PHILADELPHIA – Modafinil in patients with obstructive sleep apnea and excessive daytime sleepiness despite positive airway pressure therapy was effective in improving wakefulness for at least 17 weeks in a small study presented at the annual meeting of the Associated Professional Sleep Societies.
Previous studies of the wakefulness drug and obstructive sleep apnea (OSA) had been limited to 12 weeks, Juan Moralejo, M.D., reported.
“In our study population, modafinil was more likely to be effective in the elderly and those with high Epworth Sleepiness Scale scores at the time of diagnosis” of daytime sleepiness, said Dr. Moralejo, a pulmonary medicine fellow at Graduate Hospital, Philadelphia.
The study sample consisted of 22 patients (13 males and 9 females), mean age 53.9 years. Of the 18 patients receiving “conventional treatment,” 9 were using continuous positive airway pressure, 8 were using bilevel positive airway pressure, and 1 was using a dental device. At the time of the survey, four patients were not using any conventional treatment for OSA.
The mean Epworth Sleepiness Scale score was 15.9 at diagnosis, 13.6 after treatment with conventional modalities, and 8.9 after treatment with modafinil (Provigil). A lower Epworth score is indicative of improved wakefulness, and reduction of 4 points is considered a response to treatment. No statistical difference was found between the Epworth scores before and after conventional treatment, but the change after modafinil treatment was significant, Dr. Moralejo said.
The improvement in Epworth Sleepiness Scale score was similar whether patients were on modafinil for more than or less than 12 weeks. The average duration of treatment was 17 weeks (range 1–40).
On univariate analysis, factors associated with response to modafinil were higher Epworth Sleepiness Scale score at diagnosis, higher Epworth score while on conventional therapy, and male gender, said Dr. Moralejo, who has no affiliation with Cephalon, maker of Provigil. But on multivariate analysis, a high Epworth score at diagnosis of OSA and increasing age correlated best with response to modafinil.
The average dosage of modafinil was 227.3 mg once daily (range 100–800). No significant side effects were documented.
Epworth Sleepiness Scale scores at the diagnosis of OSA and after treatment with conventional modalities were obtained from the patients' records. A telephone survey was conducted and included questions about patients' demographics, modafinil treatment, and type of ongoing conventional treatment for OSA as well as patient compliance with this treatment.