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

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