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AboutPricing
Drug ReportsEszopiclone
Eszopiclone
Eszopiclone, Lunesta (eszopiclone) is a small molecule pharmaceutical. Eszopiclone was first approved as Lunesta on 2004-12-15. It is used to treat sleep initiation and maintenance disorders in the USA.
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Financial
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3M
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2Y
5Y
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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
Lunesta (generic drugs available since 2011-05-23)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Eszopiclone
Tradename
Company
Number
Date
Products
LUNESTAWoodward Pharma ServicesN-021476 RX2004-12-15
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
eszopicloneANDA2024-09-25
lunestaNew Drug Application2023-12-07
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05C: Hypnotics and sedatives
— N05CF: Benzodiazepine related hypnotics and sedatives
— N05CF04: Eszopiclone
HCPCS
No data
Clinical
Clinical Trials
72 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—F51.012216181147
Obstructive sleep apneaD020181EFO_0003918G47.3326—3212
Sleep apnea syndromesD012891HP_0010535G47.315—3211
ApneaD001049HP_0002104R06.8113—217
Depressive disorderD003866EFO_1002014F32.A——24—6
DepressionD003863—F33.9——23—5
Healthy volunteers/patients———2—11—4
Major depressive disorderD003865EFO_0003761F22——22—4
Sleep wake disordersD012893—G47—1—124
ParasomniasD020447—G47.5———3—3
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperkinesisD006948HP_0000752———2——2
Attention deficit disorder with hyperactivityD001289EFO_0003888F90——2——2
Rheumatoid arthritisD001172EFO_0000685M06.9——1——1
ArthritisD001168HP_0001369M05-M14——1——1
Parkinson diseaseD010300EFO_0002508G20——1——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prediabetic stateD011236EFO_1001121R73.031————1
Diabetes mellitusD003920HP_0000819E08-E131————1
Glucose intoleranceD018149HP_0000833R73.031————1
MalnutritionD044342EFO_0008572E40-E461————1
Marijuana abuseD002189EFO_0007191F121————1
Therapeutic equivalencyD013810——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SchizophreniaD012559EFO_0000692F20————33
Circadian rhythm sleep disordersD020178—G47.2————11
Psychotic disordersD011618—F20.81————11
Multiple sclerosisD009103EFO_0003885G35————11
FatigueD005221HP_0012378R53.83————11
Relapsing-remitting multiple sclerosisD020529EFO_0003929—————11
SclerosisD012598——————11
OsteoarthritisD010003EFO_0002506M15-M19————11
MenopauseD008593EFO_0003922N95————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEszopiclone
INNeszopiclone
Description
Eszopiclone is the (5S)- (active) enantiomer of zopiclone. Unlike almost all other hypnotic sedatives, which are approved only for the relief of short-term (6-8 weeks) insomnia, eszopiclone is approved by the U.S. Food and Drug Administration for long-term use. It has a role as a sedative and a central nervous system depressant. It is an enantiomer of a (5R)-zopiclone.
Classification
Small molecule
Drug classhypnotics/tranquilizers (zopiclone type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN1CCN(C(=O)O[C@H]2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Identifiers
PDB—
CAS-ID138729-47-2
RxCUI—
ChEMBL IDCHEMBL1522
ChEBI ID53760
PubChem CID969472
DrugBankDB00402
UNII IDUZX80K71OE (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Eszopiclone
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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,037 documents
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Safety
Black-box Warning
Black-box warning for: Eszopiclone, Lunesta
Adverse Events
Top Adverse Reactions
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13,074 adverse events reported
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