It is known that psychoactive drugs may produce impairment of attentio
n and skills involved in driving performance and thus may increase the
risk of traffic accident involvement. Several reliable and sensitive
methods are available to assess different aspects of driving performan
ce in safe conditions. They include various laboratory tests which exp
lore psychomotor performance and cognitive functions (selective and di
vided attention, speed of reaction, sustained attention), electrophysi
ological measures (spectral analysis of resting EEG, multiple sleep la
tency test, saccadic eye movement) and other more complex measures suc
h as driving simulators and on-the-road actual driving tests. Various
combinations of these techniques should be used to demonstrate potenti
al drug-induced changes in driving or skills related to driving in sta
ndardized placebo-controlled studies with healthy volunteers and/or pa
tients. In my opinion, in addition to efficacy, behavioural toxicity s
hould be assessed during drug development in order to obtain a reliabl
e evaluation of the benefit/risk ratio for the patients and should be
included in the registration file of all new psychoactive drugs. (C) 1
998 John Wiley & Sons, Ltd.