Delving into the Latest Updates on Trazodone Hydrochloride with Synapse

Overview

Basic Info

SummaryTrazodone, a small molecule drug, targets the serotonin transporter and acts as a serotonin reuptake inhibitor. Although approved for treating several conditions, including major depressive disorder, diabetic neuropathies, sleep initiation and maintenance disorders, and premature ejaculation, the drug's mechanism of action remains elusive. Angelini Pharma was the first to approve the drug for use in December 1981. By increasing serotonin levels in the brain, Trazodone hydrochloride reduces symptoms of depression and improves mood. Additionally, the drug has sedative properties that make it effective in treating sleep disorders. However, Trazodone may produce unwanted side effects such as dizziness, drowsiness, and dry mouth and interact with other medications, resulting in unwanted consequences.

Drug Type

Small molecule drug

Synonyms

Oleptro, Trazodone, Trazodone HCl

+ [17]

Target

5-HT2 receptor x SERT

Action

antagonists

Mechanism

5-HT2 receptor antagonists(Serotonin 2 (5-HT2) receptor antagonists), Serotonin reuptake inhibitors

Therapeutic Areas

Nervous System DiseasesEndocrinology and Metabolic DiseaseOther Diseases+ [1]

Active Indication

Depressive Disorder, MajorDepressive DisorderDiabetic peripheral neuropathy+ [2]

Inactive Indication

Anxiety DisordersDiabetic peripheral neuropathic pain

Originator Organization

Angelini Pharma, Inc.

Active Organization

Angelini Pharma, Inc.

Kamat Pharmatech LLC

Organon & Co.

+ [5]

Inactive Organization

Pragma Pharmaceuticals LLC

Lee's Pharmaceutical Holdings Ltd.

Zhaoke Pharmaceutical (Hefei) Co., Ltd.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (24 Dec 1981),

Depressive Disorder, Major

RegulationOrphan Drug (United States)

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Structure/Sequence

Molecular FormulaC19H23Cl2N5O

InChIKeyOHHDIOKRWWOXMT-UHFFFAOYSA-N

CAS Registry25332-39-2

This study aims to evaluate how effective trazodone is in treating insomnia in adults aged 65 years and older. The main question it aims to answer is :
- Is trazodone more effective than a placebo in reducing the severity of insomnia symptoms in older adults?
Participants will :
* Take 25 to 50 mg of trazodone or a matching placebo before bed for 28 days. After a 2-week break, they will then take the other medication for another 28 days.
* Visit the clinic three times for checkup and test
* Complete a sleep diary and wear an actimeter during the night.

Start Date01 Jun 2025

Sponsor / Collaborator-

NCT05299398

/ WithdrawnPhase 1IIT

Prevention of Postpartum Depression: A Pilot Placebo-controlled Trial of Trazodone

Postpartum depression is a serious illness that affects approximately 17% of women who have recently given birth. Untreated depression appears to have negative effects for both the mother and her baby. Postpartum depression is quite common among women with a history of depression. Sleeplessness is a common concern during pregnancy and after delivery, and it can also trigger depression in women with a history of depression. Antidepressants are the most commonly recommended drugs for prevention of postpartum depression; however, there is limited research to understand the effectiveness of the medications in preventing postpartum depression. Trazodone is a weak antidepressant, but it is commonly prescribed for sleeplessness due to physical or psychiatric disorders. We are planning a study to find out whether trazodone in a low dose is more effective than a sugar pill in preventing postpartum depression among women with histories of depression. We expect the results of our study will make it easier for healthcare providers to select the right medication for women who are at risk of developing depression after delivery and thus improve the mental health of mothers and well-being of their babies.

Start Date17 Apr 2025

Sponsor / Collaborator-

CTR20250832

/ Active, not recruitingNot Applicable

盐酸曲唑酮缓释片在健康受试者中的随机、开放、两制剂、两周期、双交叉空腹及餐后生物等效性试验

[Translation] A randomized, open-label, two-dose, two-period, double-crossover bioequivalence study of trazodone hydrochloride extended-release tablets in healthy subjects under fasting and fed conditions

主要目的：以吉林天衡药业有限公司研制的盐酸曲唑酮缓释片为受试制剂，以AZ. Chim.Riun.Angelini Francesco Acraf S.P.A.持证的盐酸曲唑酮缓释片为参比制剂，按生物等效性试验的有关规定，评价两制剂在中国健康成人体内的生物等效性。次要目的：评价盐酸曲唑酮缓释片受试制剂和参比制剂（商品名：Trittico）在健康受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the two preparations in healthy Chinese adults, using the trazodone hydrochloride sustained-release tablets developed by Jilin Tianheng Pharmaceutical Co., Ltd. as the test preparation and the trazodone hydrochloride sustained-release tablets certified by AZ. Chim.Riun.Angelini Francesco Acraf S.P.A. as the reference preparation according to the relevant provisions of the bioequivalence test. Secondary objective: To evaluate the safety of the test preparation and reference preparation of trazodone hydrochloride sustained-release tablets (trade name: Trittico) in healthy subjects.

