Drugs / Zolpidem
Zolpidem
also known as
Zolpidem Tartrate · Ambien · Ambien CR · ZOL · SL800750 · Stilnox · Zolpidem CR · Myslee · +7 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | AMBIEN CR | — | 2007-12-20 | fda.gov ↗ |
| Label expansion | US (FDA) | AMBIEN | — | 2007-03-28 | fda.gov ↗ |
| Approved | US (FDA) | AMBIEN | — | 1992-12-16 | fda.gov ↗ |
Trials 92 · started per year
today
US approved 1992
2
3
3
4
3
12
4
4
5
4
2
2
2
1
4
5
10
3
2
1
2
2
4
3
1
2
1992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT01747590 | Jul 2011 → Dec 2013 | drug-induced mental disorder | Mclean Hospital | Unknown | No outcome recorded |
| Phase 0 | NCT01809626 | May 2010 → Sep 2012 | depressive disorder | Mclean Hospital | Completed | No outcome recorded |
| Phase 117 trials · 1 met primary · 1 missed | ||||||
| Phase 1 | NCT06512155 | Jul → Nov 2024 | sleep disorder | Mengchang Yang | Completed | No outcome recorded |
| Phase 1 | NCT05106153 | Dec 2021 → May 2023 | substance abuse | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03436745 | Jan 2019 → Jan 2024 | prostate cancer | National Cancer Institute (NCI) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03269760 | Sep 2017 → Feb 2020 | sleep disorder | University of California, San Francisco | Completed | No outcome recorded |
| Phase 1 | NCT02817750 | Jul 2017 → Feb 2018 | — | Biolab Sanus Farmaceutica | Completed | No outcome recorded |
| Phase 1 | NCT02814058 | Jul 2017 → Feb 2018 | — | Biolab Sanus Farmaceutica | Completed | No outcome recorded |
| Phase 1 | NCT03158025 | Apr 2017 → Jul 2018 | insomnia | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03008447 | Nov 2016 → Jan 2018 | — | Eisai Inc. | Completed | Met primary |
| Phase 1 | NCT02607696 | May → Oct 2016 | — | Biolab Sanus Farmaceutica | Withdrawn | No outcome recorded |
| Phase 1 | NCT02578472 | Nov 2015 → Feb 2016 | — | Janssen-Cilag International NV | Completed | No outcome recorded |
| Phase 1 | NCT01463098 | Oct 2011 → Aug 2012 | insomnia | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01106859 | Jun → Sep 2010 | insomnia | Transcept Pharmaceuticals | Completed | Missed primary |
| Phase 1 | NCT01987739 | Sep 2009 → Feb 2010 | — | Midnight Pharma, LLC | Completed | No outcome recorded |
| Phase 1 | NCT00893269 | Oct 2008 → Oct 2010 | cannabis dependence | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT00716521 | Jul → Oct 2008 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00440323 | Jan → Jul 2007 | sleep disorder, initiating and maintaining sleep | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00833937 | Mar 2002 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05351541 | Dec 2023 → Jul 2026 overdue | chronic pain syndrome | Joshua Woolley, MD, PhD | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT00494468 | Oct 2002 → Mar 2004 | insomnia | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| Phase 211 trials · 1 met primary | ||||||
| Phase 2 | NCT05540574 | Aug 2023 → Apr 2028 expected | autism | Stanford University | Recruiting | No outcome recorded |
| Phase 2 | NCT04396327 | May → Jun 2020 overdue | insomnia | Sequential Medicine Ltd | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT03621046 | Aug 2018 → Dec 2019 | Parkinson disease | Aston University | Completed | No outcome recorded |
| Phase 2 | NCT02948660 | Dec 2017 → Jun 2019 | cognitive disorder | Xijing Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03375203 | Nov 2017 → Apr 2019 | insomnia | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2 | NCT03056053 | Feb → Apr 2017 | insomnia | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02671760 | Feb → Jun 2016 | insomnia | Sequential Medicine Ltd | Completed | No outcome recorded |
| Phase 2 | NCT00539110 | Dec 2009 → Dec 2012 | — | Shriners Hospitals for Children | Completed | No outcome recorded |
| Phase 2 | NCT00784875 | Oct 2008 → Feb 2010 | insomnia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00044629 | Sep 2001 → Aug 2006 | sleep disorder, initiating and maintaining sleep | Duke University | Completed | No outcome recorded |
