Zolpidem
Ambien, Edluar, Zolpidem (zolpidem) is a small molecule pharmaceutical. Zolpidem was first approved as Ambien on 1992-12-16. It is used to treat sleep initiation and maintenance disorders in the USA. The pharmaceutical is active against gamma-aminobutyric acid receptor subunit alpha-1. In addition, it is known to target gamma-aminobutyric acid receptor subunit alpha-2 and gamma-aminobutyric acid receptor subunit alpha-3.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
Ambien, Edluar, Zolpidem (discontinued: Intermezzo, Tovalt, Zolpidem, Zolpimist)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Zolpidem tartrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZOLPIDEM TARTRATE | Almatica Pharma | N-215721 RX | 2023-05-09 | 1 products, RLD, RS |
| AMBIEN | Cosette Pharmaceuticals | N-019908 RX | 1992-12-16 | 2 products, RLD, RS |
| AMBIEN CR | Cosette Pharmaceuticals | N-021774 RX | 2005-09-02 | 2 products, RLD |
| EDLUAR | Viatris | N-021997 RX | 2009-03-13 | 2 products, RLD, RS |
Show 3 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ambien | New Drug Application | 2025-04-15 |
| ambien cr | New Drug Application | 2012-09-04 |
| edluar | New Drug Application | 2022-08-15 |
| gabazolpidem-5 | unapproved drug other | 2011-08-01 |
| sentrazolpidem pm-5 | unapproved drug other | 2011-08-01 |
| zolpidem | ANDA | 2025-05-22 |
| zolpidem tartrate | ANDA | 2025-08-08 |
| zolpidem tartrate sublingual | ANDA | 2019-10-10 |
| zolpidem tartrate zolpidem tartrate | ANDA | 2016-02-02 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| sleep initiation and maintenance disorders | — | D007319 | F51.01 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Zolpidem Tartrate, Zolpimist, Aytu | |||
| 8236285 | 2032-08-07 | DS, DP | U-70 |
| Zolpidem Tartrate, Edluar, Mylan Speciality Lp | |||
| 9265720 | 2031-02-25 | U-674 | |
| 9597281 | 2027-04-06 | U-674 | |
| Zolpidem Tartrate, Intermezzo, Purdue Pharma | |||
| 8242131 | 2029-08-20 | U-1266 | |
| 7658945 | 2027-04-15 | DP | U-1194 |
| 7682628 | 2025-02-16 | U-1194 | |
| 8252809 | 2025-02-16 | DP | |
HCPCS
No data
Clinical
Clinical Trials
146 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | 10 | 13 | 21 | 22 | 8 | 70 |
| Healthy volunteers/patients | — | — | — | 13 | 1 | — | 3 | 4 | 20 |
| Sleep wake disorders | D012893 | — | G47 | 3 | 1 | 2 | 5 | 6 | 16 |
| Parasomnias | D020447 | — | G47.5 | 2 | 1 | 1 | 1 | 6 | 10 |
| Sleep | D012890 | GO_0030431 | — | 1 | 1 | 1 | 2 | 3 | 8 |
| Depression | D003863 | — | F33.9 | 2 | — | 1 | 4 | — | 7 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | 1 | 2 | 3 |
| Sleep apnea syndromes | D012891 | EFO_0003877 | G47.3 | — | — | — | 3 | — | 3 |
| Dyssomnias | D020920 | — | — | 1 | — | — | 1 | 1 | 3 |
| Consciousness disorders | D003244 | — | — | — | 1 | — | 1 | — | 2 |
Show 24 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | — | 1 | — | 1 | 2 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | 1 | — | 1 | 2 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | 1 | — | 1 | 2 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | 2 | — | — | 2 |
| Hyperkinesis | D006948 | — | — | — | — | 1 | — | 1 | 2 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | — | 1 | — | 1 | 2 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | 1 | 1 | — | 1 | 2 |
| Psychophysiologic disorders | D011602 | — | F45.9 | — | — | 1 | — | — | 1 |
| Somatoform disorders | D013001 | — | F45 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 2 | — | — | — | 2 |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | — | 1 | — | — | 1 | 2 |
| Burns | D002056 | — | T30.0 | — | 1 | — | — | — | 1 |
| Low back pain | D017116 | — | M54.5 | 1 | 1 | — | — | — | 1 |
| Back pain | D001416 | — | M54 | 1 | 1 | — | — | — | 1 |
| Autism spectrum disorder | D000067877 | — | F84.0 | — | 1 | — | — | — | 1 |
| Post-acute covid-19 syndrome | D000094024 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug misuse | D000076064 | — | — | 2 | — | — | — | — | 2 |
| Dystonic disorders | D020821 | — | G24 | 1 | — | — | — | — | 1 |
| Marijuana abuse | D002189 | EFO_0007191 | F12 | 1 | — | — | — | — | 1 |
| Recreational drug use | D000084783 | — | — | 1 | — | — | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | — | 1 |
| Postoperative complications | D011183 | — | — | 1 | — | — | — | — | 1 |
| Shoulder pain | D020069 | — | M25.51 | 1 | — | — | — | — | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 3 | 3 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 2 | 2 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 2 | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 2 | 2 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 2 | 2 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 2 | 2 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 2 | 2 |
| Hyperaldosteronism | D006929 | — | E26 | — | — | — | — | 2 | 2 |
| Pulmonary arterial hypertension | D000081029 | — | — | — | — | — | — | 2 | 2 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | — | — | 2 | 2 |
Show 72 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Zolpidem |
| INN | zolpidem |
| Description | Zolpidem is an imidazo[1,2-a]pyridine compound having a 4-tolyl group at the 2-position, an N,N-dimethylcarbamoylmethyl group at the 3-position and a methyl substituent at the 6-position. It has a role as a central nervous system depressant, a GABA agonist and a sedative. |
| Classification | Small molecule |
| Drug class | hypnotics/sedatives (zolpidem type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1ccc(-c2nc3ccc(C)cn3c2CC(=O)N(C)C)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 82626-48-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL911 |
| ChEBI ID | 10125 |
| PubChem CID | 5732 |
| DrugBank | DB00425 |
| UNII ID | 7K383OQI23 (ChemIDplus, GSRS) |
Target
Agency Approved
GABRA1
GABRA1
Organism
Homo sapiens
Gene name
GABRA1
Gene synonyms
NCBI Gene ID
Protein name
gamma-aminobutyric acid receptor subunit alpha-1
Protein synonyms
GABA(A) receptor subunit alpha-1, GABA(A) receptor, alpha 1, gamma-aminobutyric acid (GABA) A receptor, alpha 1, gamma-aminobutyric acid type A receptor alpha1 subunit
Uniprot ID
Mouse ortholog
Gabra1 (14394)
gamma-aminobutyric acid receptor subunit alpha-1 (P62812)
Alternate
GABRA2
GABRA2
GABRA3
GABRA3
Organism
Homo sapiens
Gene name
GABRA2
Gene synonyms
NCBI Gene ID
Protein name
gamma-aminobutyric acid receptor subunit alpha-2
Protein synonyms
GABA(A) receptor subunit alpha-2, gamma-aminobutyric acid type A receptor alpha2 subunit
Uniprot ID
Mouse ortholog
Gabra2 (14395)
gamma-aminobutyric acid receptor subunit alpha-2 (P26048)
Variants
No data
Financial
Revenue by drug
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Estimated US medical usage
Zolpidem
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Ambien, Edluar, Zolpidem, Zolpidem tartrate, Zolpidem tartrate sublingual
Adverse Events
Top Adverse Reactions
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40,145 adverse events reported
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