Start Date29 Mar 2025

Sponsor / Collaborator

Jilin Tianheng Pharmaceutical Co., Ltd.

100 Clinical Results associated with Trazodone Hydrochloride

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100 Translational Medicine associated with Trazodone Hydrochloride

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100 Patents (Medical) associated with Trazodone Hydrochloride

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4,068

Literatures (Medical) associated with Trazodone Hydrochloride

01 Sep 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Evaluating the carcinogenic potential of trazodone hydrochloride via duplex DNA targeting: Molecular interaction, binding mechanism and affinity assessment via structural calculations

Article

Author: Singh, Shweta ; Ali, Mohd Sajid ; Rani, Majji Sai Sudha ; Singh, Pratik ; Gopi, Priyanka ; Sharma, Palak ; Pandya, Prateek

Trazodone Hydrochloride (TRZ) is a selective serotonin antagonist reuptake inhibitor (SARI) antidepressant that is widely prescribed to treat depression. In this study, we have observed that TRZ disturbs the duplex DNA structure around the binding site causing base flip in the major groove and disrupting sequence readout. TRZ binds in the minor groove, yet it disturbs the DNA structure significantly, causing problems in sequence readout. Therefore, it would be interesting to investigate the interaction between duplex DNA. DNA binding study was conducted using multi-spectroscopic methods coupled with molecular simulations. Fluorescence investigations revealed a static quenching mechanism between TRZ and CT-DNA with a moderate binding strength (2.7 ×10⁴ LM^-1 at 288 K, 1.1 ×10⁴ LM^-1 at 298 K, 5.2 ×10³ LM^-1 at 308 K). The thermodynamic parameters suggested that the complexation was spontaneous, enthalpy-driven (-69.006 kJ/mol), with an entropy of -0.168 kJ/mol and Gibbs free energy ranging between -18.93 to -16.03 kJ/mol. Complexation was primarily facilitated by the formation of hydrogen bonds and Van der Waals forces which corroborated by the MM/PBSA findings. Detailed assessment of the binding mode and interaction mechanism through Molecular Docking and Molecular Dynamics Simulations (150 ns) indicated TRZ's affinity for the minor groove of CT-DNA which was further validated experimentally through displacement study with the known minor groove binder, DAPI. CD spectroscopy of CT-DNA in the absence and presence of TRZ revealed minor variations in the negative and positive bands indicative of groove binding. The structural variations of TRZ observed during binding indicated minor conformational adjustments and repositioning, especially at piperazine and chlorophenyl ring, providing stable interactions in the form of stacking forces leading to better fit within the binding site, particularly within the AT region of the CT-DNA's minor groove. The findings from this study will enhance our understanding of the interaction between TRZ and CT-DNA, adding depth to existing knowledge in the field.

01 Jul 2025·PSYCHIATRY RESEARCH

Non-hallucinogenic psychedelics for mood and anxiety disorders: A systematic review

Review

Author: Chen, Margery J Q ; Mansur, Rodrigo B ; Di Vincenzo, Joshua D ; Phan, Lee ; Johnson, Danica ; Chisamore, Noah ; McIntyre, Roger S ; Rosenblat, Joshua D ; Chen-Li, David ; Husain, M Ishrat

Psychedelics have re-emerged as promising treatments for mood disorders. The current model provides a moderate-to-high dose of a psychedelic agent (e.g., psilocybin) to reliably induce an altered state of consciousness. Unfortunately, the hallucinatory effects limit the treatment's potential scalability given patients' vulnerability and extensive monitoring costs, leading to growing interest in non-hallucinatory psychedelics (NHPs). This review's objective was to identify, summarize and synthesize all published pre-clinical and clinical studies evaluating NHPs for mood and anxiety disorders. We included five animal studies demonstrating antidepressant-like effects through assessments like forced swim test (FST) and open field test (OFT) without observing head-twitch response (HTR), and one case report that identified a patient who inadvertently combined trazodone and psilocybin and experienced potent antidepressant effects without psychedelic effects. These preliminary findings provide a strong impetus for further investigation in human samples with rigorously designed clinical trials that may delineate the potential antidepressant effects of psychedelics without hallucinatory effects.

