Expanded indications of Provigil for those with excessive sleepiness associated with OSAHS and SWSD
January 27, 2004
ST. LOUIS (MD Consult) - On January 26, 2004, Cephalon Inc. announced it had received approval from the U.S. Food and Drug Administration to market Provigil (modafinil) [C-IV] Tablets to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) and shift work sleep disorder (SWSD). Originally approved in 1998, Provigil was the first wake-promoting agent approved in the United States for improving wakefulness in patients with narcolepsy. For patients with OSAHS, Provigil is approved as an adjunct to standard treatment for the underlying airway obstruction.
"The approval of Provigil for these conditions provides clinicians with a therapeutic option to treat the debilitating excessive sleepiness that affects the daily lives of patients with obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder," said Paul Blake, MB, FRCP, Senior Vice President of Clinical Research and Regulatory Affairs at West Chester, Pennsylvania?based Cephalon.
Joseph Lieberman, MD, MPH, Professor of Family Medicine, Jefferson Medical College, Philadelphia, added, "Currently, many patients suffer needlessly from excessive sleepiness because they simply don't recognize it as a symptom of a medical condition and therefore don't talk to their doctors about it. Primary care physicians are in a position to identify excessive sleepiness and initiate appropriate diagnosis and care of their patients, including educating them about the dangers of engaging in certain activities while impaired by excessive sleepiness. Now with the approval of Provigil, we have a new treatment option for our patients?when they have been appropriately diagnosed and treatment of their underlying condition does not resolve their excessive sleepiness."
Provigil promotes wakefulness in preclinical studies without causing generalized stimulation in the brain. The drug is believed to work selectively through the sleep/wake centers to activate the cortex of the brain. Activation of the cortex is essential for wakefulness. The exact mechanism of action of Provigil is not known.
The safety of Provigil has been demonstrated in clinical trials enrolling more than 3,500 patients. In studies of OSAHS and SWSD, the overall safety profile of Provigil was demonstrated to be consistent with the profile already established in patients with narcolepsy.
Provigil has been shown to have no effect on a patient's ability to sleep when sleep is desired. Studies have demonstrated that the sleep of patients taking Provigil was of similar quality and quantity to individuals taking placebo. In clinical trials, Provigil was well tolerated, with an incidence of adverse events generally comparable to placebo. Most adverse events were mild to moderate. The most frequently reported adverse events were headache, nausea, nervousness, diarrhea, anxiety, dizziness, back pain, stuffy nose, trouble sleeping, and upset stomach.
Excessive sleepiness is the primary symptom?and often the most debilitating feature?associated with OSAHS, SWSD, and narcolepsy. Excessive sleepiness is defined as difficulty in maintaining wakefulness and an increased likelihood of falling asleep in inappropriate situations.
In OSAHS, sleep disruption is most commonly caused by airway obstruction, usually the relaxation and collapse of the soft tissue in the back of the throat during sleep. Symptoms of OSAHS may include restless sleep, obesity, irritability, forgetfulness, morning headaches, loss of energy, trouble concentrating, mood or behavior changes, anxiety or depression, falling asleep during the day (e.g., at work, watching TV), and loud, heavy snoring (often interrupted by silence and then gasps). According to the National Institutes of Health, approximately 12 million Americans suffer from OSAHS, and the disorder is twice as common in men as in women.
Continuous positive airway pressure, a medical device that blows air through the nasal passage, is the primary treatment for OSAHS. Despite adequate regular use of continuous positive airway pressure, many patients continue to experience excessive sleepiness. For these patients, Provigil may be an appropriate adjunctive treatment.
SWSD is defined as a persistent or recurrent pattern of sleep disruption leading to excessive sleepiness or insomnia that is due to a mismatch between the sleep-wake schedule required by a person's environment and his or her circadian sleep-wake pattern. Characterized by extreme sleepiness, insomnia, headaches, and difficulty concentrating, SWSD can affect those who frequently rotate shifts or work at night. Six million people in the United States work permanent or rotating night shifts and therefore are at risk for SWSD.
Provigil is supplied as oral tablets containing either 100 or 200 mg of modafinil. The recommended dose of Provigil is 200 mg once daily. For patients with narcolepsy and OSAHS, Provigil should be taken as a single dose in the morning. Patients with SWSD should take Provigil approximately 1 hour before the start of their work shifts
(That's about 80 cups of coffee 
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