zolpidem
Trade name: ambien
Approved
Dec 16, 1992
Zolpidem is usually used for the treatment of insomnia as a hypnotic drug. It was also suggested to be effective in the treatment of dystonia in some studies. Zolpidem can be one of useful alternative pharmacological treatments for blepharospasm. Zolpidem interacts with a GABA-BZ receptor complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which non-selectively bind to and activate all BZ receptor subtypes, zolpidem in vitro binds the BZ1 receptor preferentially with a high affinity ratio of the α1/α5 subunits. This selective binding of zolpidem on the BZ1 receptor is not absolute, but it may explain the relative absence of myorelaxant and anticonvulsant effects in animal studies as well as the preservation of deep sleep in human studies of zolpidem tartrate at hypnotic doses. — NCATS
Clinical trial activity
136 trials · 126 clinical orgs · 35 marketing orgs
Earliest trial started Sep 1, 2001 (NCT00044629)
Timeline
1990s
- Dec 16, 1992
Earliest FDA Approval
- Dec 16, 1992
Sanofi-Aventis — NDA Secondary Org
2000s
- Jan 1, 2001
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2002
- Jan 1, 2003
Earliest Phase 3 Sponsor(trial)
- May 24, 2006
Byondis — Marketing Organization
- Oct 30, 2006
Mylan — Marketing Organization
- Apr 23, 2007
Rising Pharmaceuticals — Marketing Organization
- Apr 23, 2007
ACME Laboratories — Marketing Organization
- Apr 23, 2007
Apotex — Marketing Organization
- Apr 23, 2007
Teva — Marketing Organization
- Apr 23, 2007
Sandoz — Marketing Organization
- Apr 23, 2007
Strides Pharma Science — Marketing Organization
- Apr 23, 2007
Sun Pharmaceuticals — Marketing Organization
- Apr 23, 2007
Watson Pharmaceuticals — Marketing Organization
- Apr 23, 2007
Yung Shin Pharm. Ind. Co., Ltd. — Marketing Organization
- Apr 23, 2007
Novartis — Marketing Organization
- Apr 25, 2007
Biovail — NDA Secondary Org
- May 4, 2007
Aurobindo Pharma — Marketing Organization
- May 15, 2007
Wockhardt — Marketing Organization
- Aug 17, 2007
Torrent Pharmaceuticals Limited — Marketing Organization
- Sep 7, 2007
Invagen Pharms — Marketing Organization
- Apr 30, 2008
Hikma — Marketing Organization
- Nov 21, 2008
Vintage — Marketing Organization
- Dec 19, 2008
AYTU BioScience — NDA Secondary Org
- Mar 13, 2009
Mylan — NDA Secondary Org
2010s
- Oct 13, 2010
Actavis — Marketing Organization
- Dec 3, 2010
Anchen Pharmaceuticals, Inc — Marketing Organization
- Nov 23, 2011
Purdue Pharmaceuticals — NDA Secondary Org
- Jul 30, 2012
Chartwell Pharmaceuticals — Marketing Organization
- Jul 30, 2012
Cipla — Marketing Organization
- Sep 11, 2013
Lupin — Marketing Organization
- Jun 3, 2015
Novel Anti-Infective Technologies, LLC — Marketing Organization
- Aug 1, 2016
Par Pharmaceuticals — Marketing Organization
- Aug 1, 2016
Bristol-Myers Squibb — Marketing Organization
- Nov 18, 2016
Dr. Reddy's Laboratories — Marketing Organization
2020s
- Jun 4, 2020
