Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study

Inclusion Criteria:

- Be scheduled for planned cancer treatment with chemotherapy or biologics, such as
Herceptin (prior chemotherapy and diagnosis of metastatic breast are allowed)

- Have at least 6 weeks of treatment remaining

- Be at least 21 years old

- Be able to swallow medication

- Exhibit onset or worsening of problems falling or staying asleep

Exclusion Criteria:

- Have ever taken armodafinil or modafinil

- Have an unstable medical or psychiatric illness (Axis I - current or within the last
5 years)

- Have a history of or uncontrolled cardiac disease, hypertension, severe headaches,
glaucoma, or seizures

- Have taken a psycho-stimulant medication within the past 28 days

- Be currently pregnant or nursing

- Have a history of substance abuse or meet criteria for current alcohol abuse or
dependence

- Have a self-reported history of chronic, preexisting insomnia, sleep apnea, or RLS
syndrome

- Have taken sleep medication daily for the last 28 days continuously

- Have severe hepatic impairment

- Be taking anti-seizure medications