* Recommended Dosage: 200 mg once a day, in the morning (for OSA/HS) or an hour before starting work shift (for SWSD).
* Comment: Approval was based on 12-week placebo-controlled trials of patients with OSA/HS and SWSD. Provigil helped apnea patients with persistent, excessive sleepiness, despite adequate treatment with continuous positive airway pressure (CPAP), said Dr.
Patients with SWSD have trouble with maintaining alertness during nocturnal work shifts or with sleep continuity when they try to sleep during the day.
The company identified three clinical categories of sleep disorders associated with excessive sleepiness for the FDA's consideration: sleep-wake dysregulation (narcolepsy), sleep disruption (obstructive sleep apnea/hypopnea syndrome or OSAHS), and circadian misalignment (shift work sleep disorder or SWSD).
And it voted 6 to 2 in favor of the use of Provigil for treatment of SWSD.