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Clinical Trial
. 2010 Oct 15;6(5):458-66.

The long-term tolerability and efficacy of armodafinil in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work disorder, or narcolepsy: an open-label extension study

Jed E Black  1 , Steven G Hull, Jane Tiller, Ronghua Yang, John R Harsh
Affiliations
Clinical Trial

The long-term tolerability and efficacy of armodafinil in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work disorder, or narcolepsy: an open-label extension study

Jed E Black et al. J Clin Sleep Med. .

Abstract

Study objectives: Armodafinil is a wakefulness-promoting medication. Its efficacy and tolerability have been established in 12-week studies of patients with excessive sleepiness (ES) associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy. This study evaluated the tolerability and efficacy of armodafinil for > or = 12 months.

Methods: Patients with ES associated with treated OSA, SWD, or narcolepsy who completed one of four 12-week, double-blind studies were eligible for this multicenter, open-label study of > or = 12 months' duration of treatment with armodafinil (50 to 250 mg/day). Adverse events and other criteria of tolerability were monitored throughout the study. Efficacy assessments included the Clinical Global Impression of Change (CGI-C), Brief Fatigue Inventory (BFI), and Epworth Sleepiness Scale (ESS).

Results: Of 743 enrolled patients (474 with treated OSA, 113 with SWD, and 156 with narcolepsy), 57% of patients (420/743) completed 12 months or more of treatment. Discontinuations due to adverse events occurred in 13% of patients (95/743) during the initial 12-month period. Throughout the > or = 12-month study, adverse events were generally of mild-to-moderate intensity; headache (25% [180/731]), nasopharyngitis (17% [123/731]), and insomnia (14% [99/731]) were the most common. Modest increases were observed in vital sign measurements (blood pressure [3.6/2.3 mm Hg], heart rate [6.7 beats per minute]) across all patient groups; most of the changes occurred by month 3. Improvements from baseline in efficacy assessments started at month 1 and were maintained throughout the study.

Conclusions: Armodafinil remained effective and was generally well tolerated. Increased monitoring of blood pressure may be appropriate in patients on armodafinil. Armodafinil represents an option for long-term treatment of patients with ES associated with treated OSA, SWD, or narcolepsy.

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Figures

Figure 1
Figure 1
Patient disposition by diagnosis group for patients who completed the 12-month period
Figure 2
Figure 2
Percentage of patients with at least minimal improvement on the Clinical Global Impression of Change (CGI-C) across visits
Figure 3
Figure 3
Epworth Sleepiness Scale (ESS) total scores (mean ± SEM) across visits
Figure 4
Figure 4
Global Brief Fatigue Inventory (BFI) scores (mean ± SEM) across visits
Figure 5
Figure 5
Worst Brief Fatigue Inventory (BFI) scores (mean ± SEM) across visits
See this image and copyright information in PMC

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