Ambien CR For Treatment Of Insomnia Associated With Depression When Used Concomitantly With Lexapro

MAJOR INCLUSION CRITERIA:

• Must experience sleep disturbances at least 3 nights/week, based on historical data
• Must meet the diagnostic requirements for Major Depressive Disorder
• Must have QIDS-SR16 score between 6 and 15
• Must be either newly diagnosed or show symptoms of relapse/recurrence of depression while not on medication
• Age 21-64, inclusive
• Women must use a medically acceptable form of contraception (steroidal contraceptive, double-barrier, or intra-uterine device) during the entire study period, or: be surgically sterilized, post-menopausal, agree to use double-barrier contraception throughout the study period, or must have a negative urine pregnancy test prior to randomization.
• Subject must be stabilized on all ongoing long-term medication therapy for at least 28 days prior to screening visit.

MAJOR EXCLUSION CRITERIA:

• Severity of depressive episode had been rated as "severe" or "severe with psychotic features."
• History of a suicide attempt or suicidal ideation.
• History of mania, manic episode or bipolar disease.
• Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization.
• Use of prescription and non-prescription sedative drugs given for the purpose of sleep induction or to relieve jet lag
• Any abnormal pre-study laboratory values that require clinical intervention
• Prior failure to respond to escitalopram therapy for depression
• Current depressive episode requiring inpatient hospitalization.
• Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous 28 days.
• History of drug addiction, alcoholism, or drug abuse.
• A positive urine drug screen for medication that would interfere with the assessment of the study medication.
• Known allergy to zolpidem, escitalopram or any of their excipients
• History of sleep apnea
• History of myasthenia gravis
• The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy.
• Pregnant or breastfeeding
• Subject is participating in another clinical trial, or has completed another clinical trial within 28 days prior to screening.