Delving into the Latest Updates on Doxepin hydrochloride with Synapse

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]

Target

NET x SERT

Action

inhibitors

Mechanism

NET inhibitors(Norepinephrine transporter inhibitors), Serotonin reuptake inhibitors

Therapeutic Areas

Immune System DiseasesNervous System DiseasesCongenital Disorders+ [3]

Active Indication

Sleep Initiation and Maintenance DisordersDermatitis, AtopicNeurodermatitis+ [4]

Inactive Indication

Esophageal CarcinomaEsophagitisHead and Neck Neoplasms+ [16]

Originator Organization

Pfizer Laboratories (Pty) Ltd.

Active Organization

Endo International Plc

Taicang Pharmaceutical FactoryMylan Pharmaceuticals, Inc.

+ [5]

Inactive Organization

Mayo ClinicPfizer Laboratories (Pty) Ltd.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (23 Sep 1969),

Anxiety DisordersDepressive Disorder

Regulation-

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Structure/Sequence

Molecular FormulaC19H22ClNO

InChIKeyMHNSPTUQQIYJOT-UHFFFAOYSA-N

CAS Registry1229-29-4

Relevant randomized controlled trials (RCTs) were retrieved from PubMed, Embase, Scopus, the Cochrane Library, Web of Science, and ClinicalTrials.gov from inception to April 15, 2025. The standard mean difference (SMD) was generated for consecutive variants, including the wake after sleep onset(WASO), latency to persistent sleep(LPS), total sleep time(TST), and sleep efficiency(SE), for pairwise comparisons via Bayesian network meta-regression (NMR) analyses adjusted for the follow-up period and age by RStudio 4.4.2. Pharmacovigilance (PV) was investigated by leveraging the FAERS database, and odds ratios (ORs) were generated for dichotomous and ordinal variants for pairwise comparisons via STATA 18.0 MP.

RESULT:

A total of 15 studies evaluating 10 treatment regimens involving 2408 patients were included in the final analysis. For the WASO, compared with the placebo group, dimdazenil 2.5 mg/d (SMD = -0.388, 95 % CI: -0.608 to -0.166), lemborexant 10 mg/d (SMD = -0.624, 95 % CI: -0.894 to -0.355), lemborexant 5 mg/d (SMD = -0.612, 95 % CI: -0.88 to -0.342), daridorexant 25 mg/d (SMD = -0.957, 95 % CI: -1.436 to -0.479), melatonin 6 mg/d (SMD = -0.741, 95 % CI: -1.423 to -0.044), zolpidem 10 mg/d (SMD = -0.348, 95 % CI: -0.61 to -0.068), doxepin 3 mg/d (SMD = -0.497, 95 % CI: -0.713 to -0.282) were significantly superior. Among the effective regimens, lemborexant 10 mg/d, lemborexant 5 mg/d, daridorexant 25 mg/d, melatonin 6 mg/d, and doxepin 3 mg/d were comparable. However, dimdazenil 2.5 mg/d (SMD = 0.568, 95 % CI: 0.046 to 1.096) and zolpidem 10 mg/d (SMD = 0.608, 95 % CI: 0.074 to 1.171) were significantly inferior to daridorexant 25 mg/d.After adjusting for the follow-up period, the results resembled those of the raw analysis except for the loss of significant superiority of melatonin 6 mg/d (SMD = -0.727, 95 % CI: -1.48 to 0.01) over the placebo. However, melatonin 6 mg/d demonstrated a "time window" of significant superiority over the control group from the 10^th to 40^th weeks. After adjusting for age, dimdazenil 2.5 mg/d (SMD = -0.355, 95 % CI: -0.652 to -0.1), lemborexant 10 mg/d (SMD = -0.508, 95 % CI: -0.9 to -0.114), zolpidem 10 mg/d (SMD = -0.526, 95 % CI: -0.84 to -0.158) demonstrated significant superiority over placebo. In terms of safety, with respect to nervous system disorders, safety signals were detected in suvorexant (IC₀₂₅ = 0.212; 95 % CI: 1.214 to 1.334), lemborexant (IC₀₂₅ = 0.221; 95 % CI: 1.236 to 1.567), daridorexant (IC₀₂₅ = 0.205; 95 % CI: 1.21 to 1.427) and doxepin (IC₀₂₅ = 0.066; 95 % CI: 1.091 to 1.411). In terms of dyspnoea, eszopiclone (OR ranging from 0.556 to 0.669) had significantly lower constituent ratios than daridorexant, melatonin and zolpidem did. Melatonin (OR = 1.568, 95 % CI = 1.192 to 2.061, p = 0.001) and zolpidem (OR = 1.302, 95 % CI = 1.026 to 1.653, p = 0.03) had a significantly higher constituent ratio than suvorexant. The proportion of patients with severe dyspnoea caused by daridorexant (OR = 0.256, 95 % CI = 0.096 to 0.678, p = 0.006) was significantly lower than that caused by suvorexant and lemborexant. For adverse reaction outcomes, zaleplon (OR = 9.888, 95 % CI = 1.124 to 86.944, p = 0.039) had a significantly higher effect than daridorexant on severe dyspnoea.

