Efficacy and safety of adjunctive modafinil treatment on residual excessive daytime sleepiness among nasal continuous positive airway pressure-treated japanese patients with obstructive sleep apnea syndrome: a double-blind placebo-controlled study.
STUDY OBJECTIVES
This double-blind study evaluated the efficacy and safety of modafinil for treating excessive daytime sleepiness in Japanese patients with obstructive sleep apnea syndrome (OSAS).


METHODS
Patients with residual excessive sleepiness (Epworth Sleepiness Scale [ESS] ≥ 11) on optimal nasal continuous positive airway pressure (nCPAP) therapy (apnea-hypopnea index ≤ 10) were randomized to either 200 mg modafinil (n = 52) or placebo (n = 62) once daily for 4 weeks. Outcomes included baseline-week 4 changes in ESS total score, sleep latency on maintenance of wakefulness test (SL-MWT), nocturnal polysomnography, Pittsburgh Sleep Quality Index (PSQI), and safety.


RESULTS
All 114 randomized patients completed the study. Mean change in ESS total score (-6.6 vs -2.4, p < 0.001) and SL-MWT (+2.8 vs -0.4 minutes, p = 0.009) were significantly greater with modafinil than with placebo. ESS total score decreased from > 11 to < 11 at the final assessment in 69.2% of modafinil-treated patients and 30.6% of placebo-treated patients (p < 0.001). Corresponding rates at week 1 were 57.7% and 33.9% (p = 0.014). Changes in nocturnal polysomnography, PSQI, and apnea-hypopnea index from baseline to the final assessment were similar in both groups. Adverse drug reactions occurred in 36.5% and 22.6% of patients in the modafinil and placebo groups, respectively (p = 0.146).


CONCLUSIONS
Once-daily modafinil was effective and well tolerated for managing residual daytime sleepiness in Japanese OSAS patients with residual excessive daytime sleepiness on optimal nCPAP therapy.
['Inoue|Yuichi|Y|', 'Takasaki|Yuji|Y|', 'Yamashiro|Yoshihiro|Y|']
D000328:Adult D000368:Aged D001559:Benzhydryl Compounds D003131:Combined Modality Therapy D045422:Continuous Positive Airway Pressure D006970:Disorders of Excessive Somnolence D004311:Double-Blind Method D064420:Drug-Related Side Effects and Adverse Reactions D004562:Electrocardiography D005260:Female D006801:Humans D007564:Japan D008297:Male D008875:Middle Aged D000077408:Modafinil D010808:Physical Examination D017286:Polysomnography D020181:Sleep Apnea, Obstructive D016896:Treatment Outcome D064690:Wakefulness-Promoting Agents D055815:Young Adult
safety modafinil daytime sleepiness obstructive sleep apnea Epworth Sleepiness Scale nasal continuous positive airway pressure maintenance of wakefulness test Randomized clinical trial