Provigil

Narcolepsy

• Two US 9‑week, multicenter, placebo‑controlled, parallel-group, double‑blind studies evaluated the efficacy of Provigil for improving wakefulness in 558 adult outpatients with excessive sleepiness associated with narcolepsy. Patients were randomly assigned to receive Provigil 200 or 400 mg/day, or placebo.

• All eligible patients were required to have objectively documented excessive daytime sleepiness, via a Multiple Sleep Latency Test (MSLT) with 2 or more sleep onset REM periods and the absence of any other clinically significant active medical or psychiatric disorder. 

• In both studies, the primary measures of effectiveness were: 1) sleep latency, as assessed by the Maintenance of Wakefulness Test (MWT); and 2) the change in the patient’s overall disease status, as measured by the Clinical Global Impression of Change (CGI-C). For a successful trial, both measures had to show statistically significant improvement.

• Results from both studies showed that treatment with Provigil 200 mg and 400 mg achieved improvement in objective and subjective measures of excessive daytime sleepiness compared with placebo. 

• Provigil 200 mg and 400 mg doses achieved a statistically significantly enhanced ability to remain awake on the MWT at each dose compared to placebo at final visit. Each dose of Provigil also had a statistically significantly greater number of patients with improvement in overall clinical condition as rated by the Clinical Global Impression of Change (CGI-C) scale at final visit.

Obstructive Sleep Apnea (OSA)

Two multicenter, placebo-controlled clinical studies evaluated the efficacy and safety of Provigil for improving wakefulness in adults with excessive sleepiness associated with OSA. 

Study 1

• 327 patients with OSA were randomly assigned to receive Provigil 200 mg/day, 400 mg/day, or placebo for 12 weeks. The primary measures of effectiveness were 1) sleep latency, as assessed by the MWT and 2) the change in the patient’s overall disease status, as measured by the CGI-C at the final visit. 

• Treatment with Provigil achieved a statistically significant improvement in the ability to remain awake compared with placebo, as measured by the MWT at final visit. There was also a greater number of patients treated with Provigil who achieved statistically significant improvement in overall clinical condition as rated by the CGI-C scale at final visit.

Study 2

• 157 patients with OSA were randomly assigned to Provigil 400 mg/day or placebo for 4 weeks. The primary measure of effectiveness was the change from baseline on the ESS at final visit. 

• At week4, treatment with Provigil reduced the ESS score by 4.6 compared with a reduction of 2.0 in the placebo group.

Shift Work Disorder (SWD)

• A 12-week placebo-controlled clinical trial evaluated the efficacy of Provigil in improving wakefulness in 209 patients with excessive sleepiness associated with SWD. Patients were randomly assigned to receive Provigil 200 mg/day or placebo.

• Enrolled patients were also required to work a minimum of 5 night shifts per month, have excessive sleepiness at the time of their night shifts (MSLT score < 6 minutes), and have daytime insomnia documented by a daytime polysomnogram.

• The primary measures of effectiveness were 1) sleep latency, as assessed by the MSLT performed during a simulated night shift at the final visit and 2) the change in the patient’s overall disease status, as measured by the CGI-C at the final visit.

• Results showed that treatment with Provigil achieved a statistically significant prolongation in the time to sleep onset compared to placebo-treated patients, as measured by the nighttime MSLT at final visit. Treatment with Provigil also had a statistically significant greater number of patients who improved in overall clinical condition as rated by the CGI-C scale at final visit.