Modafinil as adjunct therapy for daytime sleepiness in obstructive sleep apnea

Patients with obstructive sleep apnea/hypopnea syndrome can experience resi dual daytime sleepiness despite regular use of nasal continuous positive ai rway pressure therapy. This randomized, double-blind, placebo-controlled, p arallel group study assessed the efficacy and safety of modafinil for the t reatment 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 dayt ime sleepiness, with significantly greater mean changes from baseline in Ep worth 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 mea n duration of nCPAP use was 6.2 h/night, with no significant change from ba seline observed between groups. Modafinil may be a useful adjunct treatment for the management of residual daytime sleepiness in patients with obstruc tive sleep apnea/hypopnea syndrome who are regular users of nasal continuou s positive airway pressure therapy.