Health-related quality of life effects of modafinil for treatment of narcolepsy

Objective: To evaluate the burden of illness of narcolepsy and assess the h ealth-related quality-of-life (HQL) effects of oral modafinil, a wake-promo ting therapy for excessive daytime sleepiness associated with narcolepsy. Methods: Subjects with narcolepsy enrolled in a nine-week, placebo-controll ed, double-blind study and were randomized to placebo, modafinil 200 mg, or modafinil 400 mg. After the study, consenting subjects received modafinil in a 40-week open-label extension. A self-administered HQL questionnaire co nsisting of the 36-item Short Form Health Survey (SF-36) and supplemental n arcolepsy-specific scales was given to subjects at baseline, study endpoint , and several open-label timepoints. Results: 481 subjects completed a baseline and double-blind endpoint HQL as sessment. Compared to population norms, baseline HQL scores reflected subst antial burden in vitality, social functioning, and performing usual activit ies. At study endpoint, subjects in the 400 mg modafinil group had signific antly higher scores than placebo for 10 of the 17 HQL scales. The 400 mg mo dafinil group had more energy, fewer difficulties performing usual activiti es, fewer interferences with social activities, improved psychological well -being and higher productivity, attention and self-esteem compared to place bo subjects (p<.05). The positive treatment effects were sustained over the open-label extension. Conclusion: Modafinil significantly improves health-related quality of life in narcolepsy.