Provigil

Clinical Pharmacology

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Clinical Pharmacology

Provigil

It should be noted that not all patients with a complaint of sleepiness who are also engaged in shift work meet the criteria for the diagnosis of SWSD. In the clinical trial, only patients who were symptomatic for at least 3 months were enrolled.

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 (PSG).

The primary measures of effectiveness were 1) sleep latency, as assessed by the Multiple Sleep Latency Test (MSLT) performed during a simulated night shift at week 12 or the final visit and 2) the change in the patient's overall disease status, as measured by the Clinical Global Impression of Change (CGI-C) at week 12 or the final visit. Patients treated with PROVIGIL showed a statistically significant prolongation in the time to sleep onset compared to placebo-treated patients, as measured by the nighttime MSLT [Table 1] (p< 0.05). Improvement on the CGI-C was also observed to be statistically significant (p< 0.001). (See CLINICAL TRIALS, Narcolepsy section above for a description of these tests.)

Daytime sleep measured with polysomnography was not affected by the use of PROVIGIL.

Table 1. Average Baseline Sleep Latency and Change from Baseline at Final Visit in Adults (MWT and MSLT in minutes)

Disorder	Measure	PROVIGIL 200 mg *		PROVIGIL 400 mg*		Placebo
		Baseline	Change from Baseline	Baseline	Change from Baseline	Baseline	Change from Baseline
Narcolepsy I	MWT	5.8	2.3	6.6	2.3	5.8	-0.7
Narcolepsy II	MWT	6.1	2.2	5.9	2.0	6.0	-0.7
OSAHS	MWT	13.1	1.6	13.6	1.5	13.8	-1.1
SWSD	MSLT	2.1	1.7	-	-	2.0	0.3
*Significantly different than placebo for all trials (p< 0.01 for all trials but SWSD, which was p< 0.05)

Table 2. Clinical Global Impression of Change (CGI-C) (Percent of Adult Patients Who Improved at Final Visit)

Disorder	PROVIGIL 200 mg*	PROVIGIL 400 mg*	Placebo
Narcolepsy I	64%	72%	37%
Narcolepsy II	58%	60%	38%
OSAHS	61%	68%	37%
SWSD	74%	-------	36%
*Significantly different than placebo for all trials (p< 0.01)