Last update 26 Jul 2026

Doxepin hydrochloride

Overview

Basic Info

SummaryDoxepin, the small molecule drug, serves as a cogent therapeutic agent, targeting both the norepinephrine transporter (NET) and serotonin transporter subtype 5 (SERT-5). Through the dual action of inhibiting the reuptake of both norepinephrine and serotonin in the brain, doxepin functions as a resplendent antidepressant, leading to an escalation in the levels of these neurotransmitters within the synaptic cleft. This neurochemical alteration helps to stabilize mood, mitigate anxiety, and augment sleep quality, thereby yielding numerous benefits. From its inception, in September 1969, doxepin has been the beacon of hope for those struggling with depression, anxiety disorders, and insomnia. Nonetheless, it is imperative to be cognizant of the fact that doxepin can induce some untoward effects, including, but not limited to, drowsiness, dry mouth, constipation, and weight gain, and may even interact with other medications. Therefore, it is judicious to utilize doxepin with due caution under the discerning guidance of a healthcare professional.
Drug Type
Small molecule drug
Synonyms
Doxepin, Doxepin hydrochloride (USP), Doxepin Hydrochloride Cream
+ [16]
Action
inhibitors
Mechanism
NET inhibitors(Norepinephrine transporter inhibitors), Serotonin reuptake inhibitors
Originator Organization
License Organization
Drug Highest PhaseApproved
First Approval Date
United States (23 Sep 1969),
Regulation-
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Structure/Sequence

Molecular FormulaC19H22ClNO
InChIKeyMHNSPTUQQIYJOT-UHFFFAOYSA-N
CAS Registry1229-29-4

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Sleep Initiation and Maintenance Disorders
United States
17 Mar 2010
Dermatitis, Atopic
United States
01 Apr 1994
Neurodermatitis
United States
01 Apr 1994
Pruritus
United States
01 Apr 1994
Anxiety Disorders
United States
23 Sep 1969
Depressive Disorder
United States
23 Sep 1969
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Head and Neck NeoplasmsPhase 3
United States
01 Dec 2010
MucositisPhase 3
United States
01 Dec 2010
Oral painPhase 3
United States
01 Dec 2010
Radiation InjuriesPhase 3
United States
01 Dec 2010
StomatitisPhase 3
United States
01 Dec 2010
Esophageal CarcinomaPhase 2
United States
14 Apr 2014
EsophagitisPhase 2
United States
14 Apr 2014
Hypopharyngeal CarcinomaPhase 2
United States
14 Apr 2014
Laryngeal NeoplasmsPhase 2
United States
14 Apr 2014
LymphomaPhase 2
United States
14 Apr 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
5
placebo
gffvqkccno = hjrxvrxebx bonboarlvy (xwnbnghvdz, fszieckfef - hnrsuvksek)
-
01 Oct 2019
Phase 3
275
kbdtuxseno(ieccqnzfhn) = wcweigdyjq gtpzjqxudc (ounycixfpy )
Positive
16 Apr 2019
Phase 4
52
(Silenor 6 mg (DXP-4H))
mbykylqfqp(scvtlqtkfa) = umlsommmtl rbhzlvqjla (ijqovrpwig, 11.8)
-
07 Dec 2017
(Placebo (PBO-4H))
mbykylqfqp(scvtlqtkfa) = donslmmwbl rbhzlvqjla (ijqovrpwig, 18.6)
Phase 3
155
Placebo+Doxepin
(Arm I (Doxepin-Placebo))
hznbkuapqt(njvyzmvqms) = mtlzzppsuw unwdihuqos (zuvjdxczlq, 7.9)
-
08 May 2017
Placebo+Doxepin
(Arm II (Placebo-Doxepin))
hznbkuapqt(njvyzmvqms) = czbdludauo unwdihuqos (zuvjdxczlq, 6.1)
Phase 3
275
(Doxepin)
tnuaoltwqk(snqtxexktl) = skaqauejqn vowhtziykb (scumpxuixm, 9.7)
-
10 Apr 2017
DLA+Lidocaine+Diphenhydramine
(DLA (Diphenhydramine, Lidocaine and Antacid))
tnuaoltwqk(snqtxexktl) = wgjdwjmpgd vowhtziykb (scumpxuixm, 8.1)
Phase 4
44
Placebo
eibqbpyzlg(rubewweznx) = uskzycfrrn jxnaizxdrl (zayelnukcb, 6.1)
-
30 Jul 2013
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