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driving

Driving performance

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.

stablity

Postural stability

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. The elderly may be
at higher risk of falls.

cognitive

Cognitive performance

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 decreases mental alertness the next day. Discontinue or decrease dosage to 5 mg if daytime somnolence develops. Patients should also be cautioned against operating machinery if DAYVIGO™ is taken with fewer than 7 hours sleep remaining or if a higher than recommended dose is taken. DAYVIGO was associated with dose-dependent worsening on measures of attention and memory as compared to placebo in older subjects
(age 55 years and older).


Sleep disturbance may be the presenting manifestation of a physical and/or psychiatric disorder.
Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the
patient has been carefully evaluated.

DAYVIGO™ is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or
sleep maintenance.

Click here for additional safety information and for a link to the product monograph, discussing
contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical
use.