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DOXEPIN HYDROCHLORIDE
Doxepin may help maintain sleep by blocking H1 receptors.
Doxepin Hydrochloride is a marketed drug primarily indicated for insomnia with sleep maintenance difficulty. Its key strength lies in its mechanism of action, which helps maintain sleep by blocking H1 receptors. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | DOXEPIN HYDROCHLORIDE |
|---|---|
| Target | H1 receptor |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1969 |
Mechanism of action
The exact way doxepin helps with sleep maintenance is not fully understood, but it is thought that its effects might be due to blocking H1 receptors, which are involved in regulating sleep.
Approved indications
- Insomnia with sleep maintenance difficulty
Common side effects
- Somnolence/Sedation
- Somnolence/Sedation
- Upper Respiratory Tract Infection/Nasopharyngitis
- Gastroenteritis
- Nausea
- Nausea
- Hypertension
Drug interactions
- MAO inhibitors
- Cimetidine
- Alcohol
- CNS Depressants and Sedating Antihistamines
- Tolazamide
Key clinical trials
- Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy (PHASE3)
- Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma (NA)
- Characterization of the Toll-like Receptor 7-agonist Imiquimod 3.75% As a New Surrogate Model of Itch (NA)
- Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
- Stigma and Efficacy of Zhizhu Kuanzhong Capsules (NA)
- Characterization of New Human Models of Non-histaminergic Itch and Their Interaction With the TRPM8 Receptor (NA)
- Using Doxepin for Urticaria (PHASE3)
- Characterization of BAM8-22 as a New Surrogate Model of Non-histaminergic Itch (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- DOXEPIN HYDROCHLORIDE CI brief — competitive landscape report
- DOXEPIN HYDROCHLORIDE updates RSS · CI watch RSS