TheraRadar
Data updated: May 26, 2026

PROSOM (estazolam)

Sleep Approved 1990-12-26
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
35
Years on Market

Details

Status
Discontinued
First Approved
1990-12-26
Routes
ORAL
Dosage Forms
TABLET

Companies

ABBOTT
Active Ingredient: ESTAZOLAM

PROSOM Approval History

1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
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2015
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2018
2019
2020
2021
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2026
Original
New Indication
New Form
Label Update
16 FDA actions from 1990 to 2004
Jun 2004 SUPPL
Label · Labeling
FDA Letter
Jan 2003 SUPPL
Mfg · Manufacturing (CMC)
May 1998 SUPPL
Mfg · Manufacturing (CMC)

What PROSOM Treats

1 FDA approvals

Originally approved for its first indication in 1990 .

  • Other (1)
📋

Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT07306494 HBZY2024-C61-03 Ph 4 not yet recruiting Compound Ciwujia Granules in the Treatment of Insomnia
NCT00956319 STCR-0802-TW Ph 4 completed A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients
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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.

PROSOM FDA Label Details

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Data Sources

FDA Approval: NDA019080 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.