A randomized trial of the long-term, continued efficacy and safety of modafinil in narcolepsy (original) (raw)

Objective: To assess the continued ef®cacy of moda®nil in the treatment of excessive daytime somnolence (EDS) of narcolepsy. Background: Moda®nil has been shown to be a safe and effective treatment for the EDS presented by patients with narcolepsy. However, the duration of treatment has been relatively brief, particularly considering the chronic nature of the disease. Methods: Sixty-nine patients with narcolepsy, who completed a 6-week crossover study of moda®nil continued on moda®nil for 16 weeks of open-label treatment (300^100 mg). This was followed by 2 weeks during which patients were randomly and blindly allocated to continue moda®nil (M) at the same dose (n 30), or placebo (P; n 33). Results: A mean dose of 330 mg of moda®nil continued to produce a signi®cant decrease in EDS as measured by the Maintenance of Wakefulness Test (9.7^7.9 for P; 16.4^13.7 for M; P 0:009), the Epworth Sleepiness Scale (15.4^5.8 for P; 13.2^5.7 for M; P 0:023), and the number of episodes of severe somnolence and sleep reported in patient diaries (8.2^7.2 for P; 4.2^5.2 for M; P 0:017). Moda®nil had no signi®cant effects on nocturnal sleep, blood pressure, heart rate, the electrocardiogram (ECG), weight, or mood. Conclusion: Moda®nil continues to be an effective and well-tolerated drug after 16 weeks of treatment.

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A randomized trial of the long-term, continued efficacy and safety of modafinil in narcolepsy (original) (raw)

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