Doxylamine
Bonjesta, Diclegis, Unisom (doxylamine) is a small molecule pharmaceutical. Doxylamine was first approved as Unisom on 1982-01-01. It is used to treat allergic rhinitis perennial, headache, and sleep initiation and maintenance disorders in the USA.
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Commercial
Trade Name
FDA
EMA
Unisom (generic drugs available since 1996-09-18, discontinued: Decapryn, Doxy-sleep-aid)
CombinationsBonjesta, Diclegis (generic drugs available since 1996-09-18, discontinued: Bendectin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Doxylamine succinate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
UNISOM | Sanofi | N-018066 OTC | 1982-01-01 | 1 products, RLD, RS |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
bonjesta | New Drug Application | 2021-12-21 |
diclegis | New Drug Application | 2021-12-17 |
doxylamine succinate and pyridoxine hydrochloride | NDA authorized generic | 2023-06-15 |
unisom sleeptabs | ANDA | 2023-04-26 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
allergic rhinitis perennial | EFO_1001417 | D012221 | J30.89 |
headache | HP_0002315 | D006261 | R51 |
sleep initiation and maintenance disorders | — | D007319 | F51.01 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
17 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 | 1 | 1 | — | 1 | — | 3 | |
Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | 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 | |
Dementia | D003704 | F03 | — | — | 1 | — | — | 1 | |
Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | 1 | — | — | 1 |
Depression | D003863 | F33.9 | — | — | 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 |
Mucositis | D052016 | EFO_1001898 | — | — | 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 |
---|---|---|---|---|---|---|---|---|---|
Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 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 | |
Sarcoma | D012509 | — | 1 | — | — | — | 1 | ||
Lymphoma | D008223 | C85.9 | — | 1 | — | — | — | 1 | |
Small cell lung carcinoma | D055752 | — | 1 | — | — | — | 1 | ||
Thymoma | D013945 | — | 1 | — | — | — | 1 | ||
Mesothelioma | D008654 | C45 | — | 1 | — | — | — | 1 |
Show 4 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 |
---|---|---|---|---|---|---|---|---|---|
Pruritus | D011537 | HP_0000989 | L29 | — | — | — | — | 3 | 3 |
Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | — | — | 1 | 1 |
Gastrointestinal diseases | D005767 | — | — | — | — | 1 | 1 | ||
Dyspepsia | D004415 | EFO_0008533 | K30 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | DOXYLAMINE |
INN | doxylamine |
Description | Doxylamine is a member of pyridines and a tertiary amine. It has a role as a histamine antagonist, a cholinergic antagonist, a sedative, an antiemetic, a H1-receptor antagonist, an anti-allergic agent and an antitussive. |
Classification | Small molecule |
Drug class | — |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | CN(C)CCOC(C)(c1ccccc1)c1ccccn1 |
Identifiers
PDB | — |
CAS-ID | 469-21-6 |
RxCUI | — |
ChEMBL ID | CHEMBL1004 |
ChEBI ID | 51380 |
PubChem CID | 3162 |
DrugBank | DB00366 |
UNII ID | 95QB77JKPL (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,021 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,438 adverse events reported
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