Treating Chronic Insomnia in Breast Cancer Patients

Inclusion Criteria:

• Female patients aged 21-60 years old
• Have a negative serum or urine pregnancy test for women of child-bearing potential
• Have a three-month or longer history of insomnia
• Self-report < 6.5 hours of total sleep time, in addition to a sleep efficiency of less than 85%, averaged over two weeks of screening
• A score of less than 60 on the Zung Self-Rating Depression Scale
• Self-report bedtimes that do not vary by more than two hours on five nights per week
• Have completed chemotherapy for breast cancer less than two years prior to study drug administration
• Have completed chemotherapy for breast cancer for at least two months prior to screening visit
• Patients that are receiving Herceptin are eligible for study enrollment
• Have completed radiation therapy for breast cancer for at least two months prior to screening visit
• ECOG (Eastern Cooperative Oncology Group)score of 0-1
• Be able to read, understand, and provide written informed consent before enrolling in the study
• Must be willing to comply with all study visits and comply with daily phone calls to the IVRS throughout the study
• Agree to participate for the entire study period (about two months)

Exclusion Criteria:

• Metastatic disease
• Pregnant or lactating female
• Self-reports typical consumption of more than five alcoholic beverages on a single day or greater than 14 alcoholic beverages weekly
• Self-reports use of products containing nicotine of greater than 15 cigarettes daily or cannot avoid products containing nicotine during sleep periods
• Current use of any of the following medications, and cannot discontinue these medications for the duration of the study: Hypnotic medication, Anti-convulsants, Anxiolytics, Narcotic analgesics, Medications or supplements containing Melatonin, Ketaconazole and Fluconazole
• Currently taking fluvoxamine, brand name Luvox
• Have symptoms consistent with the diagnosis of any other sleep disorder other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless legs syndrome)
• Currently on night or rotating shift work
• Self-reports habitual napping of greater than one hour accumulated sleep on 4 or more days per week
• Has a psychiatric illness that interferes with normal sleep-wake function (e.g. major depression, post-traumatic stress disorder)
• A score of 60 or greater on the Zung Self-Rating Depression Scale
• Has current unstable medical disorder, such as symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, or other serious medical condition as determined by the Investigator