| Phase 2 | NCT01351168 | — | Parkinson disease | Rush University Medical Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT03885141 | Mar → Dec 2021 | insomnia | Biolab Sanus Farmaceutica | Unknown | No outcome recorded |
| Phase 2/3 | NCT01685073 | Sep 2012 → Jul 2018 | drug dependence | Johns Hopkins University | Completed | No outcome recorded |
| Phase 315 trials · 2 met primary · 2 missed | ||||||
| Phase 3 | NCT07336277 | Jun → Jul 2026 overdue | sleep disorder | Emory University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05456152 | Jun 2024 → Jan 2025 | insomnia | EMS | Unknown | No outcome recorded |
| Phase 3 | NCT03338764 | May → Dec 2023 | insomnia | Sequential Medicine Ltd | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03331042 | Oct 2017 → Mar 2018 | insomnia | Sequential Medicine Ltd | Completed | No outcome recorded |
| Phase 3 | NCT03075241 | Oct 2016 → Apr 2020 | Alzheimer disease, insomnia | Brasilia University Hospital | Completed | Missed primary |
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT02139098 | May 2014 → Nov 2017 | insomnia | Philipps University Marburg | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00466193 | May → Nov 2007 | insomnia | Transcept Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00374777 | Aug 2006 → May 2008 | sleep disorder, initiating and maintaining sleep | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00318448 | Apr → Aug 2006 | attention deficit-hyperactivity disorder | Sanofi | Completed | Missed primary |
| Phase 3 | NCT00380081 | Apr → Jul 2006 | insomnia | Transcept Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00999219 | Mar 2006 → Jul 2007 | sleep disorder, initiating and maintaining sleep | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00283946 | Feb 2006 → Nov 2007 | sleep disorder, initiating and maintaining sleep | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00425243 | Aug 2004 → Jan 2006 | sleep disorder, initiating and maintaining sleep | Sanofi | Completed | Met primary |
| Phase 3 | NCT00630175 | Sep 2003 → Feb 2004 | sleep disorder, initiating and maintaining sleep | Sanofi | Completed | No outcome recorded |
| Phase 433 trials · 1 met primary · 2 missed | ||||||
| Phase 4 | NCT07542756 | May 2026 → Jan 2032 expected | insomnia | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 4 | NCT07801742 | Aug 2025 → Jun 2026 | — | Sanatorio Allende | Completed | No outcome recorded |
| Phase 4 | NCT06800378 | Jun → Dec 2024 | — | National Taiwan Normal University | Completed | No outcome recorded |
| Phase 4 | NCT06084130 | Oct 2023 → Oct 2024 | obstructive sleep apnea syndrome | Siriraj Hospital | Unknown | Missed primary |
| Phase 4 | NCT04468776 | Feb 2022 → Jun 2024 | insomnia | California Pacific Medical Center Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT05746143 | Feb 2022 → Jan 2029 expected | lumbar disk degenerative disorder, spondylosis | University of Southern California | Recruiting | No outcome recorded |
| Phase 4 | NCT03774810 | Apr 2019 → Sep 2024 | insomnia | University of Pennsylvania | Completed | No outcome recorded |
| Phase 4 | NCT03657212 | Oct 2018 → Jan 2019 | premature aging syndrome | University of California, Irvine | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT04720547 | Jul 2018 → Feb 2020 | sleep apnea syndrome | Wayne State University | Completed | No outcome recorded |
| Phase 4 | NCT03307005 | Nov 2017 → Jan 2019 | heart failure, sleep disorder | Johns Hopkins University | Completed | No outcome recorded |
| Phase 4 | NCT03297944 | Sep 2017 → Oct 2018 | — | Marion Coe | Completed | No outcome recorded |
| Phase 4 | NCT01920334 | Jul → Oct 2013 | acute coronary syndrome | Associação Fundo de Incentivo à Pesquisa | Unknown | No outcome recorded |
| Phase 4 | NCT01896336 | Feb → Nov 2013 | insomnia | EMS | Completed | No outcome recorded |
| Phase 4 | NCT01159652 | Oct 2010 → May 2011 | — | St. Luke's Hospital, Chesterfield, Missouri | Completed | No outcome recorded |
