Doxepin
Doxepin, Silenor, Zonalon (doxepin) is a small molecule pharmaceutical. Doxepin was first approved as Doxepin hydrochloride on 1982-01-01. It is used to treat anxiety disorders, atopic dermatitis, depressive disorder, pain, and pruritus amongst others in the USA. The pharmaceutical is active against sodium-dependent serotonin transporter and sodium-dependent noradrenaline transporter. In addition, it is known to target histamine H1 receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Doxepin, Silenor, Zonalon (discontinued: Doxepin, Sinequan)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Doxepin hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SILENOR | Currax Pharmaceuticals | N-022036 RX | 2010-03-17 | 2 products, RLD, RS |
| ZONALON | Mylan | N-020126 RX | 1994-04-01 | 1 products, RLD, RS |
Show 3 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| doxepin | ANDA | 2025-05-02 |
| doxepin hcl | ANDA | 2025-07-22 |
| doxepin hydrochloride | ANDA | 2025-10-02 |
| prudoxin | New Drug Application | 2017-06-29 |
| silenor | New Drug Application | 2023-05-08 |
| zonalon | New Drug Application | 2017-06-14 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Doxepin Hydrochloride, Silenor, Currax | |||
| 8513299 | 2030-09-07 | U-620 | |
| 9532971 | 2029-06-01 | DP | |
| 9107898 | 2028-05-01 | U-620 | |
| 9907780 | 2028-04-11 | DP | |
| 10548871 | 2028-04-11 | U-620 | |
| 11096920 | 2028-04-11 | U-620 | |
| 11234954 | 2028-01-18 | U-620 | |
| 7915307 | 2027-08-24 | U-620 | |
| 9572814 | 2027-07-20 | U-620 | |
| 10653660 | 2027-07-20 | U-620 | |
| 11110074 | 2027-07-20 | U-620 | |
| 9486437 | 2027-05-18 | U-620 | |
| 9861607 | 2027-05-18 | U-620 | |
| 10238620 | 2027-05-18 | U-620 | |
| 10653662 | 2027-05-18 | U-620 | |
ATC Codes
D: Dermatologicals
— D04: Antipruritics, incl. antihistamines, anesthetics, etc.
— D04A: Antipruritics, incl. antihistamines, anesthetics, etc.
— D04AX: Other antipruritics in atc
— D04AX01: Doxepin
N: Nervous system drugs
— N06: Psychoanaleptics
— N06A: Antidepressants
— N06AA: Non-selective monoamine reuptake inhibitors
— N06AA12: Doxepin
HCPCS
No data
Clinical
Clinical Trials
21 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pruritus | D011537 | — | L29 | — | — | — | 1 | 3 | 4 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | 1 | 1 | — | 1 | — | 3 |
| Depression | D003863 | — | F33.9 | — | — | 1 | 1 | — | 2 |
| Atrophy | D001284 | — | — | — | — | — | 1 | — | 1 |
| Treatment-resistant depressive disorder | D061218 | — | — | — | — | — | 1 | — | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | 1 | — | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | — | 1 | — | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | 1 | — | 1 |
| Ataxia | D001259 | — | R27.0 | — | — | — | 1 | — | 1 |
| Healthy volunteers/patients | — | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psychophysiologic disorders | D011602 | — | F45.9 | — | — | 1 | — | 1 | 2 |
| Somatoform disorders | D013001 | — | F45 | — | — | 1 | — | 1 | 2 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | — | — | 2 | — | — | 2 |
| Mucositis | D052016 | EFO_1001898 | — | — | — | 2 | — | — | 2 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | 1 | — | — | 1 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | 1 | — | — | 1 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | 1 | — | — | 1 |
| Head and neck neoplasms | D006258 | — | — | — | — | 1 | — | — | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | 1 | — | — | 1 |
| Urticaria | D014581 | EFO_0005531 | L50 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | — | 1 | — | — | 1 | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Dermatitis | D003872 | — | L30.9 | — | 1 | — | — | — | 1 |
| Radiodermatitis | D011855 | — | L58 | — | 1 | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | — | — | — | 1 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | — | 1 | — | — | — | 1 |
| Esophageal neoplasms | D004938 | — | C15 | — | 1 | — | — | — | 1 |
| Lung neoplasms | D008175 | — | C34.90 | — | 1 | — | — | — | 1 |
| Sarcoma | D012509 | — | — | — | 1 | — | — | — | 1 |
Show 10 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 2 | 2 |
| Drug interactions | D004347 | — | — | — | — | — | — | 1 | 1 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | — | — | 1 | 1 |
| Gastrointestinal diseases | D005767 | — | — | — | — | — | — | 1 | 1 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | — | — | — | 1 | 1 |
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | — | — | — | — | 1 | 1 |
| Nasopharyngeal carcinoma | D000077274 | — | — | — | — | — | — | 1 | 1 |
| Breakthrough pain | D059390 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Doxepin |
| INN | doxepin |
| Description | Doxepin is a medication belonging to the tricyclic antidepressant (TCA) class of drugs used to treat major depressive disorder, anxiety disorders, chronic hives, and insomnia. For hives it is a less preferred alternative to antihistamines. It has a mild to moderate benefit for sleeping problems. It is used as a cream for itchiness due to atopic dermatitis or lichen simplex chronicus.
|
| Classification | Small molecule |
| Drug class | tricyclic compounds |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN(C)CCC=C1c2ccccc2COc2ccccc21 |
Identifiers
| PDB | — |
| CAS-ID | 1668-19-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1628227 |
| ChEBI ID | 4710 |
| PubChem CID | 3158 |
| DrugBank | DB01142 |
| UNII ID | 5ASJ6HUZ7D (ChemIDplus, GSRS) |
Target
Agency Approved
SLC6A4
SLC6A4
SLC6A2
SLC6A2
Organism
Homo sapiens
Gene name
SLC6A4
Gene synonyms
HTT, SERT
NCBI Gene ID
Protein name
sodium-dependent serotonin transporter
Protein synonyms
5-hydroxytryptamine (serotonin) transporter, 5HT transporter, 5HTT, Na+/Cl- dependent serotonin transporter, serotonin transporter 1, solute carrier family 6 (neurotransmitter transporter), member 4, solute carrier family 6 (neurotransmitter transporter, serotonin), member 4, Solute carrier family 6 member 4
Uniprot ID
Mouse ortholog
Slc6a4 (15567)
sodium-dependent serotonin transporter (Q60857)
Variants
No data
Financial
Revenue by drug
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Estimated US medical usage
Doxepin
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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,453 documents
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Safety
Black-box Warning
Black-box warning for: Doxepin hcl, Doxepin hydrochloride
Adverse Events
Top Adverse Reactions
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5,916 adverse events reported
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