Centaur Pharmaceuticals — Marketing Organization
- Jun 4, 2020
Esteve Labs — Marketing Organization
- May 9, 2023
Alvogen — Marketing Organization
- May 9, 2023
Alvogen — NDA Secondary Org
Indications
Studied for
- Abdominoplasty · Phase 4
- Acute Coronary Syndrome · Phase 4
- Aging · Phase 4
- Anemia, Iron-Deficiency · Phase 3
- Anxiety Disorders · Phase 3
- Arthritis · Phase 1
- Arthroplasty · Phase 1
- Attention Deficit Disorder with Hyperactivity · Phase 3
- Autism Spectrum Disorder · Phase 2
- Autistic Disorder · Phase 2
- Back Pain · Phase 1/Phase 2
- Burns · Phase 2
- Cognition · Phase 4
- Consciousness Disorders · Phase 2
- Delirium · Phase 4
- Dementia · Phase 3
- Depression · Phase 4
- Dystonic Disorders · Early Phase 1
- Healthy Volunteers · Phase 4
- Heart Failure · Phase 4
- Hip Fractures · Phase 4
- Major Depressive Disorder · Phase 4
- Marijuana Abuse · Phase 1
- Memory · Phase 4
- Obesity · Phase 1
- Osteoporosis, Postmenopausal · Phase 4
- Parkinson Disease · Phase 2
- Performance-Enhancing Substances · Early Phase 1
- Pharmacokinetics · Early Phase 1
- Pharmacologic Actions · Phase 4
- Postoperative Complications · Phase 1
- Posture · Phase 4
- Prostatic Neoplasms · Phase 1
- Psychomotor Disorders · Phase 4
- Psychophysiologic Disorders · Phase 3
- Schizophrenia · Phase 3
- Sleep · Phase 4
- Sleep Apnea, Obstructive · Phase 4
- Sleep Apnea Syndromes · Phase 4
- Sleep Deprivation · Phase 4
- Sleep Disorders, Intrinsic · Phase 4
- Sleep Initiation and Maintenance Disorders · Phase 4
- Sleep Wake Disorders · Phase 4
- Substance Abuse, Oral · Phase 1
- Substance-Related Disorders · Phase 2/Phase 3
- Suicidal Ideation · Phase 4
- Therapeutic Equivalency · Phase 1
- Therapeutics · Phase 4
Mechanism of action
LHFPL4 agonist
Approval history
- approvedDec 16, 1992
Chemistry & pharmacology
SMILES
CN(C)C(=O)CC1=C(N=C2C=CC(C)=CN12)C3=CC=C(C)C=C3- Mol. weight
- 307.3895 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaZolpidem ↗
- NCATS7K383OQI23 ↗
- ChEMBLCHEMBL911 ↗
- ChEMBLCHEMBL1723343 ↗
Also known as
- ambien
- ambien
- ambien
- ambien
- ambien
- ambien
- ambien
- ambien
- ambien cr
- amsic
- bikalm
- dalparan
- intermezzo
- intermezzo
- n,n,6-trimethyl-2-(4-methylphenyl)imidazo(1,2-a)pyridine-3-acetamide
- n,n,6-trimethyl-2-(4-methylphenyl)imidazo(1,2-a)pyridine-3-acetamide
- n,n,6-trimethyl-2-(4-methylphenyl)imidazo(1,2a)pyridine-3-acetamide hemitartrate
- sl 80.0750
- sl-80.0750-23n
- sl-80.0750-23n
- sl-800750-23n
- sl-800750-23n
- sl-800750-23-n
- stilnoct
- stilnoct
- stilnoct
- stilnox
- tovalt odt
- z-213
- zodormdura
- zoldem
- zolipidem
- zolirin
- zolpidem
- zolpidem
- zolpidem
- zolpidem
- zolpidem
- zolpidem
- zolpidem
- zolpidem
- zolpidem
- zolpidem 1a pharma
- zolpidem abz
- zolpidem tartrate
- zolpidem tartrate
- zolpidem tartrate
- zolpidem tartrate
- zolpidem tartrate
- zolpidemum
- zolpidemum
- zolpi-lich
- zolpimist
- zolpimist
- zolpimist
- zolpinox