CONCLUSION:

Comprehensively considering the efficacy effect size, time windows (follow-up period, age, and types of insomnia), PV, severity of imperative adverse events, we propose prioritizing the use of daridorexant 25 mg/d for insomnia characterized by difficulty maintaining sleep and insufficient sleep duration. For insomnia characterized by difficulty falling asleep, we recommend prioritizing the use of lemborexant 10 mg/day or zolpidem 10 mg/day. For overall poor sleep efficiency, we recommend using lemborexant. Drug selection should be based on the types of insomnia and drug safety. More head-to-head clinical trials are needed to confirm those findings.

01 Nov 2025·SEPARATION AND PURIFICATION TECHNOLOGY

Experimental characterization and QSAR modeling of maximum uptake and distribution factor for neutral and ionic micropollutants on granular activated carbon in artificial and real wastewaters

Author: Cho, Chul-Woong ; Park, Si-Hyeon ; Lee, Kwan-Yong ; Cho, Bo-Gyeon ; Jin, Se-Ra ; Cheon, Jeong-Min

Granular activated carbon (GAC)-based adsorption treatment for micropollutant removal is known to be cost-effective and environmentally sustainable.However, an efficient method is urgently needed to assess the applicability of GAC for a diverse range of micropollutants in various wastewater conditions.Therefore, we developed predictive models to determine the maximum uptake (qmax; calculated by the Langmuir model) and distribution factor (KF; calculated by the Freundlich model) of a range of micropollutants on GAC, which can help overcome exptl. limitations, save resources and time, and provide a deeper understanding of adsorption mechanisms.Exptl. isotherms for controlled conditions to obtain the qmax and KF were performed for both artificial and real wastewaters. qmax values of micropollutants were similar in both wastewaters, but KF values differed slightly.Exptl. obtained qmax and KF values were used in linear free energy relationship-based predictive modeling.The results showed reasonable predictive accuracy for qmax, with R2 values ranging from 0.844 to 0.875 and standard errors between 0.144 and 0.072 log units for both artificial and real wastewater conditions.For KF, the model showed R2 values between 0.803 and 0.762, with standard errors ranging from 0.189 to 0.163 log units.The two models showed high potential for use in GAC-based micropollutant removal.

01 Aug 2025·Dermatology and Therapy

Urticaria Voices: Real-World Treatment Patterns and Outcomes in Chronic Spontaneous Urticaria

Article

Author: Raftery, Tara ; Saraswat, Pallavi ; Bernstein, Jonathan A ; McCarthy, Jessica ; Winders, Tonya A ; Chapman-Rothe, Nadine ; Weller, Karsten

INTRODUCTION:

Chronic spontaneous urticaria (CSU) is characterized by itchy wheals/hives and/or angioedema lasting longer than 6 weeks. Herein, we describe patients' perspectives from the global Urticaria Voices study reporting treatment patterns, disease burden, treatment satisfaction, and expectations.

