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Modafinil Adjunctive Therapy Improves Excessive Sleepiness and Functional Status in Obstructive Sleep Apnea: A 12-Month Open-Label Extension Study

VA Medical Center, Houston, TX

PURPOSE: Nothwithstanding regular use of nasal continuous positive airway pressure (nCPAP), some patients with obstructive sleep apnea (OSA) experience residual excessive sleepiness. In double-blind studies, modafinil, a novel wake-promoting agent, significantly improves wakefulness in patients with OSA who regularly use nCPAP. This 12-month open-label extension study evaluated long-term treatment with modafinil for residual excessive sleepiness in patients with OSA who were using nCPAP.

METHODS: Eligible patients from a 12-week, randomized, double-blind, placebo-controlled study were enrolled in a 12-month, open-label extension trial. Modafinil was administered at either 200 mg/day, 300 mg/day, or 400 mg/day (adjusted clinically). Efficacy assessments included the epworth sleepiness scale (ESS) every three months, and the Functional Outcomes of Sleep Questionnaire (FOSQ) at Month 12 (or final visit).

RESULTS: 266 patients entered the open-label period; 175 (66%) completed the study. Modafinil significantly improved self-reporting wakefulness (assessed by ESS), at all time points. Mean changes (±SD) in ESS scores from baseline (baseline score, 14.5±3.6) at Months 3, 6, 9, and 12 were -5.7±4.5, -5.3±4.4, -5.4±4.6, and -4.5±4.7, respectively (p<0.01). Modafinil significantly improved functional status, measured as the mean change from baseline to final visit in the total score on FOSQ (increased 14% from baseline; p<0.01). Long-term modafinil treatment was well tolerated. The most frequently reported adverse events (5%) were infection (11%), nervousness (9%), headache (9%), accidental injury (8%), sinusitis (7%), rhinitis (7%), depression and anxiety (6% each), and insomnia and dizziness (5% each); most were mild or moderate in severity.

CONCLUSIONS: Modafinil increased self-reported wakefulness, improved functional status, and was well-tolerated during 12-months treatment in nCPAP compliant patients with OSA who experienced residual sleepiness.

CLINICAL IMPLICATIONS: Modafinil is effective for long term use as a good adjunctive therapy to augment nCPAP to improve wakefulness and functional status in patients with OSA.

DISCLOSURE: M. Hirshkowitz, None. Supported by Cephalon, Inc., West Chester, PA