TheraRadar
Data updated: Jun 28, 2026

ZOLPIDEM TARTRATE · Sun Pharma

Generic · see AMBIEN CR
Sleep Approved 1992-12-16

ZOLPIDEM TARTRATE is FDA-approved to treat 1 condition (same as AMBIEN CR).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
25
Indications
--
Phase 3 Trials
33
Years on Market

Details

Status
Prescription
First Approved
1992-12-16
Routes
ORAL, SUBLINGUAL
Dosage Forms
TABLET, TABLET, EXTENDED RELEASE, CAPSULE

Companies

Sun Pharma PH HEALTH STRIDES PHARMA Apotex NOVEL LABS INC SYNTHON PHARMS WATSON LABS INC Viatris Teva RISING YUNG SHIN PHARM Hikma Aurobindo Pharma WOCKHARDT LTD BRECKENRIDGE ACME LABS CHARTWELL MOLECULAR TORRENT PHARMS Lupin Novartis INVAGEN PHARMS PHARMOBEDIENT STRIDES PHARMA INTL ALMATICA UMEDICA LABS PVT SENORES PHARMS Dr. Reddy's
Active Ingredient: ZOLPIDEM TARTRATE

ZOLPIDEM TARTRATE Approval History

2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
398 FDA actions from 2007 to 2026
May 2026 ORIGINAL
Update
Jan 2025 SUPPL
Label · Labeling
Dec 2024 SUPPL
Label · Labeling

What ZOLPIDEM TARTRATE Treats

1 indications

ZOLPIDEM TARTRATE is approved for 1 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as AMBIEN CR (same active ingredient).

Source: FDA Label

Sun Pharma's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

LEQSELVI
2024
DEURUXOLITINIB PHOSPHATE
1 designation
WINLEVI
2020
CLASCOTERONE
1 designation
📋

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

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.

ZOLPIDEM TARTRATE FDA Label Details

Indications & Usage

FDA Label (PDF)

ZOLPIDEM TARTRATE is FDA-approved to treat 1 condition — same approved indications as AMBIEN CR.

Looking for the branded version?

AMBIEN CR

Full clinical data, patents, trials, and competitive landscape for zolpidem tartrate.

See AMBIEN CR

Data Sources

FDA Approval: ANDA078055 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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