Evaluation of the residual effects of brotizolam on cognitive performance in subjects with circadian rhythm disorders (shift workers) was the aim of this double-blind crossover study. Thirteen shift workers (mean age, 27.9 years), who reported episodes of daytime insomnia, entered the final evaluation; three other subjects were withdrawn due to lack of compliance. During the two 15-day treatment periods, each subject received brotizolam 0.25 mg/day and placebo immediately before going to bed for the night or before their longest period of sleep during the day after the night shift. The two treatments were separated by a 15-day washout period. A battery of six neuropsychological tests (ie, Rey's test for verbal memory, auditory attention test, visual attention test, simple reaction test, test of lateralized letter reading, the test of lateralized visual pattern detection), performed at baseline and repeated after acute (day 1) and chronic (day 15) administration, demonstrated that with brotizolam the subjects did not develop residual effects that would significantly impair their performance, either compared with the baseline values or with placebo. The study results indicate that brotizolam may be considered to be a safe compound in the treatment of insomnia in patients with circadian rhythm disorders.
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