The efficacy and safety of armodafinil as treatment for adults with excessive sleepiness associated with narcolepsy

Abstract

Armodafinil significantly improved ability to sustain wakefulness throughout the day in patients with narcolepsy. Armodafinil also significantly improved overall clinical condition, memory, attention, and fatigue when compared with placebo.

Clinical features, diagnosis and treatment of narcolepsy

“…A more recent multicentre double-blind study with 196 patients by Harsh et al 37 showed that armodafanil (R-modafanil: an enantiomer of the racemic compound modafinil, with a longer half-life of 10-14 hours) significantly increased MWT mean sleep latency compared with placebo. The mean increase from baseline to final visit for armodafinil was 1.3, 2.6 and 1.9 minutes in the 150mg, 250mg, and 150 and 250mg combined groups, respectively, compared with a decrease of 1.9 minutes for placebo (p<0.01 for all three comparisons).…”

Pharmacotherapy of Excessive Sleepiness: Focus on Armodafinil

“…[37][38][39][61][62][63] A summary of the results of these clinical trials is given in Tables 2 and 3. In addition, there are two ongoing open-label trials of armodafi nil: one in trial-naïve patients (with narcolepsy, OSA, or SWD) and one extension study in patients who completed any of the randomized trials and were able to participate for 12 months or longer.…”

“…Night-time sleep was not affected in patients administered armodafi nil. 37 Obstructive sleep apnea OSA is a sleep disorder characterized by episodes of partial or complete collapse of the airway and is associated with increased morbidity and mortality. 69 The most common symptom of OSA is ES.…”

“…A 12-week, randomized, doubleblind, placebo-controlled trial of armodafinil 150 mg or 250 mg once daily in the treatment of ES associated with narcolepsy was conducted in 47 centers located across the USA, Canada, France, Australia, Germany, and Russia. 37 Patients with or without cataplexy were permitted to enroll in the study provided that they were on a stable dose of anticataplectic medicine and were not taking sodium oxybate; patients were excluded if they were receiving melatonin or sedatives such as barbiturates, benzodiazepines, and zolpidem. Patients were randomized to receive armodafi nil 150 mg (n = 64), 250 mg (n = 67), or placebo (n = 63).…”

“…34,35 The prolonged circulation of R-modafi nil may mean that the majority of effects attributed to modafi nil are due to R-modafi nil; this hypothesis resulted in further investigation of R-modafi nil (armodafi nil) in patients with a variety of disorders. [37][38][39] Further to this, armodafi nil was approved by the Food and Drug Administration in June 2007 for the improvement of wakefulness in patients with ES as a result of OSA, narcolepsy, and SWD. …”