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).