Provigil and shift work
During this 23-day study, a wide selection of food items and beverages were freely available. During this double-blind, within-participant study, volunteers (N=11) received oral Provigil dose (0, 200, or 400 mg) 1 h after waking for three consecutive days under two shift conditions: day shift and night shift. Shifts alternated three times during the study, and shift conditions were separated by an “off” day.
Provigil (200, 400 mg) dose-dependently decreased total caloric intake by ~18% and ~38%, respectively, regardless of shift condition, without selectively altering the proportion of total calories derived from carbohydrate, fat and protein. Ratings of “Hungry” were also significantly decreased by both active doses, but only immediately before the lunch break period.
Mental work and Provigil
Forty-one military subjects received either 300 mg of Provigil Generic, 20 mg of d-amphetamine, or placebo on 3 separate occasions during 64 hours of continuous cognitive work and sleep loss. Three drug treatments were given: at 23.30 hours and 05.30 hours during the first and second SD nights, respectively, and once at 15.30 hours during the third day of continuous work.
Subjective estimates of mood, fatigue and sleepiness, as well as objective measures of reaction time, logical reasoning and short-term memory clearly showed better performance with both Provigil Generic and amphetamine relative to placebo. Both Provigil Generic and amphetamine maintained or increased body temperature compared to the natural circadian cycle observed in the placebo group. Also, from subject debriefs at the end of the study, Provigil Generic elicited fewer side-effects than amphetamine, although more than the placebo group.
Provigil and weight loss or gain
Provigil – Risk for Skin Rash
Rare cases of life-threatening rash, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms have been reported in adults and children during worldwide postmarketing use of Provigil Generic.
The incidence of SJS and TEN exceeds the background rate (1 – 2 cases/million-person years) despite likely underreporting. Cases of angioedema and sometimes fatal multiorgan hypersensitivity reactions have also been reported.
Patients should be instructed to immediately discontinue therapy and contact their healthcare professional if a rash or other hypersensitivity reaction occurs, according to an alert sent from MedWatch, the FDA’s safety information and adverse event reporting program.