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06767150 | Phase 4 | Mar 31, 2025 | University of Toulouse |
| NCT06975514 | Phase 3 | Mar 25, 2025 | Shanghai Haiyan Pharmaceutical Technology Co., Ltd. |
| NCT06740188 | Phase 4 | Jan 1, 2025 | Huazhong University of Science and Technology |
| NCT06303076 | Phase 4 | Sep 30, 2024 | Sultan Qaboos University |
| NCT06512155 | Phase 1 | Jul 31, 2024 | Sichuan University |
| NCT06800378 | Phase 4 | Jun 26, 2024 | National Taiwan University, Ten-Chan General Hospital |
| NCT06244277 | N/A | Dec 22, 2023 | Nanjing Medical University |
| NCT06084130 | Phase 4 | Oct 15, 2023 | Siriraj Hospital |
| NCT05351541 | Phase 1/Phase 2 (Phase 2) | Jan 31, 2023 | University of California, San Francisco |
| NCT05540574 | Phase 2 | Jan 1, 2023 | National Institutes of Health (NIH), Stanford University |
| NCT05764798 | Phase 1 | Nov 30, 2022 | Southern Medical University |
| NCT05615727 | Phase 3 | Sep 1, 2022 | The University of Hong Kong |
| NCT05746143 | N/A | Feb 1, 2022 | University of Southern California |
| NCT05106153 | Phase 1 | Nov 5, 2021 | Janssen Pharmaceutica NV |
| NCT04468776 | Phase 4 | Dec 31, 2020 | Patient-Centered Outcomes Research Institute, University of Arizona, University of California, San Francisco, University of Illinois at Chicago, University of Pittsburgh, University of Virginia |
| NCT04396327 | Phase 2 | May 27, 2020 | Clinilabs, Sequential Medicine Ltd |
| NCT04118387 | Phase 4 | Apr 1, 2020 | Department of Veteran Affairs |
| NCT04273776 | Early Phase 1 (Phase 1) | Dec 1, 2019 | United States Army |
| NCT03885141 | Phase 2/Phase 3 (Phase 3) | Sep 30, 2019 | Biolab Sanus Farmaceutica |
| NCT04102345 | Early Phase 1 (Phase 1) | Sep 4, 2019 | HealthPartners Institute |
Organizations
Research & Development (126)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Sanofi | For profit | 12 | 11 | 3 | 2003 |
| Astellas | For profit | 7 | 7 | 2 | 2006 |
| National Institutes of Health (NIH) | Government | 7 | 1 | 3 | 2002 |
| National Institute of Mental Health (NIMH) | Government | 6 | 0 | 3 | 2001 |
| Eisai | For profit | 5 | 5 | 2 | 2008 |
| Biolab Sanus Farmaceutica | For profit | 4 | 4 | 2 | 2016 |
| Harvard University | Academic/Hospital | 4 | 4 | 2 | 2003 |
| Henry Ford Health System | Academic/Hospital | 4 | 1 | 2 | 2006 |
| National Institute on Drug Abuse (NIDA) | Government | 4 | 0 | 3 | 2008 |
| University of California, San Francisco | Academic/Hospital | 4 | 4 | 3 | 2017 |
| University of Pennsylvania | Academic/Hospital | 4 | 3 | 2 | 2005 |
| Clinilabs | For profit | 3 | 0 | 2 | 2011 |
| Department of Veteran Affairs | Government | 3 | 1 | 1 | 2018 |
| Duke University | Academic/Hospital | 3 | 1 | 3 | 2001 |
| Johns Hopkins University | Academic/Hospital | 3 | 3 | 3 | 2008 |
| Transcept Pharmaceuticals | For profit | 3 | 3 | 2 | 2006 |
| United States Army | Government | 3 | 1 | 3 | 2011 |
