Does short-term treatment with modafinil affect blood pressure in patients with obstructive sleep apnea?
OBJECTIVE
To investigate the effects of modafinil, a central nonamphetamine awakening substance, on blood pressure and heart rate in hypersomnolent patients with obstructive sleep apnea.


METHODS
This double-blind, randomized, placebo-controlled crossover trial was performed over 2 days and 3 nights in a single-center study of hospitalized patients from a referred care center. Twenty-six otherwise healthy men (age range, 30 to 60 years) with mild to moderate obstructive sleep apnea were recruited by the outpatient department of the Marburg University Sleep Laboratory. Patients were given 200 mg oral modafinil in the morning and 100 mg at midday. Placebo was given in the same manner in a crossover design. Mean arterial (radial) blood pressure was monitored continuously during nocturnal sleep and during a series of standardized daytime physical and psychologic performance tests.


RESULTS
The difference in the main end point between the treatment with modafinil and placebo was 1.17+/-0.83 (mean +/- SE) mm Hg (95% confidence interval: -0.56 to 2.91 mm Hg). The maximal differences in blood pressure values occurred under loaded conditions (systolic blood pressure, ergometry: 5.62+/-1.13 mm Hg; mental stress test: 6.19+/-1.33 mm Hg).


CONCLUSIONS
Short-term administration of modafinil did not elicit a significant response with regard to the main end point. However, cardiovascular effects during mental and physical load were observed. Longterm studies that include subjects with hypertension are necessary to investigate the clinical relevance of the cardiovascular effects of modafinil.
Heitmann
J
J
Department of Medicine, Marburg University, Germany. heitmanj@mailer.uni-marburg.de
Cassel
W
W
Grote
L
L
Bickel
U
U
Hartlaub
U
U
Penzel
T
T
Peter
J H
JH
D000328:Adult; D001559:Benzhydryl Compounds / Q000008:administration & dosage / Q000494:pharmacology*; D001794:Blood Pressure / Q000187:drug effects*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000494:pharmacology*; D018592:Cross-Over Studies; D003971:Diastole / Q000187:drug effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D016552:Ergometry; D005260:Female; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D011594:Psychometrics; D012891:Sleep Apnea Syndromes / Q000188:drug therapy* / Q000503:physiopathology*; D013599:Systole / Q000187:drug effects; D016896:Treatment Outcome; D014851:Wakefulness / Q000187:drug effects
D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D000077408:Modafinil