SPECIAL SAFETY STUDIES
Special safety studies – Middle of the night
In a randomized placebo trial in healthy female subjects ≥55 years and males ≥65 years:
Both DAYVIGO™ doses (5 mg and 10 mg) impaired balance (measured by body sway) at 4 hours post-dose compared with placebo.
Attention and memory
DAYVIGO™ was associated with dose-dependent worsening 4 hours post-dose on measures of attention and memory as compared with placebo.
Patients should be cautioned about the potential for middle of the night postural instability, as well as attention and memory impairment.
Awakening to sound
Neither DAYVIGO™ dose demonstrated any meaningful differences in patients’ ability to awaken to sound compared with placebo.
Special safety studies – Next Day
In 2 randomized placebo trials in healthy subjects and insomnia patients ≥55 years of age:
Next-day cognitive performance
There was no difference between DAYVIGO™ (5 mg or 10 mg) and placebo in test of memory.
In a randomized, double-blind, placebo, 4-period crossover study of healthy volunteers (N=48):
DAYVIGO™ at doses of 5 mg and 10 mg did not cause statistically significant impairment in next-morning driving performance in adult or elderly subjects (compared with placebo). However, driving ability was impaired in some subjects taking 10 mg DAYVIGO™. Therefore, patients using the 10 mg dose should be cautioned about the potential for next-morning driving impairment.
Patients should also be cautioned as the risk of impaired driving is increased if DAYVIGO™ is taken with fewer than 7 hours sleep remaining or if a higher than recommended dose is taken.