04 May 2025·Expert Opinion On Drug Safety

Compartment syndrome associations with drugs: a pharmacovigilance study of the FDA adverse event reporting system (FAERS)

Article

Author: Yang, Xueting ; Shu, Yunfeng ; Tang, Juan ; Kong, Wenqiang ; Wan, Jie

BACKGROUND:

Compartment syndrome is an uncommon but life-threatening condition. No study has comprehensively compared compartment syndrome (CS) association with available drugs. The objective of this study was to estimate the association between CS and drugs using the FDA Adverse Event Report System (FAERS).

RESEARCH DESIGN AND METHODS:

FAERS reports from the first quarter of 2004 to the third quarter of 2023 were analyzed. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify CS cases. Reporting odds ratio (ROR), corresponding to 95% confidence intervals (95% CI) were calculated to detect a positive signal.

RESULTS:

A total of 2197 reports were considered in the study after the inclusion criteria were applied. Totally 100 drugs were found to be associated with CS. The median time for drug-associated CS was 45 days.

CONCLUSIONS:

By analyzing the FAERS database, the study revealed that certain drugs are significantly associated with compartment syndrome. Further studies are needed to verify whether these drugs are associated with such a risk.

19

News (Medical) associated with Trazodone Hydrochloride

19 Nov 2024

·www.businesswire.com

AgelessRx Enters Sleep Health Category, Underscoring Critical Role Sleep Plays in Healthspan and Lifespan

ANN ARBOR, Mich.--( BUSINESS WIRE )-- AgelessRx , a pioneer in longevity and telehealth solutions, today announced its entry into the sleep health category , building on its commitment to redefine aging and improve quality of life. With a strong emphasis on research-backed solutions, AgelessRx’s sleep program provides personalized sleep treatment plans, and two new products–prescription Trazodone and natural, over-the-counter (OTC) Tran-Q Sleep Supplement–alongside easy-to-adopt lifestyle recommendations. Guided by the latest scientific insights into sleep health, AgelessRx sleep regimens are effective, tailored to customers’ unique needs, and integrated into holistic, personalized treatment plans focused on extending lifespan and enhancing healthspan. Quality sleep is the cornerstone of cognitive and physical health, reducing the risk of chronic conditions like heart disease, diabetes, and obesity, which are linked to shorter lifespans. 1 in 3 Americans report sub-optimal sleep with the demands and distractions of modern lifestyles frequently deprioritizing rest and undermining sleep. AgelessRx’s tailored sleep solutions address this growing health crisis and are part of its ongoing mission to support the most important aspects of proactive healthcare. "Advances in research and understanding of sleep architecture underscores the importance of sleep as a major determinant of health and longevity—it’s our health insurance,” said Dr. Sajad Zalzala, co-founder and chief medical officer of AgelessRx. “The negative impacts of poor sleep outweigh any positive contributions proper diet and adequate exercise can offer. Our goal is to ensure this critical function is a core part of everyone's longevity routine.” Trazodone and Tran-Q Sleep AgelessRx’s new offerings are oral, non-habit forming interventions that support all four pillars of sleep: quantity, quality, regularity, and timing. Trazodone is a prescription medication with well-researched use as a safe, effective sleep aid and Tran-Q Sleep is a natural, melatonin-free OTC supplement designed for relaxation and sleep support. AgelessRx’s clinical team thoroughly reviews every patient’s medical history, unique needs, and health goals to determine the appropriate treatment for each individual. Together, these options serve a broad range of needs for people seeking improved sleep quality and sleep architecture—the process by which we cycle through different sleep stages. Trazodone (Rx): Studies show that Trazodone is effective at improving sleep onset and reducing nighttime awakenings and that Trazodone lowers the volume of three key neurochemical systems associated with waking: serotonin, histamine, and noradrenaline. Trazodone is recognized as a well-tolerated long-term intervention that has few side effects, boosting deep sleep without impacting rapid eye movement (REM) sleep, and minimizing next-day drowsiness. Tran-Q Sleep (OTC): Formulated with all-natural herbal ingredients, including passionflower and lavender, Tran-Q Sleep enhances the calming neurotransmitter (GABA) signaling and relaxes muscles while counter-balancing an overstimulated nervous system to gently prepare the mind and body for restful sleep. As a non-prescription option, Tran-Q Sleep caters to those seeking a natural solution for sleep improvement. For additional information about AgelessRx and its sleep products and services, please visit agelessrx.com . About AgelessRx AgelessRx is at the forefront of the longevity revolution, offering clinically validated cutting-edge solutions and preventive treatments aimed at extending life expectancy and enhancing quality of life. AgelessRx also continues to advance the field of longevity science by conducting ongoing research and clinical trials . Through its online platform, AgelessRx provides easy access to innovative healthcare services, with an emphasis on customer satisfaction, affordability, and the pursuit of a future where extended healthspan is a reality for everyone. Follow AgelessRx on Instagram , X , and Facebook .

