Provigil Generic

Health Canada approved a new indication for Provigil (Alertec tablets, made by Shire BioChem, Inc), allowing its use for the symptomatic treatment of excessive sleepiness in shift work sleep disorder.

The approval was based on data from a double-blind, 12-week study in 209 patients showing that nightly treatment with 200 mg of Provigil increased sleep latency from baseline (1.7 ± 0.4 vs 0.3 ± 0.3 minutes; P = .002) and improved clinical symptoms in a greater proportion of patients (74% vs 36%; P < .001) compared with placebo.

Provigil-treated patients also experienced a decrease from baseline in the frequency and duration of attention lapses during nighttime testing, contrasting with the increase observed among those receiving placebo (Psychomotor Vigilance Test score, –2.6 vs 3.8; P < .001).
In addition, patients receiving Provigil therapy reported fewer accidents or near misses while driving home from work compared with those receiving placebo (29% vs 54%; P < .001).

The most commonly reported adverse events associated with Provigil therapy were headache (25%) and nausea (9%). Treatment did not adversely affect daytime sleep compared with placebo.

Although 200 mg of Provigil reduced the extreme sleepiness of chronic shift work sleep disorder and resulted in small but significant improvements in performance compared with placebo, patients continued to have residual sleepiness and impaired performance at night. This finding suggests that the therapy is not completely effective and underscores the need for development of more effective interventions.