HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:
Guest Access | Sign In via User Name/Password

This Article Full Text Free Full Text (PDF) Free Submit a response Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Add to My Personal Article Archive Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via ISI Web of Science (27) Citing Articles via Google Scholar Google Scholar Articles by Schwartz, J. R. L. Articles by Schmidt-Nowara, W. Search for Related Content PubMed PubMed Citation Articles by Schwartz, J. R. L. Articles by Schmidt-Nowara, W.

Modafinil as Adjunct Therapy for Daytime Sleepiness in Obstructive Sleep Apnea^*

A 12-Week, Open-Label Study

Jonathan R. L. Schwartz, MD; Max Hirshkowitz, PhD; Milton K. Erman, MD and Wolfgang Schmidt-Nowara, MD; for the United States Modafinil in OSA Study Group

^* From Integris Southwest and Baptist Medical Centers (Dr. Schwartz), Oklahoma City, OK; Veterans Affairs Medical Center (Dr. Hirshkowitz), Houston, TX; Pacific Sleep Medicine Service (Dr. Erman), La Jolla, CA; and Sleep Medicine Institute (Dr. Schmidt-Nowara), Dallas, TX. Members of group listed in ^Appendix.

Correspondence to: Jonathan R. L. Schwartz, MD, Integris Sleep Disorders Center of Oklahoma, 4200 S. Douglas, Suite 313, Oklahoma City, OK 73109; e-mail: SchwJR{at}integris-health.com

Study objectives: The purpose of this 12-week study was to evaluate the efficacy and safety of adjunct modafinil to treat excessive sleepiness in patients with obstructive sleep apnea (OSA) who experience residual sleepiness despite regular nasal continuous positive airway pressure (nCPAP) use.

Design: Twelve-week, open-label trial.

Setting: Twenty-two centers in the United States.

Patients: We studied 125 patients with moderate-to-severe OSA (ie, respiratory disturbance index 15) before nCPAP therapy and residual daytime sleepiness (Epworth sleepiness scale [ESS] score 10) despite effective and regular nCPAP therapy. Patients were studied after completing a 4-week, double-blind, placebo-controlled trial of nCPAP plus modafinil for the treatment of residual daytime sleepiness.

Interventions and measurements: Patients received individually titrated doses of modafinil (200 to 400 mg qd). Sleepiness was assessed using the ESS, quality of life was evaluated using the Functional Outcomes of Sleep Questionnaire (FOSQ), and the overall clinical effect was indexed using the clinical global impression of change scale. Adverse events, nCPAP use, and vital sign measurements were also recorded.

Results: The significant improvements in daytime wakefulness and sleep-related functional status observed with modafinil treatment during the 4-week, double-blind study were maintained throughout 12 weeks of open-label treatment: week 12 ESS, 7.8 (4.7) vs 14.4 (3.1) at double-blind baseline; week 12 FOSQ, 3.3 (0.6) vs 14.4 (2.7) at double-blind baseline (mean [SD]). The percentage of patients rated as clinically improved increased from 83% after 1 week to 93% after 2 to 12 weeks of open-label treatment. Mean (SD) nCPAP use decreased from 6.3 (1.3) h/night at baseline to 5.9 (1.4) h/night (p = 0.004) during open-label treatment. The most common adverse events were headache (28%), anxiety (16%), and nervousness (14%).

Conclusions: 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.

Key Words: continuous positive airway pressure • modafinil • obstructive sleep apnea • quality of life • sleepiness • wakefulness

This article has been cited by other articles:

				K R Kaufman and R Gerner Modafinil in sports: ethical considerations Br. J. Sports Med., April 1, 2005; 39(4): 241 - 244. [Abstract] [Full Text] [PDF]