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