Vanda says study shows sleep aid med did not impair driving performance

Vanda Pharmaceuticals announced the results of a HETLIOZ driving study to measure next day performance. Tasimelteon did not impair measures of driving performance, whereas the active control, zopiclone, showed significant impairment. In this triple crossover study, 48 healthy volunteers drove 100 km in a validated driving simulator the morning after taking a bedtime dose of either tasimelteon 20 mg, zopiclone 7.5 mg or placebo. The volunteers were instructed to operate the driving simulator for approximately 1 hour with a speed of 55 mph while maintaining lane position. Treatment with tasimelteon 20 mg at bedtime demonstrated no next day driving impairment compared to placebo. Treatment with zopiclone 7.5 mg dosed at bedtime was associated with a meaningful and significant increase in Standard Deviation of Lateral Position, a measure of lane weaving, compared to the placebo treatment. A secondary analysis of the paired differences between treatments confirmed that tasimelteon did not impair next day driving while there was an impairment with zopiclone. A difference of 4.4 cm is considered equivalent to the driving impairment associated with a blood alcohol level of 0.05%, a level associated with increased crash risk. “Compared to other sleep agents where we’ve investigated next-day residual effects on driving, tasimelteon demonstrated no impairment when evaluated 9 hours after dosing,” said Gary G. Kay, Ph.D., President of Cognitive Research Corporation, the contract research organization who ran the study.
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