Phase IV: Treatment of Chronic Insomnia in Patients With Breast Cancer Following Completion of Chemotherapy

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