11 Aug 2024

·www.pharmaindustrial-india.com

Granules India Gets ANDA Approval for Trazodone Tablets

Granules India has announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Trazodone Hydrochloride Tablets USP, 50 mg, 100 mg, 150 mg, and 300 mg. It is bioequivalent and therapeutically equivalent to the reference listed drug, Desyrel Tablets, 50 mg, 100 mg, 150 mg, and 300 mg, of Pragma Pharmaceuticals, LLC. Trazodone tablets are indicated for the treatment of major depressive disorder in adults. Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India Ltd., said, “We have received the approval within 10 months of filing the application, which is a testament to our strong R&D capabilities. The product will be launched within this quarter and the market share will grow steadily over the next few quarters.” Granules now has 65 ANDA approvals from the US FDA (64 final approvals and 1 tentative approval). The current annual U.S. market for Trazodone tablets is approximately USD 128 Million. Granules India Ltd. is a vertically integrated fast-growing Indian pharmaceutical company headquartered in Hyderabad with best-in-class facilities and a commitment to operational excellence, quality, and customer service. The company is among the few pharmaceutical companies in the world to be present in the manufacturing of the entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs). Their products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, the US, and the UK.

Drug Approval

09 Aug 2024

·pharma.economictimes.indiatimes.com

Granules India receives US FDA's ANDA approval for Trazodone Hydrochloride Tablets USP, 50 mg, 100 mg, 150 mg, 300 mg

Hyderabad: Granules India Limited announced that the US Food & Drug Administration ( US FDA ) has approved its abbreviated new drug application (ANDA) for Trazodone Hydrochloride Tablets USP , 50 mg, 100 mg, 150 mg, and 300 mg. It is bioequivalent and therapeutically equivalent to the reference listed drug, Desyrel Tablets, 50 mg, 100 mg, 150 mg, and 300 mg, of Pragma Pharmaceuticals, LLC. Trazodone tablets are indicated for the treatment of major depressive disorder in adults. Dr Krishna Prasad Chigurupati , Chairman and Managing Director, Granules India Limited, said, “The product will be launched within this quarter and the market share will grow steadily over the next few quarters.” The current annual US market for Trazodone tablets is approximately $128 million, according to MAT Jun 2024, IQVIA/IMS Health. By Online Bureau ,

Drug Approval

100 Deals associated with Trazodone Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D00820	Trazodone Hydrochloride	N06AX05	DB00656

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Depressive Disorder	Japan	Pfizer Japan, Inc.	28 Jun 1991
Depressive Disorder	Japan	Organon & Co.	28 Jun 1991
Depressive Disorder, Major	United States	Pragma Pharmaceuticals LLC	24 Dec 1981

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic peripheral neuropathic pain	Phase 2	Czechia	Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. - SpA	16 May 2017
Diabetic peripheral neuropathic pain	Phase 2	Hungary	Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. - SpA	16 May 2017
Diabetic peripheral neuropathic pain	Phase 2	Poland	Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. - SpA	16 May 2017
Diabetic peripheral neuropathy	Phase 2	China	Shenyang Funing Pharmaceutical Co Ltd.	09 May 2017
Sleep Initiation and Maintenance Disorders	Phase 2	China	Shenyang Funing Pharmaceutical Co Ltd.	19 Oct 2015
Premature Ejaculation	Phase 1	China	Shenyang Funing Pharmaceutical Co Ltd.	17 Jun 2015
Anxiety Disorders	Phase 1	China	Zhaoke Pharmaceutical (Hefei) Co., Ltd.	10 Nov 2011
Anxiety Disorders	Phase 1	China	Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. - SpA	10 Nov 2011