METHODS:

This global, cross-sectional online survey was conducted from February to September 2022 in patients with CSU. Eligible patients had a self-reported clinician-provided diagnosis of CSU. Data were analyzed descriptively and reported as percentages (n/N), means (standard deviation [SD]), or 95% confidence intervals.

RESULTS:

Overall, 582 patients with CSU were included in this analysis (62% women; mean [SD] age: 42.0 [11.9] years). At the time of the survey, patients reported taking 2.9 (2.6) concomitant therapies; most patients (79%) were prescribed H1-antihistamines (H1-AH), of which 42% took first-generation H1-AH and 52% took second-generation H1-AH. Since the initiation of their first prescribed treatment (6.3 [8.2] years), 80% of patients reported H1-AH switching (2.3 times on average), 62% of whom reported up-dosing (2.9 times on average). In addition, 50% reported currently using glucocorticoids (cream: 72.1%; oral: 48.3%; injection: 25.5%) and 33% reported using any biologic (omalizumab: 26%; dupilumab: 16%): montelukast (18%), doxepin (16%), or ciclosporin (16%). Apart from their prescribed treatments, patients reported currently using additional services (dietetic consultations: 21%, psychological support: 19%) and self-care strategies (e.g., using topical creams, avoiding certain clothing and foods) for CSU management. Most patients (65%) reported that their current treatments did not adequately control their CSU symptoms. Overall, 37% of patients reported experiencing stress due to the unpredictable nature of the disease.

CONCLUSIONS:

Despite H1-antihistamine switching and up-dosing, most patients (84%) had inadequately controlled disease. Approximately one-quarter of inadequately controlled patients were escalated to more effective treatments such as biologics. These results suggest a need for additional treatment options for patients with inadequately controlled CSU to provide sustained symptom relief.

6

News (Medical) associated with Doxepin hydrochloride

22 Aug 2025

·www.fiercepharma.com

Fierce Pharma Asia—J&J's $2B Fujifilm deal; Drug recalls for 3 Indian firms; RemeGen, Santen's eye med pact

Johnson & Johnson's manufacturing pact with Fujifilm Biotechnologies, three Indian companies' drug recalls, and an eye disease deal between Santen Pharmaceutical and RemeGen made our news this week. Johnson & Johnson is spending part of its big U.S. investment at a Fujifilm Biotechnologies site. Three Indian drugmakers issued U.S. drug recalls in recent weeks due to impurities. Japan's Santen Pharma licensed a VEGF/FGF bispecific from RemeGen. And more.1. In US manufacturing push, J&J earmarks $2B for Fujifilm in 10-year deal in North CarolinaJohnson & Johnson has committed $2 billion over the next 10 years to secure a 160,000-plus-square-foot facility at Fujifilm Biotechnologies’ biomanufacturing campus in Holly Springs, North Carolina. The deal will create about 120 new jobs in the state, J&J said. The pact followed a $3 billion arrangement Fujifilm recently made with Regeneron.2. Alembic, Sun and Glenmark issue US drug recalls due to the presence of carcinogens or foreign matterThree Indian drugmakers—Alembic, Sun Pharma and Glenmark—have issued separate U.S. drug recalls in recent weeks. Alembic recalled 9,492 bottles of doxepin hydrochloride due to an impurity of the potential human carcinogen nitrosamine. In addition, Sun recalled 11,328 bottles of spironolactone due to the presence of aluminum, and Glenmark issued three recalls, including two covering carvedilols because of the presence of a nitrosamine.3. China's RemeGen sells Asia rights to VEGF/FGF eye drug in $180M dealJapanese eye disease specialist Santen Pharmaceutical is paying 250 million Chinese yuan ($34.8 million) for certain Asia rights to a VEGF/FGF fusion protein by China’s RemeGen. The drug, coded RC28-E, is already in phase 3 development in diabetic macular edema and wet age-related macular degeneration. The deal could eventually be worth about $180 million.4. GC’s Made Scientific opens cell therapy facility in New Jersey (release)Made Scientific, a U.S.-based cell therapy CDMO subsidiary of Korea’s GC Holdings, has opened its 60,000-square-foot facility and headquarters in Princeton, New Jersey. The opening marked the completion of a $12 million initial investment in the site. The company plans to add 12,000 square feet in additional clean room space to support late-stage and commercial programs.

