Obstructive sleep apnea/hypopnea syndrome (OSA/HS) is a serious and chronic disorder characterized by repeated episodes of complete or partial collapse of the upper airway during sleep. The resulting disruption (or fragmentation) of sleep leads to excessive daytime sleepiness.

A relatively common condition, OSA/HS is estimated to affect 2 to 4% of middle-aged adults. Because the disorder has been associated with impairments in neurophysiologic, respiratory, cardiovascular, and cerebrovascular function, patients with OSA/ HS may experience significant morbidity and there is suggestive evidence of increased mortality.

Results from the Sleep Heart Health Study indicate that sleep-disordered breathing is associated with an increased risk for systemic hypertension, and prospective data from the Wisconsin Sleep Cohort Study demonstrate a dose-response association between sleep-disordered breathing at baseline and the presence of hypertension 4 yr later. Other studies have suggested that the incidence rates of occupational accidents and automobile accidents are increased in patients with untreated OSA/HS.

The use of Provigil for other conditions in which there is hypersomnolence has raised interest in its use for the treatment of residual EDS in patients who are receiving effective treatments for OSA/HS. To date, Provigil has been studied in two small pilot trials in patients with OSA/HS, albeit with different doses and designs from those of the present study. Both studies showed that Provigil improved daytime wakefulness but had no significant effect on sleep-disordered breathing or resting blood pressure monitored during the day. Neither study, however, assessed the efficacy and safety of Provigil in patients receiving nCPAP treatment. The present study was undertaken to evaluate the efficacy and safety of Provigil in the treatment of residual EDS in a large population of patients with OSA/HS who were effectively treated with, and regular users of, nCPAP therapy.

The results of the present study only support the use of Provigil as an adjunct treatment for residual daytime sleepiness in patients with OSA/HS who are effectively treated with nCPAP. In this trial, considerable attention was paid to patient selection and the monitoring of nCPAP effectiveness to ensure that the primary pathology of sleep-disordered breathing was appropriately treated. In contrast to the effective use of nCPAP in the prevention of OSA/HS disease progression and the resulting adverse cardiovascular sequelae, Provigil should never be used as a primary treatment of OSA/HS as it has no such anticipated beneficial effects.

In summary, the results of this trial suggest that 400 mg of Provigil taken once daily is an effective and well-tolerated adjunct treatment for residual EDS in patients with OSA/HS who are regular users of nCPAP therapy. The results further suggest that Provigil has no clinically significant effect on RDI, cardiovascular parameters, or nCPAP use.