| Phase 4 | NCT01097382 | Mar 2010 → Apr 2011 | sleep disorder | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT01181232 | Oct 2009 → Apr 2011 | insomnia, sleep disorder, initiating and maintaining sleep | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT00956319 | May 2009 → Nov 2010 | insomnia, sleep disorder, initiating and maintaining sleep | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT00492232 | Apr 2007 → Mar 2008 | insomnia | Takeda | Completed | Missed primary |
| Phase 4 | NCT00432198 | Feb 2007 → Jan 2010 | insomnia | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT00653562 | Nov 2006 → Mar 2010 | insomnia, sleep disorder, initiating and maintaining sleep | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT00359229 | Jul 2006 → Sep 2007 | insomnia | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00568789 | Jun → Sep 2006 | insomnia | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT00296790 | Feb 2006 → Feb 2007 | insomnia | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00296179 | Feb 2006 → Jun 2007 | insomnia | Sanofi | Completed | Met primary |
| Phase 4 | NCT00283790 | Jan → Apr 2006 | insomnia | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00156533 | Mar 2005 → Feb 2008 | insomnia | University of Rochester | Completed | No outcome recorded |
| Phase 4 | NCT00292734 | Jan 2005 → Jun 2006 | depressive disorder, sleep disorder, initiating and maintaining sleep | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00286936 | Feb 2004 → Jan 2007 | delirium | Hvidovre University Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT00227942 | Aug 2003 → Nov 2007 | depressive disorder, sleep disorder, initiating and maintaining sleep | Hadine Joffe, MD | Completed | No outcome recorded |
| Phase 4 | NCT00530556 | Mar 2003 → Jun 2004 | sleep disorder | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00177216 | Feb 2002 → May 2008 | sleep disorder | University of Pittsburgh | Completed | No outcome recorded |
| Phase 4 | NCT00042146 | Dec 2001 → ? | sleep disorder, initiating and maintaining sleep | Laval University | Completed | No outcome recorded |
| Phase 4 | NCT00781482 | — | — | Kettering Health Network | Withdrawn | No outcome recorded |
| Phase not applicable10 trials · 1 missed | ||||||
| — | NCT02778659 | May 2016 → Oct 2017 | — | Centre d'Expertise sur l'Altitude EXALT | Completed | No outcome recorded |
| — | NCT02484963 | May 2015 → Jan 2017 | cirrhosis of liver | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
| — | NCT01485393 | Jan 2015 → Jan 2018 | insomnia | Massachusetts General Hospital | Completed | No outcome recorded |
| — | NCT01551485 | Feb → Aug 2012 | — | Rigshospitalet, Denmark | Unknown | Missed primary |
| — | NCT00936598 | Jul 2009 → Apr 2011 | endometrium neoplasm | University of Pittsburgh | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00777829 | Sep 2008 → Jun 2011 | — | University of California, San Diego | Completed | No outcome recorded |
| — | NCT00662155 | Jul 2006 → Jun 2013 | insomnia | University of Pennsylvania | Completed | No outcome recorded |
| — | NCT00676026 | May 2005 → Feb 2009 | — | University of Pennsylvania | Completed | No outcome recorded |
| — | NCT00383357 | Aug 2004 → ? | — | National Institute on Aging (NIA) | Completed | No outcome recorded |
| — | NCT00084669 | May 2004 → Oct 2007 | breast cancer, sleep disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Comparator or background therapy37 trials | ||||||
| Phase 0 | NCT04273776 Comparator | Dec 2019 → Nov 2024 overdue | — | Walter Reed Army Institute of Research (WRAIR) | Active not recruiting | No outcome recorded |
| Phase 0 | NCT04102345 Comparator | Sep 2019 → Nov 2020 | — | HealthPartners Institute | Completed | No outcome recorded |
| Phase 0 | NCT03160404 Comparator | Apr 2018 → Dec 2019 | insomnia | Federal University of Goiás | Completed | No outcome recorded |
| Phase 1 | NCT05764798 Comparator | Nov 2022 → Dec 2024 | insomnia | Nanfang Hospital, Southern Medical University | Unknown | Missed primary |
| Phase 1 | NCT06685341 Comparator | Mar → Apr 2019 | insomnia | Shanghai Haiyan Pharmaceutical Technology Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03657355 Comparator | Sep 2018 → Aug 2019 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04692285 Comparator | Sep 2017 → Apr 2021 | focal dystonia | University Medical Centre Ljubljana | Completed | No outcome recorded |
