TheraRadar
Data updated: May 26, 2026

SONATA (zaleplon)

Trial Activity: Declining
Sleep Approved 1999-08-13
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

University of Pennsylvania conducting 1 trials (33%)
9 indications explored (Moderate)
→ hiv/aids (1 trials)
→ clinical depression (1 trials)
→ dementia (1 trials)
2
Indications
--
Phase 3 Trials
26
Years on Market

Details

Status
Discontinued
First Approved
1999-08-13
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Pfizer
Active Ingredient: ZALEPLON

SONATA Approval History

2000
2001
2002
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2008
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Original
New Indication
New Form
Label Update
26 FDA actions from 1999 to 2019 · 1 indication expansions
Aug 2019 SUPPL
Label · Labeling
FDA Letter Label
Feb 2019 SUPPL
Label · Labeling
FDA Letter Label
Apr 2013 SUPPL
Label · Labeling
FDA Letter Label

What SONATA Treats

2 FDA approvals

Originally approved for its first indication in 1999 . Covers 2 distinct patient populations.

  • Other (2)
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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
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

SONATA FDA Label Details

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Data Sources

FDA Approval: NDA020859 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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