TheraRadar
Data updated: May 26, 2026

TOVALT ODT (zolpidem tartrate)

Sleep Approved 2007-04-25
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
19
Years on Market

Details

Status
Discontinued
First Approved
2007-04-25
Routes
ORAL
Dosage Forms
TABLET, ORALLY DISINTEGRATING

Companies

BIOVAIL LABS INTL
Active Ingredient: ZOLPIDEM TARTRATE

TOVALT ODT 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
2 FDA actions from 2007 to 2007
Apr 2007 ORIGINAL
New Form · Type 3 - New Dosage Form
FDA Letter Label

What TOVALT ODT Treats

1 FDA approvals

Originally approved for its first indication in 2007 .

  • Other (1)
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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
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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.

TOVALT ODT FDA Label Details

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Data Sources

FDA Approval: NDA021412 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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