Armodafinil.

Area of Science:

• Neuroscience
• Pharmacology
• Sleep Medicine

Background:

• Armodafinil, the R-enantiomer of modafinil, is a wake-promoting agent targeting brain regions controlling alertness.
• Excessive sleepiness is a significant symptom in conditions such as obstructive sleep apnea/hypopnea syndrome (OSA), narcolepsy, and shift work sleep disorder (SWSD).

Purpose of the Study:

• To evaluate the efficacy and tolerability of once-daily armodafinil in adult patients experiencing excessive sleepiness.
• To assess armodafinil's impact on objective and subjective measures of wakefulness in patients with OSA, narcolepsy, and SWSD.

Main Methods:

• Four large, multinational, double-blind, placebo-controlled trials of 12 weeks' duration were conducted.
• Participants included adult patients diagnosed with excessive sleepiness associated with OSA (despite treatment), narcolepsy, or SWSD.
• Efficacy was assessed using the Multiple Sleep Latency Test (MSLT), Maintenance of Wakefulness Test (MWT), and the Clinical Global Impressions of Change (CGI-C) scale.

Main Results:

• Once-daily armodafinil (150 or 250 mg) significantly improved mean sleep latency compared to placebo in patients with OSA and narcolepsy.
• Armodafinil 150 mg once daily significantly improved mean sleep latency in patients with SWSD.
• A significantly higher proportion of armodafinil recipients achieved a clinical response (CGI-C) compared to placebo recipients.

Conclusions:

• Once-daily armodafinil is an effective treatment for improving wakefulness in adult patients with excessive sleepiness due to OSA, narcolepsy, or SWSD.
• Armodafinil was generally well-tolerated in the studied patient populations.