| University of Pittsburgh | Academic/Hospital | 3 | 2 | 2 | 2002 |
| Zeria Pharmaceutical | For profit | 3 | 3 | 2 | 2014 |
| Actelion | For profit | 2 | 2 | 1 | 2016 |
Marketing (50)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ACME Laboratories | For profit | MKTG | Apr 23, 2007 |
| AYTU BioScience | For profit | NDA2 | Dec 19, 2008 |
| Actavis | For profit | MKTG | Oct 13, 2010 |
| Actavis | For profit | SYN | Mar 25, 2013 |
| Alvogen | For profit | MKTG | May 9, 2023 |
| Alvogen | For profit | NDA2 | May 9, 2023 |
| Anchen Pharmaceuticals, Inc | For profit | MKTG | Dec 3, 2010 |
| Apotex | For profit | MKTG | Apr 23, 2007 |
| Apotex | For profit | SYN | Sep 10, 2013 |
| Aurobindo Pharma | For profit | MKTG | May 4, 2007 |
| Biovail | For profit | NDA2 | Apr 25, 2007 |
| Bristol-Myers Squibb | For profit | MKTG | Aug 1, 2016 |
| Byondis | For profit | MKTG | May 24, 2006 |
| Centaur Pharmaceuticals | For profit | MKTG | Jun 4, 2020 |
| Chartwell Pharmaceuticals | For profit | MKTG | Jul 30, 2012 |
| Cipla | For profit | MKTG | Jul 30, 2012 |
| Dr. Reddy's Laboratories | For profit | MKTG | Nov 18, 2016 |
| Dr. Reddy's Laboratories | For profit | SYN | Apr 23, 2007 |
| Dr. Reddy's Laboratories | For profit | SYN | Nov 18, 2016 |
| Esteve Labs | For profit | MKTG | Jun 4, 2020 |
| Hikma | For profit | MKTG | Apr 30, 2008 |
| Invagen Pharms | For profit | MKTG | Sep 7, 2007 |
| Lorex Pharmaceuticals | For profit | NDA | — |
| Lupin | For profit | MKTG | Sep 11, 2013 |
| Mylan | For profit | NDA2 | Mar 13, 2009 |
| Mylan | For profit | SYN | Apr 23, 2007 |
| Mylan | For profit | MKTG | Oct 30, 2006 |
| Novartis | For profit | MKTG | Apr 23, 2007 |
| Novel Anti-Infective Technologies, LLC | For profit | MKTG | Jun 3, 2015 |
| Par Pharmaceuticals | For profit | MKTG | Aug 1, 2016 |
| Par Pharmaceuticals | For profit | SYN | Sep 11, 2017 |
| Purdue Pharmaceuticals | For profit | NDA2 | Nov 23, 2011 |
| Rising Pharmaceuticals | For profit | MKTG | Apr 23, 2007 |
| Rising Pharmaceuticals | For profit | SYN | Apr 23, 2007 |
| Sandoz | For profit | SYN | Jul 1, 2011 |
| Sandoz | For profit | MKTG | Apr 23, 2007 |
| Sanofi-Aventis | For profit | NDA2 | Dec 16, 1992 |
| Strides Pharma Science | For profit | MKTG | Apr 23, 2007 |
| Strides Pharma Science | For profit | SYN | Apr 23, 2007 |
| Sun Pharmaceuticals | For profit | SYN | Jan 24, 2017 |
| Sun Pharmaceuticals | For profit | MKTG | Apr 23, 2007 |
| Sun Pharmaceuticals | For profit | SYN | Apr 23, 2007 |
| Sun Pharmaceuticals | For profit | SYN | Apr 23, 2007 |
| Sun Pharmaceuticals | For profit | SYN | Jan 24, 2017 |
| Teva | For profit | MKTG | Apr 23, 2007 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Aug 17, 2007 |
| Vintage | For profit | MKTG | Nov 21, 2008 |
| Watson Pharmaceuticals | For profit | MKTG | Apr 23, 2007 |
| Wockhardt | For profit | MKTG | May 15, 2007 |
| Yung Shin Pharm. Ind. Co., Ltd. | For profit | MKTG | Apr 23, 2007 |