AMBIEN CR
Details
- Status
- Prescription
- First Approved
- 2005-09-02
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
AMBIEN CR Approval History
What AMBIEN CR Treats
1 indicationsAMBIEN CR is approved for 1 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Insomnia
AMBIEN CR Boxed Warning
COMPLEX SLEEP BEHAVIORS Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of AMBIEN CR. Some of these events may result in serious injuries, including death. Discontinue AMBIEN CR immediately if a patient experiences a complex sleep behavior [see Contraindications (4) and Warnings and Precautions (5.1) ]. WARNING: COMPLEX SLEEP BEHAVIORS See full prescribing information for complete boxed warning. Comple...
WARNING: COMPLEX SLEEP BEHAVIORS Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of AMBIEN CR. Some of these events may result in serious injuries, including death. Discontinue AMBIEN CR immediately if a patient experiences a complex sleep behavior [see Contraindications (4) and Warnings and Precautions (5.1) ]. WARNING: COMPLEX SLEEP BEHAVIORS See full prescribing information for complete boxed warning. Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of AMBIEN CR. Some of these events may result in serious injuries, including death. Discontinue AMBIEN CR immediately if a patient experiences a complex sleep behavior. ( 4 , 5.1 )
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AMBIEN CR FDA Label Details
ProIndications & Usage
FDA Label (PDF)AMBIEN CR (zolpidem tartrate extended-release tablets) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient reported assessment in adult patients only) in duration [see Clinical Studies ]. AMBIEN CR, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term ...
WARNING: COMPLEX SLEEP BEHAVIORS Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of AMBIEN CR. Some of these events may result in serious injuries, including death. Discontinue AMBIEN CR immediately if a p...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.