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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Commercial
Trade Name
FDA
EMA
Lunesta (generic drugs available since 2011-05-23)
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Eszopiclone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LUNESTA | Woodward Pharma Services | N-021476 RX | 2004-12-15 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| eszopiclone | ANDA | 2023-06-07 |
| lunesta | New Drug Application | 2021-09-13 |
Agency Specific
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
65 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 | 2 | 2 | 16 | 16 | 9 | 43 | |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | 2 | 4 | — | 2 | 1 | 8 |
| Healthy volunteers/patients | — | 2 | — | 1 | 1 | — | 4 | ||
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | 2 | 1 | — | 3 |
| Sleep wake disorders | D012893 | G47 | — | 1 | — | 1 | 1 | 3 | |
| Sleep | D012890 | GO_0030431 | — | 1 | — | 1 | — | 2 | |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | — | — | 2 | — | 2 |
| Depression | D003863 | F33.9 | — | — | — | 2 | — | 2 | |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | 1 | — | 1 | — | 2 |
| Tobacco use disorder | D014029 | F17 | — | — | — | 1 | — | 1 |
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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 | — | — | 2 | — | — | 2 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | 1 | — | — | 1 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep apnea syndromes | D012891 | EFO_0003877 | G47.3 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | 1 | — | — | — | — | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | 1 | — | — | — | — | 1 |
| Marijuana abuse | D002189 | EFO_0007191 | F12 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | — | — | 3 | 3 |
| Circadian rhythm sleep disorders | D020178 | G47.2 | — | — | — | — | 1 | 1 | |
| Psychotic disorders | D011618 | F20.81 | — | — | — | — | 1 | 1 | |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | — | — | 1 | 1 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | — | — | 1 | 1 | |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | — | — | — | 1 | 1 |
| Menopause | D008593 | EFO_0003922 | N95 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ESZOPICLONE |
| INN | eszopiclone |
| 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 class | hypnotics/tranquilizers (zopiclone type) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CN1CCN(C(=O)O[C@H]2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 138729-47-2 |
| RxCUI | 461016 |
| ChEMBL ID | CHEMBL1522 |
| ChEBI ID | 53760 |
| PubChem CID | 969472 |
| DrugBank | DB00402 |
| UNII ID | UZX80K71OE (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
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Trends
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Safety
Black-box Warning
Black-box warning for: Eszopiclone, Lunesta
Adverse Events
Top Adverse Reactions
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22,236 adverse events reported
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