ABSTRACT
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.
ABSTRACT
Mood changes following ingestion of dextroamphetamine (D-AMP) or methylphenidate (MPH) were examined in 40 narcoleptic patients. The Profile of Mood Status (POMS) and eight additional adjectives describing feelings were used to quantify changes in mood before taking stimulant medication and approximately 90 minutes after ingestion of medication. No significant differences were found between the effects of the two stimulants. When the data from D-AMP and MPH were combined, significantly higher ratings on the POMS factor of Vigour-Activity and the adjectives of 'confident', 'talkative' and 'competitive' were found. Lower ratings after medication were noted for the POMS factors of Fatigue-Inertia, Depression-Dejection and Confusion-Bewilderment (all P < 0.001). These effects are similar to those previously reported in normal subjects as well as in certain other patient populations. The findings indicate a possible therapeutic role of stimulant medication not only for the treatment of excessive sleepiness but also for improving affect, motor and mental vigour, and aspects of cognition.