| Phase 1 | NCT02033707 Background | Apr 2014 → Feb 2019 | — | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT00976105 Comparator | Sep 2009 → Mar 2010 | obesity disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00940550 Comparator | Jul → Aug 2009 | insomnia | University of Surrey | Completed | No outcome recorded |
| Phase 1 | NCT00828659 Comparator | Dec 2008 → Apr 2009 | substance abuse | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01779830 Comparator | May → Nov 2008 | insomnia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT00833521 Comparator | Feb 2002 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 2 | NCT06095258 Comparator | Dec 2023 → Nov 2025 | long COVID-19 | Chinese University of Hong Kong | Unknown | No outcome recorded |
| Phase 2 | NCT02839200 Comparator | Oct 2016 → Apr 2017 | insomnia | Idorsia Pharmaceuticals Ltd. | Completed | Met primary |
| Phase 2 | NCT00383643 Comparator | May 2006 → Dec 2009 | sleep disorder, initiating and maintaining sleep | Stanford University | Completed | No outcome recorded |
| Phase 2/3 | NCT01804036 Comparator | Mar 2013 → Nov 2016 | insomnia | University of Utah | Completed | No outcome recorded |
| Phase 2/3 | NCT00770510 Comparator | Sep 2008 → May 2010 | insomnia | Eisai Inc. | Completed | Met primary |
| Phase 3 | NCT06975514 Comparator | Mar → Jul 2025 | insomnia | Shanghai Haiyan Pharmaceutical Technology Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05615727 Comparator | Sep 2022 → Sep 2023 | insomnia | The University of Hong Kong | Unknown | No outcome recorded |
| Phase 3 | NCT02783729 Comparator | May 2016 → Jan 2018 | insomnia | Eisai Inc. | Completed | Met primary |
| Phase 3 | NCT02096900 Comparator | Jul 2014 → May 2016 | anxiety | Loma Linda University | Completed | No outcome recorded |
| Phase 3 | NCT00608985 Comparator | Mar 2008 → Sep 2009 | insomnia | Midnight Pharma, LLC | Completed | Met primary |
| Phase 4 | NCT06740188 Comparator | Jan 2025 → Dec 2026 expected | — | Tongji University | Recruiting | No outcome recorded |
| Phase 4 | NCT06303076 Comparator | Sep 2024 → Sep 2026 overdue | major depressive disorder | Sultan Qaboos University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04118387 Comparator | Jan 2021 → Dec 2026 expected | central sleep apnea syndrome | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 4 | NCT04014387 Comparator | Jun 2019 → Jun 2025 | insomnia, progressive supranuclear palsy | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT02456532 Comparator | Aug 2015 → Feb 2022 | insomnia | Henry Ford Health System | Completed | No outcome recorded |
| Phase 4 | NCT02353299 Comparator | Jan 2015 → Jan 2016 | — | Currax Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01689909 Comparator | Dec 2012 → Jun 2017 | depressive disorder, insomnia | Augusta University | Completed | No outcome recorded |
| Phase 4 | NCT03526575 Comparator | Jan 2011 → Jul 2015 | — | National Aeronautics and Space Administration (NASA) | Completed | No outcome recorded |
| Phase 4 | NCT01280734 Comparator | Jan → Apr 2011 | — | Neurim Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT00086281 Comparator | Nov 2003 → Jun 2005 | obstructive sleep apnea syndrome | Jazz Pharmaceuticals | Completed | Met primary |
| — | NCT06244277 Comparator | Dec 2023 → Dec 2025 | sleep disorder | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| — | NCT01651442 Comparator | Aug 2012 → Mar 2017 | insomnia | Jack Edinger, PhD | Completed | No outcome recorded |
| — | NCT01243060 Comparator | May 2011 → Jul 2014 | — | Northern California Institute of Research and Education | Completed | No outcome recorded |
| — | NCT00814502 Comparator | Dec 2008 → Dec 2013 | Alzheimer disease, circadian rhythm sleep disorder, vascular dementia | Massachusetts General Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2025-09-08 | Idorsia Pharmaceuticals Ltd. | Results Idorsia highlights very low real-world abuse potential of DORA class for insomnia treatment at WSC 2025 idorsia.com ↗
