title: The efficacy and safety of armodafinil as treatment for adults with excessive sleepiness associated with narcolepsy.
abstract: OBJECTIVE
  This study assessed the efficacy and safety of armodafinil, the longer half-life enantiomer of modafinil, for the treatment of excessive sleepiness in patients with narcolepsy.
  
  
  METHODS
  This was a multicenter double-blind study with 196 patients (aged 18-65 years) randomized to receive armodafinil 150 mg (n = 65), armodafinil 250 mg (n = 67), or placebo (n = 64) once daily for 12 weeks.
  
  
  METHODS
  Efficacy was assessed using the Maintenance of Wakefulness Test (MWT) (six 20-min subtests across the day), the Clinical Global Impression of Change (CGI-C), subjective measures of sleepiness (Epworth Sleepiness Scale), patient diaries, and evaluations of cognitive performance (Cognitive Drug Research) and fatigue (Brief Fatigue Inventory).
  
  
  RESULTS
  Armodafinil significantly increased MWT mean sleep latency (at 0900-1500) compared with placebo. The mean change from baseline at final visit for armodafinil was an increase of 1.3, 2.6, and 1.9 min in the 150-mg, 250-mg, and combined groups, respectively, compared with a decrease of 1.9 min for placebo (p < 0.01 for all three comparisons). Mean late-day MWT latency (1500-1900) was also significantly improved (difference of armodafinil combined group relative to placebo at final visit: 2.8 min, p = 0.0358). The proportions of patients who showed at least minimal improvement in the CGIC rating from baseline to final visit in the armodafinil 150-mg, 250-mg, and combined groups were 69%, 73%, and 71%, respectively, compared with 33% for placebo (p < 0.0001). Both doses were associated with statistically significant improvements in memory, attention, and fatigue (p < 0.05). The most common adverse events in patients receiving armodafinil were headache, nausea, and dizziness.
  
  
  CONCLUSIONS
  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.
authors: The University of Southern Mississippi, Hattiesburg, MS 39406, USA. john.harsh@usm.edu
authors: John R
authors: JR
authors: Harsh
authors: Roza
authors: R
authors: Hayduk
authors: Russell
authors: R
authors: Rosenberg
authors: Keith A
authors: KA
authors: Wesnes
authors: James K
authors: JK
authors: Walsh
authors: Sanjay
authors: S
authors: Arora
authors: Gwendolyn E
authors: GE
authors: Niebler
authors: Thomas
authors: T
authors: Roth