Phase 3Cell Therapy

20 Aug 2025

·www.fiercepharma.com

Alembic, Sun and Glenmark issue US drug recalls due to the presence of carcinogens or foreign matter

Three Indian drugmakers issued separate U.S. drug recalls in recent weeks. A trio of Indian drugmakers—Alembic Pharmaceuticals, Sun Pharmaceutical and Glenmark Pharmaceuticals—issued separate voluntary U.S. drug recalls in recent weeks due to either the presence of carcinogens or foreign matter in the products.All of the recalls fall under the FDA’s Class II designation, which signifies that the products in question could cause temporary health issues and, in some rare cases, serious but not life-threatening problems.Alembic recalled 9,492 bottles of the antidepressant doxepin hydrochloride in 10-mg capsules due to a deviation in its manufacturing process that resulted in a nitrosamine-related impurity above the level allowed by the U.S. drug agency. The FDA disclosed the recall in a routine enforcement update.Nitrosomines are considered potential human carcinogens. The meds, which were distributed nationwide, were manufactured in the company’s facility in Gujarat, India, for the company’s U.S. branch. The recall was issued by Alembic on July 25.Meanwhile, Sun Pharma’s U.S. subsidiary based in Princeton, New Jersey, has issued a voluntary recall of 11,328 bottles of spironolactone in 25-mg tablets after it found the presence of aluminum in a finished product. Spironolactone is typically used to treat high blood pressure. The lot under the recall was manufactured for Sun by Frontida BioPharm in Philadelphia and was distributed nationwide, according to the FDA update.As for Glenmark, the company issued three separate recalls, with two of them covering more than 83,000 bottles of carvedilol tablets at various dosages. The drug is generally used to treat high blood pressure.The pair of carvedilol recalls were initiated Aug. 6 and Aug. 7 due to the presence of a nitrosamine, according to FDA records. The drugs under recall were distributed across the U.S. Two of the lots were manufactured in the company’s Madhya Pradesh facility in India, and three were produced at Glenmark’s Goa, India, plant.Glenmark also issued a separate recall Aug. 8 for 22,656 bottles of theophylline extended-release tablets at the 400-mg dose. The drug is used to treat asthma and chronic obstructive pulmonary disease.The recall was issued after a batch test failed to meet FDA dissolution and stability standards. The drugs were also produced by Glenmark in Goa and were distributed throughout the U.S.Editor's note: This story was updated at 8:10 a.m. ET on Aug. 21 to correct the stated indication of spironolactone.

14 Aug 2025

·pharma.economictimes.indiatimes.com

Alembic recalls over 9.4k bottles of antidepressant drug in US

New Delhi: Alembic Pharmaceuticals, US-arm in undertaking a voluntary recall of antidepressant drug Doxepin due to “ CGMP Deviations .” According to the US FDA latest enforcement report, the Gujarat-based drugmaker is recalling “9,492 bottles” of Doxepin Hydrochloride Capsules manufactured at its Panela-based facility. The recall is initiated due to the, “presence of a Nitrosamine Drug Substance Related Impurity (NDSRI) exceeding the proposed interim acceptable limit.” The voluntary action is classified as ‘Class II’ recall and was initiated by the company on June 25, 2025. A Class II recall is initiated for products which may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Doxepin Hydrochloride is an antidepressant drug prescribed for the treatment of depression, anxiety, bedwetting and several other indications. By Online Bureau ,

