 20 mg) and bedtime administration of ramelteon (8 mg) and zopiclone (7.5 mg) relative to placebo. Both measures found no differences from placebo after middle-of-the-night administration of zaleplon (10 and 20 mg). The number of lapses was more sensitive in differentiating treatment from placebo than the maximum deviation of a lapse or their duration. After considering different lapse duration criteria, a lapse was redefined as a continuous change in lateral position of greater than 100 cm, lasting for at least 8 s. This change in definition did not significantly alter the outcome of the statistical analyses. CONCLUSIONS: In addition to SDLP, the number of lapses is a useful outcome measure to identify treatments that impair driving. Future research should determine the unique contributions of SDLP and lapses in defining the potential risk of CNS drugs on driving.
Authors: Joris C Verster; Edmund R Volkerts; Antonia H C M L Schreuder; Erik J E Eijken; Janet H G van Heuckelum; Dieuwke S Veldhuijzen; Marinus N Verbaten; Isabelle Paty; Mona Darwish; Philippe Danjou; Alain Patat Journal: J Clin Psychopharmacol Date: 2002-12 Impact factor: 3.153
Authors: Joris C Verster; Adriana C Bervoets; Suzanne de Klerk; Rick A Vreman; Berend Olivier; Thomas Roth; Karel A Brookhuis Journal: Psychopharmacology (Berl) Date: 2014-02-22 Impact factor: 4.530
Authors: Joris C Verster; Chris Alford; Adriana C Bervoets; Suzanne de Klerk; James A Grange; Anna Hogewoning; Kate Jones; Darren L Kruisselbrink; Lauren Owen; Thomas M Piasecki; Senta Jorinde Raasveld; Sam Royle; Wendy S Slutske; Gordon S Smith; Richard Stephens Journal: Curr Drug Abuse Rev Date: 2013-09
Authors: Annemiek Vermeeren; Stefan Jongen; Patricia Murphy; Margaret Moline; Gleb Filippov; Kate Pinner; Carlos Perdomo; Ishani Landry; Oneeb Majid; Anita C M Van Oers; Cees J Van Leeuwen; Johannes G Ramaekers; Eric F P M Vuurman Journal: Sleep Date: 2019-04-01 Impact factor: 5.849
Authors: F R J Vinckenbosch; A Vermeeren; J C Verster; J G Ramaekers; E F Vuurman Journal: Psychopharmacology (Berl) Date: 2020-01-03 Impact factor: 4.530