Modafinil as Adjunct Therapy for Daytime Sleepiness in Obstructive Sleep Apnea

Abstract

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.

Modulation of the Acoustic Startle Response by the Level of Arousal: Comparison of Clonidine and Modafinil in Healthy Volunteers

“…In the latter study it was suggested that a sleep-deprivation protocol would be necessary to observe alertness-enhancing effects in healthy volunteers, because modafinil at a dosage of 200 mg has been effective in promoting alertness when healthy volunteers were sleepdeprived (Wesensten et al, 2002;Walsh et al, 2004). It has also been found to be alerting in patients with reduced baseline alertness levels (US Modafinil in Narcolepsy Multicentre Study Group, 1998Group, , 2000Pack et al, 2001;Rammohan et al, 2002;Szabadi et al, 2002;Rosenthal and Bryant, 2004). However, the present study has demonstrated that the larger dose of 400 mg is sufficient for the observation of an alerting effect in a small group of healthy volunteers.…”

Recognizing and Managing Obstructive Sleep Apnea in Primary Care

“…[78][79][80] Modafinil and armodafinil are generally well tolerated in patients with OSA. [81][82][83][84] It is important to note, however, that neither modafinil nor armodafinil addresses the underlying obstruction that causes OSA and must be used in conjunction with CPAP to avoid the return of symptoms and cardiovascular complications. Patients should be counseled to ensure compliance with CPAP when using adjunctive pharmacotherapy.…”

Obstructive Sleep Apnea: Part Ii. Treatment Modalities.

“…Due to lack of controlled trials with long term follow up, modafinil is currently not recommended in untreated patients with OSA. 43,44 Oxygen is sometimes used in patients with central apnea caused by heart failure. It is not used to treat obstructive sleep apnea.…”