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

Abstract

Modafinil maintains therapeutic efficacy and safety in the treatment of excessive daytime somnolence associated with narcolepsy over extended periods. Following sixteen weeks of open-label treatment at a mean daily dose of 330 mg, sixty-nine patients participated in a two-week randomized, double-blind, placebo-controlled withdrawal phase. Continued modafinil administration resulted in significantly longer mean sleep onset latencies on the Maintenance of Wakefulness Test (16.4 ± 13.7 minutes) compared to placebo (9.7 ± 7.9 minutes). Subjective assessments via the Epworth Sleepiness Scale and patient diaries also demonstrated superior control of somnolence and a reduction in sleep attacks for those remaining on the medication. The drug produced no clinically significant changes in nocturnal sleep architecture, blood pressure, heart rate, or body weight. Furthermore, evaluations using the Profile of Mood States indicated no adverse effects on psychological well-being or evidence of mood alterations upon drug discontinuation. These findings suggest that modafinil does not induce pharmacological tolerance and remains a well-tolerated, effective long-term intervention for managing pathological sleepiness without the cardiovascular or psychological side effects typical of traditional stimulants. – AI-generated abstract.