Modafinil as adjunct therapy for daytime sleepiness in obstructive sleep apnea.
Patients with obstructive sleep apnea/hypopnea syndrome can experience residual daytime sleepiness despite regular use of nasal continuous positive airway pressure therapy. This randomized, double-blind, placebo-controlled, parallel group study assessed the efficacy and safety of modafinil for the treatment of residual daytime sleepiness in such patients. Patients received modafinil (n = 77) (200 mg/d, Week 1; 400 mg/d, Weeks 2 to 4) or matching placebo (n = 80) once daily for 4 wk. Modafinil significantly improved daytime sleepiness, with significantly greater mean changes from baseline in Epworth Sleepiness Scale scores at Weeks 1 and 4 (p < 0.001) and in multiple sleep latency times (MSLT) at Week 4 (p < 0.05). The percentage of patients with normalized daytime sleepiness (Epworth score < 10) was significantly higher with modafinil (51%) than with placebo (27%) (p < 0.01), but not for MSLT (> 10 min; 29% versus 25%). Headache (modafinil, 23%; placebo, 11%; p = 0.044) and nervousness (modafinil, 12%; placebo, 3%; p = 0.024) were the most common adverse events. During modafinil or placebo treatment, the mean duration of nCPAP use was 6.2 h/night, with no significant change from baseline observed between groups. Modafinil may be a useful adjunct treatment for the management of residual daytime sleepiness in patients with obstructive sleep apnea/hypopnea syndrome who are regular users of nasal continuous positive airway pressure therapy.
Pack
A I
AI
Center for Sleep and Respiratory Neurobiology, University of Pennsylvania, Philadelphia, Pennsylvania 19104, USA. pack@mail.med.upenn.edu
Black
J E
JE
Schwartz
J R
JR
Matheson
J K
JK
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003257:Consumer Product Safety; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D017286:Polysomnography; D011175:Positive-Pressure Respiration; D012720:Severity of Illness Index; D020181:Sleep Apnea, Obstructive / Q000188:drug therapy*; D012894:Sleep Stages / Q000187:drug effects*; D018709:Statistics, Nonparametric
D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D000077408:Modafinil