Once-Daily Armodafinil Sustains Wakefulness Throughout the Day in Patients With Narcolepsy: Presented at ANA

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Title: Once-Daily Armodafinil Sustains Wakefulness Throughout the Day in Patients With Narcolepsy: Presented at ANA
URL: http://www.pslgroup.com/dg/22D53A.htm
Doctor's Guide
September 23, 2008

By Andrew N. Wilner, MD

SALT LAKE CITY, Utah -- September 23, 2008 -- Armodafinil given once a day maintains wakefulness in patients with narcolepsy, according to research presented at the American Neurological Association (ANA) 133rd Annual Meeting.

Armodafinil is an R-enantiomer of modafinil, a wakefulness-promoting agent approved by the US Food and Drug Administration (FDA) for narcolepsy, shift-work sleep disorder, and obstructive sleep apnea. Modafinil is usually taken once a day, but some patients require a later second dose. Armodafinil received FDA approval in 2007 for the same indications as modafinil.

The current study was a multicentre, randomised, double-blind, placebo-controlled, parallel-group, 12-week evaluation conducted in 47 centres in the United States, Canada, France, Australia, Germany, and Russia. The results were presented on September 22.

The purpose of the study was to determine whether armodafinil can provide sustained wakefulness throughout the day. Patients were aged between 18 and 65 years, had an International Classification of Sleep Disorders diagnosis of narcolepsy, subjective complaints of excessive sleepiness, a mean sleep latency at baseline of <6 minutes as measured by the Multiple Sleep Latency Test, and a Clinical Global Impression of Severity of Illness rating of >4 (moderately ill). Patients with medical or psychiatric disorders that could be responsible for excessive sleepiness were excluded.

The study compared 3 treatment arms: armodafinil 150 mg/day (n = 64), armodafinil 250 mg/day (n = 67), and placebo (n = 63). Patients received a single dose of the study drug at 7 AM and sleep latency was recorded during 6 tests conducted at 2-hour intervals from 9 AM to 7 PM.

At the final visit, mean sleep latency improved throughout the day by 2.8 minutes in patients treated with armodafinil 150 mg/day and by 3.5 minutes in patients treated with armodafinil 250 mg/day. Both were statistically significant compared with placebo (P < .05).

Later in the day (last 4 tests, 1300-1900 hours), armodafinil at 150 mg/day improved mean sleep latency by 2.9 minutes; at the final visit, armodafinil at 250 mg/day improved mean sleep latency by 3.4 minutes with (both P < .05).

At the end of the day (last 3 tests, 1500-1900 hours), armodafinil improved mean sleep latency in the 150-mg group (P < .05), but the improvement in the 250 mg/day group was not statistically significant.

When the less sleepy patients were excluded from the analysis (mean sleep latency of 20 minutes), armodafinil demonstrated a statistically significant improvement in sleep latency at both doses: 150 mg/day and 250 mg/day (P < .01).

The most common adverse effect of armodafinil was headache, occurring in 16% of patients on 150 mg/day and in 28% of those on 250 mg/day. Nausea occurred in 14% of patients on 150 mg/day and in 7% of those on 250 mg/day.

Study author Russell Rosenberg, PhD, Atlanta School of Sleep Medicine and Technology, Atlanta, Georgia, concluded that "Armodafinil offers an advantage to patients with excess sleepiness compared to modafinil by providing efficacy at a lower dose and sustained benefits many hours post-dose."

Funding for this study was provided by Cephalon, Inc.

[Presentation title: Armodafinil Sustains Wakefulness Throughout the Day in Patients With Excessive Sleepiness Associated With Narcolepsy. Abstract M-106]

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