Adjunct Therapy for Daytime Sleepiness in Obstructive Sleep Apnea.
Pack AI, Black JE, Schwartz JR, Matheson JK.
Center for Sleep and Respiratory Neurobiology,
University of Pennsylvania, Philadelphia, Pennsylvania; Stanford Sleep Disorders Clinic, Stanford,
Integris Sleep Disorders Centers of Oklahoma, Oklahoma City,
Oklahoma; and Sleep Disorders Center, Beth Israel Deaconess Medical Center,
Am J Respir Crit Care Med 2001 Nov 1;164(9):1675-1681
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.