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