Last update 27 Aug 2025

Amitriptyline Hydrochloride

Overview

Basic Info

SummaryAmitriptyline Hydrochloride, a small molecule drug, is a reuptake inhibitor targets the monoamine transporters. Developed by Merck and first approved on April 7th, 1961, the drug is used to treat a range of conditions such as neuralgia, depressive disorder, and nocturnal enuresis. The drug works by preventing the reuptake of neurotransmitters, particularly serotonin and norepinephrine, which can lead to an increase in their concentration in the brain and subsequently enhance mood. Amitriptyline Hydrochloride is available in the form of oral tablets, which should only be used under the strict guidance of a healthcare provider. Patients must be aware of potential side effects such as dry mouth, constipation, and drowsiness, which can manifest in some individuals. The drug's administration should be closely monitored and individualized to ensure its safe and effective use. In conclusion, while Amitriptyline Hydrochloride presents an effective medication for managing certain neurological and mood disorders, patients must exercise caution and adhere to the recommended usage guidelines.
Drug Type
Small molecule drug
Synonyms
10,11-dihydro-5-(γ-dimethylaminopropylidene)-5H-dibenzo(a,d)cycloheptene, 10,11-dihydro-N,N-dimethyl-5H-dibenzo(a,d)heptalene-Δ5,γ-propylamine, 3-(10,11-dihydro-5H-dibenzo(a,d)cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine
+ [25]
Action
inhibitors
Mechanism
NET inhibitors(Norepinephrine transporter inhibitors), Serotonin reuptake inhibitors
Inactive Indication
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (07 Apr 1961),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

Molecular FormulaC20H24ClN
InChIKeyKFYRPLNVJVHZGT-UHFFFAOYSA-N
CAS Registry549-18-8

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Neuralgia
Japan
29 Feb 2016
Depressive Disorder
Japan
02 Nov 1961
Nocturnal Enuresis
Japan
02 Nov 1961
Bipolar Disorder
United States
07 Apr 1961
Depressive Disorder, Major
United States
07 Apr 1961
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
ErythromelalgiaPhase 2
United States
14 Jun 2023
ErythromelalgiaPhase 2
Germany
14 Jun 2023
PainPhase 2
Germany
14 Jun 2023
NeoplasmsPhase 2
United States
28 Feb 2023
NeoplasmsPhase 2
Belgium
28 Feb 2023
NeoplasmsPhase 2
Czechia
28 Feb 2023
NeoplasmsPhase 2
France
28 Feb 2023
NeoplasmsPhase 2
Italy
28 Feb 2023
NeoplasmsPhase 2
Poland
28 Feb 2023
NeoplasmsPhase 2
Spain
28 Feb 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
-
hfbgcijlly(oppcdddctr) = oignxlifbf zfjywogzrw (qtxotrwyzn )
Negative
18 Mar 2025
Placebo
-
Not Applicable
-
-
ihrdfbiaow(ljqjjtfehh) = 46 (19.8%) patients discontinued amitriptyline (30 (12.9%) adverse events) and 59 discontinued placebo (25.5%) (20 (8.7%) adverse events). There were 5 serious adverse reactions (2 amitriptyline, 3 placebo) awpginmpir (gpanmmvhgi )
-
15 Oct 2023
Placebo
Phase 4
10
SPG Block with 5% Lidocaine gel+Amitriptyline
(Amitriptyline / Elavil)
dooyxgqomg(twnlinxxju) = uqeglcsqwh znizjlvfds (bgfwueafil, 0.5)
-
29 Dec 2021
SPG Block with 5% Lidocaine gel+Amitriptyline
(SPG Nerve Block With Lidocaine 5% Gel)
dooyxgqomg(twnlinxxju) = hofqntzdzc znizjlvfds (bgfwueafil, 10.4)
Phase 2/3
6
(Amitriptyline)
wkbsotlvbm(tusotpmkdy) = egzmhbvfll rzlsseoenw (bleogwdfwn, 1.41)
-
29 Oct 2021
Placebo
(Placebo)
wkbsotlvbm(tusotpmkdy) = yaprgkgjvz rzlsseoenw (bleogwdfwn, 2.08)
Not Applicable
-
194
tteicdmoox(fdullrguul) = qnnbjsctws kaiuskdqcc (favpnhfmzm )
Positive
01 Oct 2020
Placebo
tteicdmoox(fdullrguul) = zxbfezjazk kaiuskdqcc (favpnhfmzm )
Phase 2
2
(Amitriptyline)
tmtpazvicv(owccmbcifp) = pmigkounhc pnrqqdinfx (nutnpnubkt, dklkhcqypr - tjtjthhpic)
-
22 Jul 2019
Placebo
(Placebo)
tmtpazvicv(owccmbcifp) = ytrzlbtigt pnrqqdinfx (nutnpnubkt, lqakrncjfl - kaylkdvaga)
Phase 2
13
koakaqcepd(bvtamevbyg) = wlmzkjomqq ckpmktqshz (zxfcxknzpq, 29.00397851)
-
02 Jul 2019
(Topical Ketamine)
koakaqcepd(bvtamevbyg) = vpvusltheu ckpmktqshz (zxfcxknzpq, 30.11218341)
Not Applicable
-
syqmkfdeys(wbhwzuqlmw) = xwjpndzwaj racclnxnwo (zwgpnbwons )
-
01 Oct 2018
Flupenthixol melitracen
syqmkfdeys(wbhwzuqlmw) = dzatzfjqmp racclnxnwo (zwgpnbwons )
Phase 2
50
(Amitriptyline Immediate)
vbetjdpcnd = ostmjgeczq hsprhxdlil (jzwmfzoerr, trdytvuepi - lukictkwtt)
-
22 Dec 2017
(Amitriptyline Delayed)
vbetjdpcnd = ytymfxeuig hsprhxdlil (jzwmfzoerr, jnicyuvznf - volfyjckcc)
Phase 3
488
(Topiramate)
cevsloddwd = jxmhmzlyoa omstjktxft (zbblzdnrbm, oxjfudscnd - nibcmnflgy)
-
10 Aug 2017
Placebo
(Placebo)
cevsloddwd = rrlnbtmigh omstjktxft (zbblzdnrbm, wlyayzmtvf - fokqffilwg)
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