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Modafinil Improves Quality Of Life In Obstructive Sleep Apnea Patients: Presented at CHEST

By Peggy Peck
Special to DG News

SAN DIEGO, CA -- November 6, 2002 -- Results of a 12-week randomized trial suggest that modafinil significantly improves wakefulness and quality of life (QOL) and is well tolerated when used as an adjunct to nasal continuous positive airway pressure (nCPAP) therapy in patients with obstructive sleep apnea and residual excessive sleepiness.

Jonathan R.L. Schwartz, MD, of Integris Sleep Disorders Centers of Oklahoma, Oklahoma City, United States, presented the findings at CHEST 2002, the annual meeting of the American College of Chest Physicians.

The researchers recruited 323 patients who were randomized to placebo (n=108), modafinil 200 mg (109) or 400 mg once daily (n=106).
Modafinil doses were titrated from 100 mg/d to 200 mg/d or 400 mg/d within one week. Efficacy outcomes included changes from baseline in objectively measured alertness (Maintenance of Wakefulness Test [MWT]) and subjective sleepiness (Epworth Sleepiness Scale [ESS]) at weeks 4, 8, and 12. Quality of life was evaluated using the Functional Outcomes of Sleep Questionnaire (FOSQ) and nCPAP use and adverse events (AEs) were monitored.

Modafinil significantly improved patients' ability to sustain wakefulness on the MWT compared with placebo (all p<0.001; figure). Modafinil significantly improved wakefulness as measured by ESS scores at all time points (4.5 point decrease at week 12 for both doses) compared with placebo (1.9 point decrease; p<0.0001).

Modafinil was associated with significant improvement in QOL, with greater changes from baseline at week 12 in total FOSQ score (p<0.001) and domain scores for vigilance (p=0.0005), general productivity (p<0.0008), activity level (p<0.03), and intimacy (p<0.03) compared with placebo. Modafinil had no significant effect on nCPAP use.

The most common AEs in the modafinil and placebo groups were headache (26 and 12 percent), nausea (11 and 2 percent), and anxiety (8 and 2 percent).

The study was supported by a grant from Cephalon, Inc., West Chester, Pennsylvania, United States.

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