Tools / Drug approvals and letters / Drugs Zolpidem Tartrate Treats insomnia characterized. Sold as Ambien, Tovalt Odt, Ambien Cr, Edluar, Zolpimist and 2 more. Every FDA application for this active ingredient: 7 branded and 36 generic.
As of Nov 15, 2026, FDA lists 43 applications for Zolpidem Tartrate (sold as Ambien, Tovalt Odt, Ambien Cr and others), first approved Dec 16, 1992, with 5 new uses approved and 1 published complete response letter.
First approved : Dec 16, 1992 Applications : 43 New uses approved : 5 Complete response letters : 1 Medicare spending, 2025 : $83.7M
Medicare Spending CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name Product Part Spending, 2025 Change Beneficiaries Zolpidem Tartrate Part D $58.1M +16% 1,474,139 Zolpidem Tartrate ER Part D $11.0M +1% 86,356 Ambien Part D $8.9M -14% 2,087 Ambien Cr Part D $4.8M -14% 984 Edluar Part D $822K +11% 274
What Pharmacies Pay Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change ZOLPIDEM TARTRATE 10 MG TABLET: $0.039 per unit Generic · +1% in a year ZOLPIDEM TARTRATE 5 MG TABLET: $0.035 per unit Generic · +1% in a year ZOLPIDEM TARTRATE 7.5 MG CAP: $7.99 per unit Generic · +1% in a year AMBIEN 10 MG TABLET: $22.61 per unit Brand · +10% in a year AMBIEN CR 12.5 MG TABLET: $22.57 per unit Brand · +9% in a year EDLUAR 10 MG SL TABLET: $15.48 per unit Brand · +5% in a year Clinical Trials 13 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all Study Phase Status Posted Psilocybin for Depression in Veterans Major Depression · VA Office of Research and Development Phase 2 Not yet recruiting Oct 26, 2026 Discontinuing Psychotropic Medication Before Psychotherapy for PTSD Post-traumatic Stress Disorder (PTSD) · Academic Centre for Dentistry in Amsterdam — Not yet recruiting Sep 3, 2026 A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia Insomnia, Insomnia Disorder · University of Pennsylvania Phase 4 Recruiting Apr 21, 2026 Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients Orthopedic Trauma, Sleep Quality · Emory University Phase 3 Recruiting Jan 13, 2026 Trazodone on NREM Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients Depressed Insomniac Co-morbid Patients · Tongji University Phase 4 Recruiting Dec 18, 2024 The Study in Outpatient Medicine Using Nudges to Improve Sleep Inappropriate Prescribing · University of Southern California Not applicable Active, not recruiting Oct 15, 2024 Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial Depressive Disorder, Major · Sultan Qaboos University Phase 4 Not yet recruiting Mar 12, 2024 The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion Spine Fusion, Lumbar Spine Degeneration · University of Southern California Phase 4 Recruiting Feb 27, 2023
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Dec 16, 1992 Ambien NDA 19908 · New molecular entity 31 Marketed Sep 2, 2005 Ambien Cr NDA 21774 · New dosage form 18 Marketed Apr 23, 2007 Zolpidem Tartrate ANDA 76062 2 Discontinued Apr 23, 2007 Zolpidem Tartrate ANDA 77214 6 Marketed Apr 23, 2007 Zolpidem Tartrate ANDA 77288 0 Discontinued Apr 23, 2007 Zolpidem Tartrate ANDA 77359 3 Discontinued Apr 23, 2007 Zolpidem Tartrate ANDA 77773 0 Discontinued Apr 23, 2007 Zolpidem Tartrate ANDA 77884 11 Discontinued Apr 23, 2007 Zolpidem Tartrate ANDA 77985 4 Discontinued Apr 23, 2007 Zolpidem Tartrate ANDA 77990 4 Discontinued Apr 23, 2007 Zolpidem Tartrate ANDA 78055 3 Discontinued Apr 23, 2007 Zolpidem Tartrate ANDA 76410 11 Discontinued Apr 23, 2007 Zolpidem Tartrate ANDA 76578 11 Discontinued Apr 23, 2007 Zolpidem Tartrate ANDA 77322 11 Marketed Apr 25, 2007 Tovalt Odt NDA 21412 · New dosage form 0 Discontinued May 4, 2007 Zolpidem Tartrate ANDA 78413 12 Marketed May 15, 2007 Zolpidem Tartrate ANDA 78426 2 Discontinued Aug 17, 2007 Zolpidem Tartrate ANDA 77903 15 Marketed Sep 7, 2007 Zolpidem Tartrate ANDA 78184 4 Discontinued Apr 30, 2008 Zolpidem Tartrate ANDA 78129 3 Discontinued Nov 21, 2008 Zolpidem Tartrate ANDA 78616 7 Discontinued Dec 19, 2008 Zolpimist NDA 22196 · New dosage form 5 Discontinued Mar 13, 2009 Edluar NDA 21997 · New dosage form 7 Marketed Dec 3, 2010 Zolpidem Tartrate ANDA 78148 6 Discontinued Jun 6, 2011 Zolpidem Tartrate ANDA 78179 5 Discontinued Jun 6, 2011 Zolpidem Tartrate ANDA 78483 0 Discontinued Jul 1, 2011 Zolpidem Tartrate ANDA 90107 7 Marketed Nov 23, 2011 Intermezzo NDA 22328 · New dosage form 6 Discontinued Jul 30, 2012 Zolpidem Tartrate ANDA 77388 5 Marketed Mar 25, 2013 Zolpidem Tartrate ANDA 90153 0 Discontinued Sep 10, 2013 Zolpidem Tartrate ANDA 200266 8 Discontinued Sep 11, 2013 Zolpidem Tartrate ANDA 78970 10 Marketed Jun 3, 2015 Zolpidem Tartrate ANDA 204299 2 Marketed Aug 1, 2016 Zolpidem Tartrate ANDA 201509 2 Marketed Aug 8, 2016 Zolpidem Tartrate ANDA 202657 1 Discontinued Nov 18, 2016 Zolpidem Tartrate ANDA 204503 0 Marketed Jan 24, 2017 Zolpidem Tartrate ANDA 204170 5 Marketed Sep 11, 2017 Zolpidem Tartrate ANDA 204229 2 Marketed Jun 4, 2020 Zolpidem Tartrate ANDA 213592 1 Marketed May 9, 2023 Zolpidem Tartrate NDA 215721 · New dosage form 0 Marketed May 12, 2026 Zolpidem Tartrate ANDA 220717 0 Marketed — Zolpidem Tartrate ANDA 77540 0 Discontinued — Zolpidem Tartrate ANDA 78016 0 Discontinued
Complete Response Letters FDA's published letters for these applications Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
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