Drugs / Zolpidem
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Zolpidem

Small molecule

Developed for
insomnia · sleep disorder, initiating and maintaining sleep · sleep disorder · Parkinson disease · acute coronary syndrome · attention deficit-hyperactivity disorder · autism · cannabis dependence
+10 more · cirrhosis of liver · cognitive disorder · delirium · drug dependence · obstructive sleep apnea syndrome · sleep apnea syndrome · anxiety · central sleep apnea syndrome · circadian rhythm sleep disorder · focal dystonia
Investigated by
Sanofi · Astellas Pharma Inc · National Institute of Mental Health (NIMH) · National Institutes of Health (NIH) · Biolab Sanus Farmaceutica · National Institute on Drug Abuse (NIDA)
+80 more · Sequential Medicine Ltd · University of Pennsylvania · Eisai Inc. · Johns Hopkins University · Transcept Pharmaceuticals · University of Pittsburgh · Associação Fundo de Incentivo à Pesquisa · EMS · Janssen Research & Development, LLC · Massachusetts General Hospital · Mclean Hospital · National Institute on Aging (NIA) · Patient-Centered Outcomes Research Institute · Purdue Pharma LP · Sanofi-Synthelabo · Takeda · AO North America · Abiant, Inc. · American Academy of Sleep Medicine · Astellas Pharma Taiwan, Inc. · Aston University · Brain & Behavior Research Foundation · Brasilia University Hospital · California Pacific Medical Center Research Institute · Centre d'Expertise sur l'Altitude EXALT · Children's Hospital Medical Center, Cincinnati · Clinilabs, Inc. · Conselho Nacional de Desenvolvimento Científico e Tecnológico · Duke University · Eli Lilly and Company · Emory University · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Food and Drug Administration (FDA) · GlaxoSmithKline · Guangzhou University of Chinese Medicine · Hadine Joffe, MD · Hannover Medical School · Hvidovre University Hospital · IMK Fonden · Idorsia Pharmaceuticals Ltd. · Institute of Liver and Biliary Sciences, India · Janssen-Cilag International NV · Johannes Gutenberg University Mainz · Joshua Woolley, MD, PhD · Kettering Health Network · Laval University · Marion Coe · Mengchang Yang · Midnight Pharma, LLC · National Cancer Institute (NCI) · National Center for Complementary and Integrative Health (NCCIH) · National Center for Research Resources (NCRR) · National Heart, Lung, and Blood Institute (NHLBI) · National Taiwan Normal University · Neurogen Corporation · Pfizer · Philipps University Marburg · Philipps University Marburg Coordination Centre for Clinical Trials · Rigshospitalet, Denmark · Rush University Medical Center · Shriners Hospitals for Children · Siriraj Hospital · St. Luke's Hospital, Chesterfield, Missouri · Stanford University · Sumitomo Pharma America, Inc. · Ten-Chen General Hospital · Teva Pharmaceuticals USA · Tianjin University · University Hospital Birmingham NHS Foundation Trust · University of Arizona · University of California, Irvine · University of California, San Diego · University of California, San Francisco · University of Illinois at Chicago · all 86 on the full record

