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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00296790
Enrollment
372
Registered
2006-02-27
Start date
2006-02-28
Completion date
2007-02-28
Last updated
2007-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Brief summary

A comparison of Zolpidem Tartrate Extended-Release (Ambien CR)vs. Placebo in the Treatment of Insomnia Associated with Generalized Anxiety Disorder (GAD) when Used Concomitantly with Escitalopram (Lexapro - antidepressant).

Interventions

Sponsors

Sanofi
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Evaluate safety and hypnotic efficacy of zolpidem tartrate extended release vs. placebo in treatment of insomnia associated with Generalized Anxiety Disorder when used concomitantly with escitalopram

Secondary

MeasureTime frame
To show that treating insomnia from beginning of SSRI (Selective Serotonin Reuptake Inhibitor) treatment for anxiety results in improvement in quality of life and possibly greater response to anti-anxiety therapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026