Adjunct armodafinil improves wakefulness and memory in obstructive sleep apnea/hypopnea syndrome.
OBJECTIVE
Armodafinil is the R-enantiomer of racemic modafinil and has a significantly longer half-life than the S-enantiomer. This study evaluated armodafinil 150 mg/day as an adjunct treatment for residual excessive sleepiness in patients with obstructive sleep apnea/hypopnea syndrome (OSA/HS) who were otherwise well controlled with nasal continuous positive airway pressure (nCPAP). We assessed the ability of armodafinil to improve wakefulness and cognition and reduce fatigue in this population.


METHODS
In this 12-week, randomized, double-blind study, patients (n=259) received armodafinil (150 mg) or placebo once daily. Efficacy assessments at baseline and weeks 4, 8, and 12 included the Maintenance of Wakefulness Test (MWT), Clinical Global Impression of Change (CGI-C), Cognitive Drug Research battery, Epworth Sleepiness Scale, and Brief Fatigue Inventory.


RESULTS
At final visit, mean (SD) MWT sleep latency increased from baseline by 2.3 (7.8) min with armodafinil and decreased by 1.3 (7.1) min in the placebo group (P=0.0003). Armodafinil improved clinical condition (CGI-C, 71% vs. 53% for armodafinil and placebo, respectively; P=0.0069). Armodafinil significantly improved episodic secondary memory (P=0.0102) and patient-estimated wakefulness (P<0.01) and reduced fatigue (P<0.05) compared with placebo. Armodafinil did not adversely affect nCPAP use. The most common adverse event associated with armodafinil was headache. Sleep macroarchitecture was not altered by armodafinil.


CONCLUSIONS
Adjunct treatment with armodafinil significantly improved alertness, overall clinical condition, and long-term memory. Armodafinil also reduced fatigue and the impact of sleepiness on daily activities in patients with OSA/HS who have residual excessive sleepiness notwithstanding regular use of nCPAP. Armodafinil was well tolerated.
Hirshkowitz
M
M
Michael E. DeBakey VAMC Sleep Center, Baylor College of Medicine, Houston, TX 77030, USA. maxh@bcm.tmc.edu
Black
J E
JE
Wesnes
K
K
Niebler
G
G
Arora
S
S
Roth
T
T
D000277:Adjuvants, Pharmaceutic / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D001288:Attention / Q000187:drug effects / Q000502:physiology; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D045422:Continuous Positive Airway Pressure; D004311:Double-Blind Method; D005221:Fatigue / Q000517:prevention & control; D005260:Female; D006801:Humans; D008297:Male; D008568:Memory / Q000187:drug effects*; D008875:Middle Aged; D000077408:Modafinil; D011581:Psychological Tests; D012890:Sleep / Q000187:drug effects / Q000502:physiology; D020181:Sleep Apnea, Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome; D014851:Wakefulness / Q000187:drug effects*
D000277:Adjuvants, Pharmaceutic; D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D000077408:Modafinil