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

Objective: To assess the continued efficacy of modafinil in the treatment of excessive daytime somnolence (EDS) of narcolepsy. Background: Modafinil 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 modafinil continued on modafinil 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 modafinil (M) at the same dose ( n=30), or placebo (P; n=33). Results: A mean dose of 330 mg of modafinil continued to produce a significant 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). Modafinil had no significant effects on nocturnal sleep, blood pressure, heart rate, the electrocardiogram (ECG), weight, or mood. Conclusion: Modafinil continues to be an effective and well-tolerated drug after 16 weeks of treatment.