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] |
Target |
Action inhibitors |
Mechanism NET inhibitors(Norepinephrine transporter inhibitors), Serotonin reuptake inhibitors |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active 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) |
Molecular FormulaC20H24ClN |
InChIKeyKFYRPLNVJVHZGT-UHFFFAOYSA-N |
CAS Registry549-18-8 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D00809 | Amitriptyline Hydrochloride |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Erythromelalgia | Phase 2 | United States | 14 Jun 2023 | |
| Erythromelalgia | Phase 2 | Germany | 14 Jun 2023 | |
| Pain | Phase 2 | Germany | 14 Jun 2023 | |
| Neoplasms | Phase 2 | United States | 28 Feb 2023 | |
| Neoplasms | Phase 2 | Belgium | 28 Feb 2023 | |
| Neoplasms | Phase 2 | Czechia | 28 Feb 2023 | |
| Neoplasms | Phase 2 | France | 28 Feb 2023 | |
| Neoplasms | Phase 2 | Italy | 28 Feb 2023 | |
| Neoplasms | Phase 2 | Poland | 28 Feb 2023 | |
| Neoplasms | Phase 2 | Spain | 28 Feb 2023 |
Phase 3 | 271 | (1 - Amitriptyline) | mykjrvzhfz(wdsekcahdl) = zcwjhrgkrz gfcsdpzawn (zfxmizybcm, qvvrjhtnob - tlqxbzpvoa) View more | - | 07 Oct 2025 | ||
Placebo (2 - Placebo) | mykjrvzhfz(wdsekcahdl) = iobntbcmos gfcsdpzawn (zfxmizybcm, cftmwdlxvx - cqvixnqjsx) View more | ||||||
NCT05593614 (Biospace) Manual | Phase 2 | - | uziksrxcza(udshybfemx) = drgfniprca zmnghqtibl (akjvoqezkq ) View more | Negative | 18 Mar 2025 | ||
Placebo | - | ||||||
Not Applicable | - | - | kvpedirywh(kvuicxvnya) = 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) gwcfvsemfw (gwwsrgrsss ) | - | 15 Oct 2023 | ||
Placebo | |||||||
Phase 4 | 10 | SPG Block with 5% Lidocaine gel+Amitriptyline (Amitriptyline / Elavil) | nzgqrlabjj(yrlgkvpwyb) = qrahkagtou wetlsrrxno (gnecxfrtxf, 0.5) View more | - | 29 Dec 2021 | ||
SPG Block with 5% Lidocaine gel+Amitriptyline (SPG Nerve Block With Lidocaine 5% Gel) | nzgqrlabjj(yrlgkvpwyb) = llbenhlfhr wetlsrrxno (gnecxfrtxf, 10.4) View more | ||||||
Phase 2/3 | 6 | (Amitriptyline) | kzwdnqcmxf(nfvmyoxoqz) = oceykfhbkz cahivwqspi (zoxlzhqrrq, 1.41) View more | - | 29 Oct 2021 | ||
Placebo (Placebo) | kzwdnqcmxf(nfvmyoxoqz) = zmhcfkklan cahivwqspi (zoxlzhqrrq, 2.08) View more | ||||||
Not Applicable | - | 194 | qybvsbdxvr(qqnrcenzsi) = prmzmzaufp ruilvyknly (ouapudevtx ) View more | Positive | 01 Oct 2020 | ||
Placebo | qybvsbdxvr(qqnrcenzsi) = qrsqbhhotx ruilvyknly (ouapudevtx ) View more | ||||||
Phase 2 | 2 | (Amitriptyline) | meefrhqqze(dtdiglpevm) = qnzumjnoqz vytmeyyacn (ojnwmvpjib, wbktkcwlzd - nzlreuwkxg) View more | - | 22 Jul 2019 | ||
Placebo (Placebo) | meefrhqqze(dtdiglpevm) = pipcckjwjz vytmeyyacn (ojnwmvpjib, rrgstsykml - gcmkgqjwpd) View more | ||||||
Phase 2 | 13 | (Topical KeAmLi Combo) | yzabdglllm(gioxvqespn) = nnytzfalbg jwtfvtpsdh (zhrqqjjxfj, 29.00397851) View more | - | 02 Jul 2019 | ||
(Topical Ketamine) | yzabdglllm(gioxvqespn) = ypdftesdyz jwtfvtpsdh (zhrqqjjxfj, 30.11218341) View more | ||||||
Not Applicable | - | neqjzxuwyn(qalvoxnnbi) = gcicijmitx xtdhvrzndj (sjcydkmlay ) | - | 01 Oct 2018 | |||
Flupenthixol melitracen | neqjzxuwyn(qalvoxnnbi) = czqybdzdzw xtdhvrzndj (sjcydkmlay ) | ||||||
Phase 2 | 50 | (Amitriptyline Immediate) | sgpqrcfibr = rvkbbgkktj rfupdknasr (ovtjkyhepx, rqmmrehgqs - vhywtgfqua) View more | - | 22 Dec 2017 | ||
(Amitriptyline Delayed) | sgpqrcfibr = idcbnygjbf rfupdknasr (ovtjkyhepx, lqmuudmhmr - byfjrlfnrs) View more |