100 Deals associated with Doxepin hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D00814	Doxepin hydrochloride	N06AA12 D04AX01	DB01142

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Sleep Initiation and Maintenance Disorders	United States	Currax Pharmaceuticals LLC	17 Mar 2010
Dermatitis, Atopic	United States	Mylan Pharmaceuticals, Inc.	01 Apr 1994
Neurodermatitis	United States	Mylan Pharmaceuticals, Inc.	01 Apr 1994
Pruritus	United States	Mylan Pharmaceuticals, Inc.	01 Apr 1994
Anxiety Disorders	United States	Pfizer Laboratories (Pty) Ltd.	23 Sep 1969
Depressive Disorder	United States	Pfizer Laboratories (Pty) Ltd.	23 Sep 1969

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Head and Neck Neoplasms	Phase 3	United States	Alliance Foundation Trials LLC	01 Dec 2010
Mucositis	Phase 3	United States	Alliance Foundation Trials LLC	01 Dec 2010
Oral pain	Phase 3	United States	Alliance Foundation Trials LLC	01 Dec 2010
Radiation Injuries	Phase 3	United States	Alliance Foundation Trials LLC	01 Dec 2010
Stomatitis	Phase 3	United States	Alliance Foundation Trials LLC	01 Dec 2010
Esophageal Carcinoma	Phase 2	United States	Mayo Clinic	14 Apr 2014
Esophagitis	Phase 2	United States	Mayo Clinic	14 Apr 2014
Hypopharyngeal Carcinoma	Phase 2	United States	Mayo Clinic	14 Apr 2014
Laryngeal Neoplasms	Phase 2	United States	Mayo Clinic	14 Apr 2014
Lymphoma	Phase 2	United States	Mayo Clinic	14 Apr 2014

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02062632 (CTgov)	Phase 2	Sarcoma \| Hypopharyngeal Carcinoma \| Pleural Neoplasms ... View more	5	placebo	usrvgjfhfu = kcfrkaxnrk uphfazkajh (delevzbpcd, bnliorotzy - gkvefqyhgd) View more	-	01 Oct 2019
NCT02229539 (Alliance A221304, Pubmed \| JAMA)	Phase 3	radiation oral mucositis	275	Doxepin Mouthwash	fstrvmtgla(nxdejuiwee) = mmdqrrkseg qzhsfyydlf (fyedzebmqv ) View more	Positive	16 Apr 2019
NCT01156142 (CTgov)	Phase 3	Pain \| Radiation Injuries \| Mucositis ... View more	155	Placebo+Doxepin (Arm I (Doxepin-Placebo))	qptuvqmkyi(cushtjobnu) = lujmfrhzld hphjiveemp (pbifdooart, 7.9) View more	-	08 May 2017
NCT01156142 (CTgov)	Phase 3	Pain \| Radiation Injuries \| Mucositis ... View more	155	Placebo+Doxepin (Arm II (Placebo-Doxepin))	qptuvqmkyi(cushtjobnu) = bkdhisffwr hphjiveemp (pbifdooart, 6.1) View more	-	08 May 2017
NCT02229539 (Alliance A221304, CTgov)	Phase 3	Stomatitis	275	Doxepin (Doxepin)	hkhavjpljv(uchzlmenst) = xszqwuifrg enwecxenba (wroonzlrnm, 9.7) View more	-	10 Apr 2017
NCT02229539 (Alliance A221304, CTgov)	Phase 3	Stomatitis	275	DLA+Lidocaine+Diphenhydramine (DLA (Diphenhydramine, Lidocaine and Antacid))	hkhavjpljv(uchzlmenst) = sdulghoagv enwecxenba (wroonzlrnm, 8.1) View more	-	10 Apr 2017
NCT00465972 (CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders \| HIV Infections	44	Placebo	fmaxxwvwnx(oceinhefio) = rkoxpegusr tmcqwawvtm (pjeeyttyjk, 6.1) View more	-	30 Jul 2013