The DORA class had significantly lower odds of reporting for adverse events denoting drug abuse when compared with the scheduled drug zolpidem and the non-scheduled drug trazodone, both used as a reference. |
| 2019-08-05 | Aytu BioPharma, Inc. | Results Aytu BioScience Announces First ZolpiMist(TM) Clinical Study Results Demonstrating More Rapid Sleep Onset with Lingual Spray Zolpidem versus Oral Tablet aytubio.com ↗
On average, ZolpiMist achieved this threshold more quickly than tablet zolpidem. |
| 2018-06-06 | Eisai Inc. | Results Positive New Data on Investigational Lemborexant Presented at 32nd Annual SLEEP Meeting Studies measured postural stability after middle-of-the-night awakening and next morning compared to zolpidem ER, as well as next-morning driving performance eisai.com ↗
Zolpidem ER increased body sway at a magnitude almost three times greater than the increase in body sway associated with a blood alcohol content (BAC 0.05 percent) near the legal driving limit. |
| 2018-05-23 | Eisai Inc. | Results EISAI AND PURDUE PHARMA TO PRESENT LATEST PHASE I CLINICAL DATA ON LEMBOREXANT AT 32ND ANNUAL SLEEP MEETING eisai.com ↗
The study demonstrated that postural stability was statistically significantly worse for zolpidem ER 6.25 mg compared with both lemborexant 5 mg and 10 mg in healthy volunteers age 55 and older, and the primary endpoint was achieved. |
| 2012-02-20 | Sumitomo Pharma America, Inc. | Regulatory Dainippon Sumitomo Pharma obtains manufacturing and marketing approval for Sleep Inducing Treatment "Zolpidem tartrate tablets 5mg/10mg [DSP]" sumitomo-pharma.com ↗
Dainippon Sumitomo Pharma Co., Ltd. (DSP) (Headquarters: Osaka, Japan; President: Masayo Tada) announces that as of February 15, 2012, DSP has obtained manufacturing and marketing approval for the sleep inducing treatment "Zolpidem tartrate tablets 5mg/10mg [DSP]" in Japan from the Ministry of Health, Labour and Welfare. |
| 2008-07-29 | Orexo AB | Regulatory The FDA has accepted for filing the registration application for Sublinox™ orexo.com ↗
The submitted registration application for SublinoxTM (OX22) has been accepted by the FDA as complete for substantive review after initial evaluation. |
| 2008-05-15 | Orexo AB | Regulatory Orexo has submitted the registration application (NDA) for Sublinox™ (OX22) to the FDA on May 14 2008 orexo.com ↗ |
| 2007-10-01 | Orexo AB | Results Orexo shows positive results in completed comparative Phase III profile study of the Sublinox™ sleep aid involving insomnia patients orexo.com ↗
The study shows that Sublinox™ (OX22) acts 30 percent faster than Ambien® as a sleep aid for patients suffering from sleep disturbances. |
| 2005-05-29 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval Of Zolpidem Tartrate Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Zolpidem Tartrate Tablets, 5 mg and 10 mg. |
All press releases naming this drug 13 releases
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 135 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Zolpidem | “This is a randomised, double-blind, 3-way crossover, single dose, placebo-controlled study investigating the effect on night time awakening body sway of melatonin and zolpidem...” NCT01280734 ↗125“Patients were randomized 1:1:1:1 to receive placebo, almorexant 100 mg, almorexant 200 mg, or zolpidem 10 mg (active reference) for 16 days.” PMID 28735928 ↗ May 2017 “3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.” NCT03331042 ↗ “single oral doses of lorcaserin (20, 40, and 60 mg), zolpidem (15 and 30 mg), ketamine (100 mg), and placebo was conducted” PMID 21412231 ↗ Mar 2011 “Sedatives/anxiolytics: alprazolam, diazepam, lorazepam, secobarbital, temazepam, triazolam, zolpidem” NCT02033707 ↗ “3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam” NCT02671760 ↗ “3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam” NCT04396327 ↗ “SM-1 is a combination drug product containing diphenhydramine, zolpidem and lorazepam.” NCT03338764 ↗ “Sublingual zolpidem - 1 sublingual tablet 30 minutes before bed time.” NCT05456152 ↗ “Differential Effects of Zolpidem Versus Ramelteon in Burned Children” NCT00539110 ↗ “containing 1.0 mg, 1.75 mg and 3.5 mg of Zolpidem®.” NCT03885141 ↗ |
