title: Lapses of attention as outcome measure of the on-the-road driving test.
abstract: 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: Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacology, Utrecht University, Universiteitsweg 99, 3584 CG, Utrecht, The Netherlands, j.c.verster@uu.nl.
authors: Joris C
authors: JC
authors: Verster
authors: Adriana C
authors: AC
authors: Bervoets
authors: Suzanne
authors: S
authors: de Klerk
authors: Thomas
authors: T
authors: Roth
mesh_terms: D000081:Acetamides / Q000494:pharmacology; D000328:Adult; D001288:Attention / Q000187:drug effects / Q000502:physiology*; D001333:Automobile Driver Examination / Q000523:psychology*; D001334:Automobile Driving / Q000523:psychology*; D053961:Azabicyclo Compounds / Q000494:pharmacology; D003627:Data Interpretation, Statistical; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000494:pharmacology; D007192:Indenes / Q000494:pharmacology; D008297:Male; D010879:Piperazines / Q000494:pharmacology; D011725:Pyridines / Q000494:pharmacology; D011743:Pyrimidines / Q000494:pharmacology; D012727:Sex Characteristics; D000077334:Zolpidem
chemical_list: D000081:Acetamides; D053961:Azabicyclo Compounds; D006993:Hypnotics and Sedatives; D007192:Indenes; D010879:Piperazines; D011725:Pyridines; D011743:Pyrimidines; C515050:zopiclone; D000077334:Zolpidem; C495910:ramelteon; C085665:zaleplon
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