The effects of modafinil and cognitive behavior therapy on sleep continuity in patients with primary insomnia.

Background: Daytime fatigue, if not frank sleepiness, is a common symptom among patients with insomnia, one that is exacerbated during acute treatment with cognitive behavior therapy (CBT). The present study was undertaken to assess whether modafinil could be used to reduce daytime fatigue, sleepiness, or both in patients with primary insomnia and whether the pharmacologic augmentation of wakefulness might produce improved sleep by itself or in combination with CBT.

Methods: 30 subjects with primary insomnia were enrolled in this study and were randomly assigned to 1 of 3 treatment conditions: (1) placebo plus CBT, (2) 100 mg modafinil plus CBT, or (3) 100 mg modafinil plus a contact control (monitor-only condition). Subjects were continuously monitored with sleep diaries from study intake until study end (10 weeks) and were evaluated on a weekly basis for changes in sleepiness.

Results: The mean age of the group was 41.3 years (SD, 13.4), and 70.4% of subjects were women. All 3 groups exhibited mean sleep latency and wake after sleep-onset times that were more than 30 minutes in duration. The mean pretreatment sleep profiles did not significantly differ. Modafinil, when administered alone, did not significantly affect the patients' sleep profiles. A trend, however, was evident for improved sleep latency. Modafinil, as an adjunct to CBT, tended to (1) reduce daytime sleepiness as measured by the Epworth Sleepiness Scale and (2) enhance compliance with CBT. With respect to the latter, subjects in the modafinil plus CBT group more reliably adhered to the prescribed phase delay in bedtime than did the placebo plus CBT group.

Discussion: These data suggest that modafinil may be used to diminish the negative side effects of CBT (increased daytime sleepiness) and may increase subject compliance with therapy. Whether enhanced daytime function mediates the change in adherence and whether reduced sleepiness and enhanced compliance translate to less patient attrition in the clinical setting remain to be evaluated.