AMBIEN CR (zolpidem tartrate)
Ambien CR is an extended-release medication used for the short-term management of insomnia. It helps patients who have trouble falling asleep as well as those who struggle to stay asleep during the night. This treatment is prescribed to improve sleep onset and reduce the amount of time spent awake after initially drifting off.
How AMBIEN CR Works
This drug works by binding to the benzodiazepine site of specific GABA A receptors in the brain. This action increases the frequency of chloride channel opening, which inhibits neuronal excitation to help facilitate sleep.
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 )
AMBIEN CR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to AMBIEN CR
3 of 17FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03774810 R01 results posted | 831801 R01AG054521-01A1 | Ph 4 | completed | Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia |
| NCT02783729 SUNRISE 1 results posted | E2006-G000-304 2015-004347-39 | Ph 3 | completed | Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1) |
| NCT03307005 results posted | IRB00142395 | Ph 4 | completed | Improving Sleep Quality in Heart Failure |
| NCT00683436 | NG2-73-205 | Ph 2 | terminated | Efficacy and Safety Study of Adipiplon, Placebo and an Active Control in Primary Insomniacs |
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
Indications & Usage
FDA Label (PDF)AMBIEN CR is indicated for the treatment of Insomnia.
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...
Track AMBIEN CR with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.