Venlafaxine With or Without Zolpidem in Treating Hot Flashes and Associated Sleep Disorders in Women With Breast Cancer OR at High Risk for Developing Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •At increased risk of developing breast cancer, meeting 1 of the following criteria:
• •* Diagnosis of 1 of the following:
• •* Ductal carcinoma in situ
• •* Invasive breast cancer
• •* Lobular carcinoma in situ
• •* Atypical ductal or lobular hyperplasia
• •* Lobular carcinoma
• •* Candidate for breast cancer risk reduction for any of the following:
• •* Predisposing mutation in a breast cancer susceptibility gene
• •* Prior chest radiotherapy for Hodgkin's disease
• •* Gail model score \> 1.67% over 5 years
• •Experiencing daytime and nocturnal hot flushes at least 14 times per week within the past 2 weeks
• •Experiencing sleep disturbance, characterized by the presence of all of the following for ≥ 1 month:
• •* ≥ 3 awakenings per night occurring ≥ 3 nights per week
• •* Insomnia impedes daytime function
• •* Hot flushes are the primary cause of insomnia (determined at baseline visit)
• •Hormone receptor status:
• •* Not specified
• •PATIENT CHARACTERISTICS:
• •Age
• •18 to 65
• •Sex
• •Female
• •Menopausal status
• •Not specified
• •Performance status
• •ECOG 0-1
• •Life expectancy
• •At least 6 months
• •Hematopoietic
• •Not specified
• •Hepatic
• •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• •Bilirubin ≤ 1.5 times ULN
• •Renal
• •Creatinine ≤ 1.5 times ULN
• •Cardiovascular
• •No clinically significant cardiac disease
• •No uncontrolled hypertension within the past 3 months, defined as the following:
• •* Diastolic blood pressure \> 95 mm Hg on \> 1 occasion
• •* Systolic blood pressure \> 160 mm Hg on \> 1 occasion
• •Pulmonary
• •No clinically significant respiratory disease
• •Psychiatric
• •Beck depression inventory score ≤ 15
• •No active panic or depressive disorder within the past month
• •No lifetime history of bipolar or psychotic disorder
• •No active substance-use disorders, including alcohol and benzodiazepines, within the past year
• •No suicidal or homicidal ideation
• •No hypomania or mania
• •Other
• •No prior adverse reaction to venlafaxine or zolpidem
• •None of the following sleep disorders within the past 6 months:
• •* Sleep apnea
• •* Narcolepsy
• •* Periodic limb movement disturbance
• •No abuse or misuse of study medication
• •No daytime sedation that interferes with ability to function
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective barrier contraception during and for 1 month after study participation
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •Not specified
• •Chemotherapy
• •More than 3 months since prior chemotherapy
• •No concurrent chemotherapy
• •Endocrine therapy
• •More than 1 month since prior regular use (\> 25% of the time) of oral, transdermal, or injection preparations of androgens, estrogens, or progestins
• •* Vaginal suppositories and creams allowed
• •No concurrent regular use of oral, transdermal, or injection preparations of androgens, estrogens, or progestins
• •Radiotherapy
• •See Disease Characteristics
• •More than 3 months since prior radiotherapy
• •No concurrent radiotherapy
• •Surgery
• •See Disease Characteristics
• •Other
• •More than 1 month since prior regular use (\> 25% of the time) of any of the following:
• •* Hypnotic agents (e.g., benzodiazepines, zolpidem, zaleplon, trazodone, or diphenhydramine)
• •* Clonidine
• •More than 1 month since prior antidepressants or other medications that are known to influence mood \> 25% of the time (no serotonin-reuptake inhibitors \[SRI\] stratum only)
• •Concurrent SRI required provided they were initiated ≥ 1 month ago at or above the minimum dose, including any of the following (concurrent SRI stratum only):
• •* Fluoxetine
• •* Paroxetine
• •* Paroxetine CR
• •* Sertraline
• •* Citalopram
• •* S-citalopram
• •* Venlafaxine
• •* Fluvoxamine
• •No concurrent warfarin
• •No concurrent hypnotic agents, clonidine, or antidepressants, or other medications known to influence sleep, or mood