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.
RESEARCH DESIGN AND 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.
MAIN OUTCOME MEASURES: 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.