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Am. J. Respir. Crit. Care Med., Volume 164, Number 9, November 2001, 1675-1681

Modafinil as Adjunct Therapy for Daytime Sleepiness in Obstructive Sleep Apnea

ALLAN I. PACK, JED E. BLACK, JONATHAN R. L. SCHWARTZ, and JEAN K. MATHESON, for the U.S. Modafinil in Obstructive Sleep Apnea Study Group

Center for Sleep and Respiratory Neurobiology, University of Pennsylvania, Philadelphia, Pennsylvania; Stanford Sleep Disorders Clinic, Stanford, California; Integris Sleep Disorders Centers of Oklahoma, Oklahoma City, Oklahoma; and Sleep Disorders Center, Beth Israel Deaconess Medical Center, Boston, Massachusetts

Patients with obstructive sleep apnea/hypopnea syndrome can experience residual daytime sleepiness despite regular use of nasal continuous positive airway pressure therapy. This randomized, double-blind, placebo-controlled, parallel group study assessed the efficacy and safety of modafinil for the treatment of residual daytime sleepiness in such patients. Patients received modafinil (n = 77) (200 mg/d, Week 1; 400 mg/d, Weeks 2 to 4) or matching placebo (n = 80) once daily for 4 wk. Modafinil significantly improved daytime sleepiness, with significantly greater mean changes from baseline in Epworth Sleepiness Scale scores at Weeks 1 and 4 (p < 0.001) and in multiple sleep latency times (MSLT) at Week 4 (p < 0.05). The percentage of patients with normalized daytime sleepiness (Epworth score < 10) was significantly higher with modafinil (51%) than with placebo (27%) (p < 0.01), but not for MSLT (> 10 min; 29% versus 25%). Headache (modafinil, 23%; placebo, 11%; p = 0.044) and nervousness (modafinil, 12%; placebo, 3%; p = 0.024) were the most common adverse events. During modafinil or placebo treatment, the mean duration of nCPAP use was 6.2 h/night, with no significant change from baseline observed between groups. Modafinil may be a useful adjunct treatment for the management of residual daytime sleepiness in patients with obstructive sleep apnea/hypopnea syndrome who are regular users of nasal continuous positive airway pressure therapy.




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