Ambien CR vs. Placebo For Treatment Of Insomnia Associated With Anxiety When Used Concomitantly With Escitalopram (Lexapro)

Inclusion Criteria

• •1. Male or female between the ages of 21and 64 years, inclusive;
• •2. Women must use a medically acceptable form of contraception 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;
• •3. Must meet the diagnostic requirements of Generalized Anxiety Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders;
• •4. Score at least 18 on the Hamilton Rating Scale for Anxiety (HAM-A)
• •5. Must be either newly diagnosed or show symptoms of relapse during a period of no drug therapy for anxiety.
• •6. Subject must experience sleep disturbances at least three nights per week, for at least one month prior to study entry, based on historical data.
• •7. Subject must be stabilized on all long-term medication therapy for at least one month prior to study entry.
• •EXCLUSION
• •1. History of Post-Traumatic Stress Disorder;
• •2. Concomitant Major Depressive Disorder or Bipolar Disorder;
• •3. Any abnormal pre-study laboratory values that require clinical intervention
• •4. Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous month.
• •5. Pregnant or breastfeeding
• •6. History of drug addiction, alcoholism, or drug abuse
• •7. Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization.
• •8. A positive urine drug screen for compounds that would interfere with the assessment of a hypnotic.
• •9. Use of prescription and non-prescription sedative drugs;
• •10. Prior failure to respond to escitalopram therapy for anxiety
• •11. The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy.
• •12. History of sleep apnea
• •13. History of myasthenia gravis
• •14. Known hypersensitivity and/or allergy to or previous adverse experience with zolpidem or escitalopram or any of their excipients
• •15. Subject is currently participating in another clinical trial (or within 28 days of screening).