INTERMEZZO (zolpidem tartrate)
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2011-11-23
- Patent Cliff
- 2029
- Routes
- SUBLINGUAL
- Dosage Forms
- TABLET
INTERMEZZO Approval History
What INTERMEZZO Treats
1 FDA approvalsOriginally approved for its first indication in 2011 .
- Other (1)
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.
INTERMEZZO FDA Label Details
Pro Intelligence Preview
Deep insights for INTERMEZZO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 8 active patents
Trial Analysis
- • 3 total trials
- • Stage: Mature
Competitive Landscape
- • Competitor tracking
- • 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment