EDLUAR (zolpidem tartrate)
Edluar is a sublingual formulation of zolpidem tartrate indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Clinical efficacy has been demonstrated in reducing sleep latency for durations of up to 35 days.
How EDLUAR Works
Zolpidem functions as a GABA A receptor positive modulator. It binds selectively to the benzodiazepine site of $\alpha_1$ subunit-containing GABA A receptors. This binding increases the frequency of chloride channel opening, which enhances GABA-mediated inhibitory neurotransmission and results in the inhibition of neuronal excitation.
Details
- Status
- Prescription
- First Approved
- 2009-03-13
- Patent Cliff
- 2031
- Routes
- SUBLINGUAL
- Dosage Forms
- TABLET
EDLUAR Approval History
What EDLUAR Treats
1 indicationsEDLUAR is approved for 1 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Insomnia
EDLUAR 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 Edluar. Some of these events may result in serious injuries, including death. Discontinue Edluar 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 Edluar. Some of these events may result in serious injuries, including death. Discontinue Edluar 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 Edluar. Some of these events may result in serious injuries, including death. Discontinue Edluar immediately if a patient experiences a complex sleep behavior. ( 4 , 5.1 )
EDLUAR Competitive Set
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MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 EDLUAR
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.
EDLUAR FDA Label Details
Indications & Usage
FDA Label (PDF)EDLUAR 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 Edluar. Some of these events may result in serious injuries, including death. Discontinue Edluar immediately if a patient...
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Deep insights for EDLUAR
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 8 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 17 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.