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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
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1992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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
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
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 No outcome recorded
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 1/22 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 212 trials
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 No outcome recorded
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 NCT00683436 May → Oct 2008 insomnia Neurogen Corporation Terminated No outcome recorded
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
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
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 No outcome recorded
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
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 NCT00380081 Apr → Jul 2006 insomnia Transcept Pharmaceuticals Completed No outcome recorded
Phase 432 trials
Phase 4 NCT07542756 May 2026 → Jan 2032 expected insomnia University of Pennsylvania Recruiting 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 No outcome recorded
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
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 not applicable10 trials
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 No outcome recorded
NCT00936598 Jul 2009 → Apr 2011 endometrium neoplasm University of Pittsburgh Terminated No outcome recorded
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
Also used as a comparator or background therapy in 37 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 03 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 110 trials
Phase 1 NCT05764798 Comparator Nov 2022 → Dec 2024 insomnia Nanfang Hospital, Southern Medical University Unknown No outcome recorded
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 23 trials
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 No outcome recorded
Phase 2 NCT00383643 Comparator May 2006 → Dec 2009 sleep disorder, initiating and maintaining sleep Stanford University Completed No outcome recorded
Phase 2/32 trials
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 No outcome recorded
Phase 35 trials
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 No outcome recorded
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 No outcome recorded
Phase 410 trials
Phase 4 NCT06740188 Comparator Jan 2025 → Dec 2026 expected Tongji University Recruiting No outcome recorded
Phase 4 NCT06303076 Comparator Sep 2024 → Sep 2026 expected 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 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 not applicable4 trials
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

Press releases naming this drug 1 release

DateIssuerRelease
2005-05-29 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces Tentative Approval Of Zolpidem Tartrate Tablets tevapharm.com

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 135 sources stand behind the page.

FieldValueCited 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
124

“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, zolpidemNCT02033707

“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

zolpidem tartrate extended release 6.25 mg (ZOL)” PMID 39120786 Aug 2024

NCT00440323

NCT02353299

NCT01106859

NCT01463098

NCT00494468

NCT00318448

NCT03375203

NCT00359229

NCT00893269

NCT02484963

NCT01159652

NCT03436745

NCT00380081

NCT00283790

NCT02139098

NCT03885141

NCT00283946

NCT00492232

NCT01097382

NCT01809626

NCT00814502

NCT03158025

NCT00784875

NCT02456532

NCT03269760

NCT00286936

NCT00833937

NCT05746143

NCT00676026

NCT00770510

NCT07542756

NCT00653562

NCT00568789

NCT01920334

NCT04720547

NCT03297944

NCT01485393

NCT00833521

NCT02948660

NCT00156533

NCT01689909

NCT03526575

NCT03307005

NCT02096900

NCT00630175

NCT02814058

NCT00292734

NCT04118387

NCT06800378

NCT03056053

NCT05615727

NCT01987739

NCT05764798

NCT00425243

NCT06303076

NCT03657355

NCT04692285

NCT00956319

NCT00086281

NCT03657212

NCT02578472

NCT00999219

NCT01651442

NCT07336277

NCT00383357

NCT00777829

NCT01804036

NCT00374777

NCT06512155

NCT00781482

NCT03160404

NCT01747590

NCT02374567

NCT01685073

NCT00936598

NCT00432198

NCT02607696

NCT01551485

NCT00042146

NCT04102345

NCT00084669

NCT01351168

NCT00530556

NCT00716521

NCT00044629

NCT05540574

NCT00466193

NCT02817750

NCT03075241

NCT01243060

NCT01779830

NCT02778659

NCT03621046

NCT01181232

NCT01896336

NCT00662155

NCT06740188

NCT05351541

NCT05106153

NCT00296179

NCT04014387

NCT06975514

NCT00227942

NCT02839200

NCT00976105

NCT00296790

NCT00940550

NCT06685341

NCT00177216

NCT06244277

NCT04468776

NCT04273776

NCT06084130

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
8

“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

“Zolpidem (Ambien) is an FDA approved, Benzodiazepine Receptor agonist that has been extensively studied for the treatment of insomnia in older adults.” NCT04014387

“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

NCT00833521

Known as Ambien CR “12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).” NCT01485393
4

“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

NCT00683436

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
2

“Zolpidem (SL800750)” NCT00318448

“zolpidem (SL800750)” NCT00630175

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 2022
3

“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 2019
1

“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

Zolpidem Tartrate 10 mg” NCT06303076

“Drug: Zolpidem TartrateNCT03307005

NCT02783729

NCT00383643

NCT03774810

Known as Zolpidem Tartrate Tablets “Drug: Zolpidem Tartrate TabletsNCT02948660
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