DOUBLE-BLIND, PLACEBO-CONTROLLED, CROSS-OVER, STUDY OF ARMODAFINIL TREATMENT OF DAYTIME SLEEPINESS ASSOCIATED WITH TREATED NOCTURIA.

STUDY OBJECTIVES: Nocturia, voids which disturb sleep, is the most common cause of awakenings and is associated with daytime sleepiness. Because the standard treatments for the most common causes of nocturia are relatively ineffective, many treated patients with nocturia are left with residual sleepiness. We carried out this pilot study to evaluate the potential of Armodafinil to be an effective means of addressing the sleepiness that persists in many nocturia patients despite their receiving standard therapy.

METHODS: This was a double-blind, placebo-controlled, cross-over study carried out in 28 patients with nocturia who were receiving standard clinical therapy for their nocturia and who had an Epworth Sleepiness Scale Score (ESS) of at least 10. Subjects received 4 weeks of both armodafinil (150-250 mg) and placebo with order randomized.

RESULTS: Armodafinil led to statistically significant improvement in sleepiness compared with placebo as indicated by the ESS (the primary outcome) (p<0.002) as well as the Clinical Global Impression of Improvement in Sleepiness scale (key secondary outcome) (p=0.01). Armodafinil did not increase nocturic events or significantly increase adverse effects vs placebo.

CONCLUSIONS: This pilot study, the first double-blind, placebo-controlled trial assessing whether a wake-promoting therapy can improve residual daytime sleepiness in patients with treated nocturia, indicates the promise of armodafinil for addressing this residual sleepiness and provides impetus to carry out a large-scale study to definitively evaluate whether armodafinil is an effective therapy for the many patients with nocturia who experience daytime sleepiness that persists despite their receiving standard therapy for this condition.