ZALEPLON
ZALEPLON is indicated for the treatment of Insomnia.
Details
- Status
- Discontinued
- First Approved
- 2008-06-06
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
ZALEPLON Approval History
What ZALEPLON Treats
1 indicationsZALEPLON is approved for 1 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Insomnia
ZALEPLON 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 zaleplon. Some of these events may result in serious injuries, including death. Discontinue zaleplon immediately if a patient experiences a complex sleep behavior (see CONTRAINDICATIONS and Complex Sleep Behaviors under WARNINGS)....
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 zaleplon. Some of these events may result in serious injuries, including death. Discontinue zaleplon immediately if a patient experiences a complex sleep behavior (see CONTRAINDICATIONS and Complex Sleep Behaviors under WARNINGS).
ZALEPLON Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 ZALEPLON
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 |
|---|---|---|---|---|
| NCT03489304 results posted | 819083 | Ph 2 | completed | Zaleplon in HIV Patients With Depression |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT01159652 | 63-SR-10 | Ph 4 | completed | Hypnotic Medications and Memory: Effect of Drug Exposure During the Night |
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.
ZALEPLON FDA Label Details
Indications & Usage
FDA Label (PDF)ZALEPLON 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 zaleplon. Some of these events may result in serious injuries, including death. Discontinue zaleplon immediately if a pat...
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Full clinical data, patents, trials, and competitive landscape for zaleplon.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.