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Drug ReportsZolpidem
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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EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
mental disordersD001523
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 TARTRATEAlmatica PharmaN-215721 RX2023-05-09
1 products, RLD, RS
AMBIENCosette Pharmaceuticals N-019908 RX1992-12-16
2 products, RLD, RS
AMBIEN CRCosette Pharmaceuticals N-021774 RX2005-09-02
2 products, RLD
EDLUARViatrisN-021997 RX2009-03-13
2 products, RLD, RS
Show 3 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
ambienNew Drug Application2025-04-15
ambien crNew Drug Application2012-09-04
edluarNew Drug Application2022-08-15
gabazolpidem-5unapproved drug other2011-08-01
sentrazolpidem pm-5unapproved drug other2011-08-01
zolpidemANDA2025-05-22
zolpidem tartrateANDA2025-08-08
zolpidem tartrate sublingualANDA2019-10-10
zolpidem tartrate zolpidem tartrateANDA2016-02-02
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
sleep initiation and maintenance disorders—D007319F51.01
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Zolpidem Tartrate, Zolpimist, Aytu
82362852032-08-07DS, DPU-70
Zolpidem Tartrate, Edluar, Mylan Speciality Lp
92657202031-02-25U-674
95972812027-04-06U-674
Zolpidem Tartrate, Intermezzo, Purdue Pharma
82421312029-08-20U-1266
76589452027-04-15DPU-1194
76826282025-02-16U-1194
82528092025-02-16DP
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05C: Hypnotics and sedatives
— N05CF: Benzodiazepine related hypnotics and sedatives
— N05CF02: Zolpidem
HCPCS
No data
Clinical
Clinical Trials
146 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1————1
Sleep initiation and maintenance disordersD007319—F51.011————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameZolpidem
INNzolpidem
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 classhypnotics/sedatives (zolpidem type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1ccc(-c2nc3ccc(C)cn3c2CC(=O)N(C)C)cc1
Identifiers
PDB—
CAS-ID82626-48-0
RxCUI—
ChEMBL IDCHEMBL911
ChEBI ID10125
PubChem CID5732
DrugBankDB00425
UNII ID7K383OQI23 (ChemIDplus, GSRS)
Target
Agency Approved
GABRA1
GABRA1
Organism
Homo sapiens
Gene name
GABRA1
Gene synonyms
NCBI Gene ID
2554
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
Q8N629
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
2555
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
Q59G14
Mouse ortholog
Gabra2 (14395)
gamma-aminobutyric acid receptor subunit alpha-2 (P26048)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
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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Additional graphs summarizing 10,212 documents
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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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