Modafinil Helpful in Sleep Apnea

Laurie Barclay, MD

December 17, 2003

Dec. 17, 2003 — Modafinil is effective and well tolerated as adjunct therapy for patients with obstructive sleep apnea (OSA), according to the results of a 12-week, open-label study published in the December issue of Chest.

"Modafinil is a novel wake-promoting agent that is chemically dissimilar to and has a pharmacologic profile that differs from central nervous system stimulants," write Jonathan R. L. Schwartz, MD, from Integris Sleep Disorders Center of Oklahoma in Oklahoma City, and colleagues from the United States Modafinil in OSA Study Group. "Short-term treatment with nasal [continuous positive airway pressure] (nCPAP) can reduce residual daytime sleepiness in patients with OSA."

At 22 U.S. centers, 125 patients with moderate-to-severe OSA despite effective and regular nCPAP therapy were studied after completing a four-week, double-blind, placebo-controlled trial of nCPAP plus modafinil for the treatment of residual daytime sleepiness. Before nCPAP therapy, respiratory disturbance index was at least 15 and Epworth sleepiness scale [ESS] score was at least 10.

In an open-label extension of the double-blind trial, patients received individually titrated doses of modafinil, 200 to 400 mg daily, for 12 weeks. Significant improvements in daytime wakefulness and in sleep-related functional status occurred during the double-blind trial and persisted throughout 12 weeks of open-label treatment.

ESS score improved to 7.8 ± 4.7 at week 12 from 14.4 ± 3.1 at baseline, while the Functional Outcomes of Sleep Questionnaire score improved to 3.3 ± 0.6 from 14.4 ± 2.7. On the clinical global impression of change scale, the percentage of patients rated as clinically improved increased from 83% after one week to 93% or more after two to 12 weeks of open-label treatment. Nightly nCPAP use decreased from 6.3 ± 1.3 hours at baseline to 5.9 ± 1.4 hours per night during open-label treatment (P = .004).

Adverse events included headache in 28%, anxiety in 16%, and nervousness in 14%.

"Modafinil remained effective and well tolerated as an adjunct therapy for residual daytime sleepiness even after 12 weeks of daily dosing in patients with OSA receiving nCPAP therapy," the authors write. "Modafinil does not treat the underlying pathophysiology of airway collapse in OSA, so it is not expected that modafinil would have a therapeutic role in patients who are not receiving adequate prophylactic treatment for apneas and hypopneas."

Cephalon, Inc., supported this study. Two authors have served as consultants for Cephalon; three authors are on the speakers' bureau, and one owns stock in Cephalon.

Chest. 2003;124:2192-2199

Reviewed by Gary D. Vogin, MD

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