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