Rationale: Patients with obstructive sleep apnea (OSA) unable to tolerate standard treatments have few alternatives. They may benefit from weight loss, but the major symptom of daytime performance impairment may remain during weight loss programs.
Objectives: We hypothesized that wakefulness-promoter armodafinil would improve driving task performance over placebo in patients undergoing weight loss.
Methods: This was a placebo-controlled, double-blind, randomized trial of armodafinil versus placebo daily for 6 months in patients who were also randomized to one of two diets for 6 months with follow-up at 1 year in overweight, adult, patients with OSA who had rejected standard treatment and suffered daytime sleepiness.
Measurements and main results: Primary outcome was change in steering deviation in the final 30 minutes of a 90-minute afternoon driving task (AusED) at 6 months. Secondary outcomes were Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, and fat mass measured by dual-emission X-ray absorptiometry. Armodafinil improved driving task performance over placebo at 3 months (12.9 cm; 95% confidence interval, 4.1-21.7; P = 0.004), but not the primary time point of 6 months (5.5 cm; 95% confidence interval, -3.3 to 14.3; P = 0.223). Patients on armodafinil lost 2.4 kg more fat than those on placebo at 6 months (95% confidence interval, 0.9-4.0; P = 0.002). Other secondary outcomes were not significantly improved.
Conclusions: Armodafinil did not improve driving task performance at the primary endpoint of 6 months. Armodafinil might be a useful adjunctive to weight loss in patients with OSA rejecting conventional treatments but this needs to be directly tested in a specifically designed, properly powered clinical trial. Clinical trial registered with Australian and New Zealand Clinical Trials Registry (ACTRN 12611000847910).
Keywords: disorders of excessive somnolence; drug therapy; obesity management; sleep apnea syndrome.