AMBIEN (zolpidem tartrate)
Ambien is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. It is specifically used to decrease sleep latency, with clinical efficacy demonstrated for treatment durations of up to 4–5 weeks.
How AMBIEN Works
Zolpidem functions as a GABA A receptor positive modulator. It binds to the benzodiazepine site of GABA A receptors specifically containing the α1 subunit. This binding increases the frequency of chloride channel opening, leading to hyperpolarization of the neuron and the inhibition of neuronal excitation, which facilitates the onset of sleep.
Details
- Status
- Prescription
- First Approved
- 1992-12-16
- Routes
- ORAL
- Dosage Forms
- TABLET
AMBIEN Approval History
What AMBIEN Treats
1 indicationsAMBIEN is approved for 1 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Insomnia
AMBIEN 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. Some of these events may result in serious injuries, including death. Discontinue AMBIEN 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 slee...
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. Some of these events may result in serious injuries, including death. Discontinue AMBIEN 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. Some of these events may result in serious injuries, including death. Discontinue AMBIEN immediately if a patient experiences a complex sleep behavior. ( 4 , 5.1 )
AMBIEN 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
3 of 17FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 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 |
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 FDA Label Details
Indications & Usage
FDA Label (PDF)AMBIEN 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. Some of these events may result in serious injuries, including death. Discontinue AMBIEN immediately if a patient...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.