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04468776 (COZI, CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders	155	Zolpidem+Trazodone (Medication (Zolpidem or Trazodone))	ujdzxfnxkv(swebbhfawn) = sivxakonjp lfrsmambeb (cvaktqhxsy, udanwwmnpd - xpnrvcgemt) View more	-	24 Feb 2025
				Internet Cognitive Behavioral Therapy for Insomnia (CBT-I) (Internet Cognitive Behavioral Therapy for Insomnia (CBT-I))	ujdzxfnxkv(swebbhfawn) = rmrzrximqi lfrsmambeb (cvaktqhxsy, rbdeodkzaj - juhfzwmssw) View more
ESH2024	Not Applicable	Hypertension	123	Trazodone users	lqnhvoisrg(blfrhfxpjg) = wgajtheeei bfonebooen (vkzxzpqgiz ) View more	Negative	01 May 2024
				Non-Trazodone users	lqnhvoisrg(blfrhfxpjg) = iovlpncerp bfonebooen (vkzxzpqgiz ) View more
NCT03534284 (Sleep-HD, CTgov)	Phase 3	Sleep Initiation and Maintenance Disorders \| Kidney Failure, Chronic	126	Cognitive Behavioral Therapy for Insomnia (CBT-I)	ubcxiedwji(rblsxnyjli) = xdzekhrlel ujjbseqgvl (igxwgjdyro, fijhgquzxo - qkvpxlnbis) View more	-	05 Feb 2024
				Trazodone (Medication- Trazodone)	ubcxiedwji(rblsxnyjli) = tmlwrtvqdm ujjbseqgvl (igxwgjdyro, bcxrqfbaxh - flswuptstx) View more
ISC2024	Not Applicable	Acute Ischemic Stroke	-	SSRI/SNRI	ykwtzwzwrg(xftgbhrcqt): RR = 1.29 (95% CI, 1.11 - 1.5)	-	01 Feb 2024
				Dual Antiplatelet Therapy (DAPT)
ISC2024	Not Applicable	Hemorrhagic stroke	-	Selective Serotonin/Serotonin & Norepinephrine Reuptake Inhibitors (SSRI/SNRI)	slztwaayrp(sdrrjdcoid): RR = 1.33 (95% CI, 1.22 - 1.45)	Negative	01 Feb 2024
				Serotonergic Antidepressants (No AD)
WSC2023	Not Applicable	REM Sleep Behavior Disorder	-	Trazodone 50mg	fmtyzcynvl(fbpifiqglp) = yftxjdeagp jrvpjrtrfk (gusqogamfu )	-	23 Oct 2023
WSC2023	Not Applicable	Sleep Initiation and Maintenance Disorders	716	Lemborexant	qthvfbieqm(lbkqjfkvle) = frdqkqpjvm celscnimlp (nqescfypjv )	Positive	23 Oct 2023
				Trazodone	qthvfbieqm(lbkqjfkvle) = noryvbrxwp celscnimlp (nqescfypjv )
NCT04162743 (Pubmed \| J Neurol)	Phase 4	Ischemic stroke	22	Trazodone 100 mg	urtaxkqjxp(vcnsmyiaqm) = ufzmyogwhg vqzyvcdbjp (kxsahyqbal ) View more	-	24 Feb 2021
				Placebo	urtaxkqjxp(vcnsmyiaqm) = nvvfpbqjgk vqzyvcdbjp (kxsahyqbal ) View more
NCT01348542 (Pubmed \| J Clin Sleep Med)	Not Applicable	Sleep Wake Disorders	15	Trazodone	fjalwlrenl(fhdfedccks) = xjjsczfygl uyhcuqhcau (iwasugondc ) View more	-	15 Dec 2020
				Cognitive-Behavioral Therapy for Insomnia (CBT-I)	fjalwlrenl(fhdfedccks) = shopnmyxpk uyhcuqhcau (iwasugondc ) View more
NCT03202979 (Pubmed \| CNS Drugs)	Phase 2	Diabetic Neuropathies	142	TRZ30	cpxtjlyytt(ekicqeaxnp) = No serious adverse event occurred during the trial and the most frequent treatment-emergent adverse events involved nervous system, QT prolongation, and gastrointestinal disorders qftulugiqj (kzelpfbpnn )	-	01 Nov 2020
				TRZ60