| Known as | Ambien | “This study will compare the interactions of a placebo and two FDA-approved sleeping medications, Eszopiclone (Lunesta) and Zolpidem (Ambien), with certain chemical receptors in...” NCT00781482 ↗7“This study will evaluate the long- and short-term effects of cognitive-behavior therapy (CBT), alone and in combination with zolpidem (Ambien®), for chronic insomnia.” NCT00042146 ↗ “12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).” NCT01485393 ↗ “10 mg Zolpidem (Ambien) and 10 mg Zaleplon (Sonata)” NCT03526575 ↗ “Oral administration of the drug zolpidem (Ambien)” NCT01809626 ↗ “AMBIEN® tablets(G.D. Searle \& Co.)” NCT00833937 ↗ “zolpidem tartrate (Ambien)” NCT00044629 ↗ |
| Known as | Ambien CR | “12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).” NCT01485393 ↗3“extended-release zolpidem (Ambien CR®) can improve quit rates among people trying to stop using marijuana” NCT01685073 ↗ “To assess sleep satisfaction before and after Zolpidem CR (Ambien CR) administration” NCT01097382 ↗ “Zolpidem Tartrate Extended-Release (Ambien CR)” NCT00296790 ↗ |
| Known as | Myslee | “The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) in patients with insomnia by a randomized, double-blind, group-comparison...” NCT00283946 ↗ |
| Known as | Patz | “Patz - 5mg sublingual zolpidem hemitartrate” NCT01896336 ↗ |
| Known as | SL800750 | “zolpidem-MR (SL800750)” NCT00425243 ↗ |
| Known as | Stilnox | “sedative-hypnotic drugs (such as stilnox) are often used to treat insomnia.” NCT06095258 ↗1“Stilnox - 10mg oral zolpidem hemitartrate” NCT01896336 ↗ |
| Known as | ZOL | “compared with placebo (PBO) and supratherapeutic doses of zolpidem (ZOL) 30 mg and suvorexant (SUV) 40 mg.” PMID 35748777 ↗ Jun 20223“The research involves oral administration of zolpidem (ZOL) or placebo during sleep with EEG recording.” NCT03657212 ↗ “Patients were first treated with behavioral therapy (BT) or zolpidem (Zol).” PMID 34792177 ↗ Jan 2022 “zolpidem tartrate extended release 6.25 mg (ZOL)” PMID 39120786 ↗ Aug 2024 |
| Known as | Zolpidem CR | “OBJECTIVE: The authors sought to determine whether targeted treatment of insomnia with controlled-release zolpidem (zolpidem-CR) in suicidal adults with insomnia would provide...” PMID 31537089 ↗ Sep 20191“To assess sleep satisfaction before and after Zolpidem CR (Ambien CR) administration” NCT01097382 ↗ |
| Known as | zolpidem hemitartarate | “zolpidem hemitartarate orodispersible tablet 1.75 mg” NCT02814058 ↗ |
| Known as | Zolpidem MR | “The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) in patients with insomnia by a randomized, double-blind, group-comparison...” NCT00283946 ↗ |
| Known as | Zolpidem Orodispersible | “Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women” NCT03885141 ↗ |
| Known as | Zolpidem Tartrate | “The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.” NCT00466193 ↗10“3.5 mg zolpidem tartrate sublingual tablet taken either 3 or 4 hours prior to driving.” NCT01106859 ↗ “Zolpidem Tartrate 10 mg tablet, taken orally at bed time for 2 consecutive nights.” NCT00770510 ↗ “zolpidem tartrate sublingual tablet 3.5mg” NCT00380081 ↗ “Zolpidem tartrate 10 mg tablets” NCT00833937 ↗ “zolpidem tartrate (Ambien)” NCT00044629 ↗ “Drug: Zolpidem Tartrate” NCT03307005 ↗ “Zolpidem Tartrate 10 mg” NCT06303076 ↗ |
| Known as | Zolpidem Tartrate Tablets | “Drug: Zolpidem Tartrate Tablets” NCT02948660 ↗ |
| Known as | zolpidem-ER | “AIMS: This secondary analysis examined the relationship of age to insomnia and the impact of age on the treatment of insomnia with zolpidem extended-release (zolpidem-ER) in...” PMID 39119911 ↗ Aug 2024 |
| Known as | ZST | “STUDY OBJECTIVE: To evaluate next-morning driving performance after middle-of-the-night use of zolpidem 3.5 mg in a buffered sublingual formulation (ZST).” PMID 24587571 ↗ Mar 2014 |
| Action | Activate | “The benzodiazepine receptor agonist (BzRA), zolpidem” NCT00177216 ↗ |
| Modality | Small molecule | “Zolpidem is an imidazopyridine hypnotic” PMID 10221356 ↗ 1999 |
| Route | Oral | “Patients receive oral zolpidem once daily for 5 weeks” NCT00084669 ↗ |