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