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AboutPricing
Drug ReportsDoxylamine
Doxylamine
Bonjesta, Diclegis, Doxylamine, 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
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
nervous system diseasesD009422
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
mental disordersD001523
Trade Name
FDA
EMA
Doxylamine, Unisom (discontinued: Decapryn, Doxy-sleep-aid, Doxylamine, Unisom)
Combinations
Bonjesta, Diclegis, Doxylamine pyridoxine (discontinued: Bendectin, Doxylamine pyridoxine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Doxylamine succinate
+
Pyridoxine hydrochloride
Tradename
Company
Number
Date
Products
BONJESTADuchesnayN-209661 RX2016-11-07
1 products, RLD, RS
DICLEGISDuchesnayN-021876 RX2013-04-08
1 products, RLD, RS
Show 1 discontinued
Doxylamine succinate
Tradename
Company
Number
Date
Products
UNISOMSanofiN-018066 OTC1982-01-01
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
24-7 life by 7-eleven nighttime cold and fluC2002632024-11-21
acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hclOTC monograph final2017-07-19
acetaminophen dextromethorphan hydrobromide and doxylamine succinateOTC monograph not final2019-12-26
acetaminophen dextromethorphan hydrobromide doxylamine succinate phenylephrine hydrochlorideOTC monograph final2017-06-02
acetaminophen, dextromethorphan hbr and doxylamine succinateC2002632025-09-22
acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinateOTC monograph final2023-03-25
acetaminophen, dextromethorphan hydrobromide and doxylamine succinateC2002632025-03-04
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinateOTC monograph final2010-09-01
acetaminophen, dextromethorphan hydrobromide, doxylamine succinateOTC monograph final2023-03-25
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate and phenylephrine hydrochlorideC2002632025-09-22
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
headache—D006261R51
sleep initiation and maintenance disorders—D007319F51.01
allergic rhinitis perennialEFO_1001417D012221J30.89
seizures—D012640G40.4
vitamin b 6 deficiency—D026681E53.1
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Doxylamine Succinate / Pyridoxine Hydrochloride, Bonjesta, Duchesnay
90894892033-02-18DPU-1382
93754042033-02-18DPU-1382
95267032033-02-18DPU-1382
99371322033-02-18DPU-1382
ATC Codes
R: Respiratory system drugs
— R06: Antihistamines for systemic use
— R06A: Antihistamines for systemic use
— R06AA: Aminoalkyl ethers, systemic antihistamines
— R06AA09: Doxylamine
— R06AA59: Doxylamine, combinations
HCPCS
No data
Clinical
Clinical Trials
19 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NauseaD009325—R11.01—3149
VomitingD014839—R11.1——4138
Morning sicknessD048968————11—2
CoughD003371—R05———1—1
Common coldD003139EFO_0007214J00———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hyperemesis gravidarumD006939EFO_1000971O21——2—13
Covid-19D000086382—U07.1—11——1
Pregnancy complicationsD011248————1——1
PregnancyD011247EFO_0002950Z33.1——1——1
InfectionsD007239EFO_0000544———1——1
Communicable diseasesD003141————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Marfan syndromeD008382Orphanet_558Q87.4—1———1
SyndromeD013577———1———1
ArachnodactylyD054119———1———1
Colorectal neoplasmsD015179——11———1
Rectal neoplasmsD012004——11———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Oral lichen planusD017676——1————1
Lichen planusD008010—L431————1
Biological availabilityD001682——1————1
Respiratory tract infectionsD012141—J06.91————1
Allergic rhinitisD065631—J30.91————1
RhinitisD012220EFO_0008521J311————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pregnancy rateD018873——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDoxylamine
INNdoxylamine
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)Loading
Structure (InChI/SMILES or Protein Sequence)
CN(C)CCOC(C)(c1ccccc1)c1ccccn1
Identifiers
PDB—
CAS-ID469-21-6
RxCUI—
ChEMBL IDCHEMBL1004
ChEBI ID51380
PubChem CID3162
DrugBankDB00366
UNII ID95QB77JKPL (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
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Estimated US medical usage
Doxylamine
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Dextromethorphan
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Acetaminophen
Total medical expenditures per year (USD, in millions)
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Doxylamine
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Dextromethorphan
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Doxylamine
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Doxylamine
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Phenylephrine
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Doxylamine
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Pseudoephedrine
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Doxylamine
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Pyridoxine
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,111 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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7,884 adverse events reported
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