DAYVIGO showed no statistically significant difference to placebo on driving performance for any dose on Days 2 & 9. Additionally, No Lapses (i.e. deviation of at least 100 cm for at least 8 seconds during a driving test on a 100 km motorway) were detected during the on-road driving tests on Days 2 & 9 in subjects on any dose of Dayvigo and placebo treatment periods.
The validity of the study is supported by the results from administration of active control (zopiclone 7.5 mg), which demonstrated driving impairment on both Days 2 & 9. However, driving ability was impaired in some subjects taking 10 mg Dayvigo and such patients should be cautioned about next-day driving impairment.
The effect of Dayvigo on next-day postural stability compared to placebo was evaluated in 2 randomized, placebo-controlled clinical studies. DAYVIGO had no significant effects on postural stability compared to placebo. However, patients should be cautioned about the potential for middle of the night postural instability. Additionally, higher body sway was observed in subjects on Zolpidem therapy in both Middle of the Night & Next Morning Assessments and this finding was statistically significant versus both doses of Dayvigo.
The effect of DAYVIGO on next-day cognitive performance (tests of attention and memory) compared to placebo was evaluated in 2 randomized, placebo-controlled clinical studies. DAYVIGO had no significant effects on cognitive performance compared to placebo.
However, Dayvigo may decrease mental alertness the next day in some patients and in such patients either discontinuation or decrease in dosage to 5 mg should be considered.