Narcolepsy, armodafinil treatment

The approval of armodafinil marked a significant advance in the treatment of narcolepsy. In this chapter, the pharmacological profile and syntheses of modafinil 4 and armodafinil 1 are profiled in detail.16... 

The armodafinil development program was very similar to the development program previously undertaken for modafinil (or racemic API). Four double-blind and two opened-label clinical trials (1090 patients enrolled with 645 receiving active treatment with armodafinil and 445 receiving placebo) have evaluated the efficacy and safety of armodafinil for the treatment of excessive sleepiness (ES) associated with obstructive sleep apnea (OSA), shift-work disorder (SWD), and narcolepsy.24... 

Armodafinil was also evaluated at 150 or 250 mg/day in 196 narcolepsy patients,24 with or without cataplexy, with associated ES. For this particular trial, the MWT was conducted in standard fashion but extended later in the day to examine the potential for armodafinil to improve alertness. The MWT data at 09 00-15 00 h were combined for both treatment groups and showed an increase of 1.9 min for armodafinil compared with a decrease of 1.9 min for placebo (p < 0.01). MWT sleep latency showed significant improvement relative to placebo with a difference of 2.8 min. (p < 0.05). 

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