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Drug ReportsTemazepam
Temazepam
Restoril, Temazepam (temazepam) is a small molecule pharmaceutical. Temazepam was first approved as Restoril on 1982-01-01. It is used to treat depressive disorder, panic disorder, and sleep initiation and maintenance disorders in the USA.
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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
mental disordersD001523
Trade Name
FDA
EMA
Restoril, Temazepam (discontinued: Temazepam)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Temazepam
Tradename
Company
Number
Date
Products
RESTORILSPECGXN-018163 RX1982-01-01
4 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
restorilNew Drug Application2026-06-09
strazepamunapproved drug other2011-08-01
temazepamNew Drug Application2026-10-06
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05C: Hypnotics and sedatives
— N05CD: Benzodiazepine derivative hypnotics and sedatives
— N05CD07: Temazepam
HCPCS
No data
Clinical
Clinical Trials
13 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 disordersD007319—F51.011——214
Hiv infectionsD015658EFO_0000764B20———1—1
Hiv seropositivityD006679—————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Anxiety disordersD001008EFO_0006788F41.1——1—12
DementiaD003704EFO_0003862F03——1——1
Psychophysiologic disordersD011602—F45.9——1——1
SchizophreniaD012559EFO_0000692F20——1——1
DepressionD003863—F33.9——1——1
Somatoform disordersD013001—F45——1——1
Paroxysmal hemoglobinuriaD006457Orphanet_447D59.12——1——1
HemoglobinuriaD006456—R82.3——1——1
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.9——1——1
Lung diseasesD008171EFO_0003818J98.4——1——1
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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
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Knee osteoarthritisD020370EFO_0004616M17————11
Altitude sicknessD000532EFO_1000782T70.29————11
DyssomniasD020920——————11
ParasomniasD020447—G47.5————11
Pierre robin syndromeD010855—Q87.0————11
PruritusD011537—L29————11
DermatitisD003872—L30.9————11
Otitis externaD010032EFO_0009560H60————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTemazepam
INNtemazepam
Description
Temazepam is a benzodiazepine.
Classification
Small molecule
Drug classantianxiety agents (diazepam type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN1C(=O)C(O)N=C(c2ccccc2)c2cc(Cl)ccc21
Identifiers
PDB—
CAS-ID846-50-4
RxCUI—
ChEMBL IDCHEMBL967
ChEBI ID9435
PubChem CID5391
DrugBankDB00231
UNII IDCHB1QD2QSS (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Temazepam
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 4,326 documents
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Safety
Black-box Warning
Black-box warning for: Restoril, Temazepam
Adverse Events
Top Adverse Reactions
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9,399 adverse events reported
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