DOXEPIN HYDROCHLORIDE
Doxepin tablets are used for patients who struggle with insomnia, specifically those who have trouble staying asleep throughout the night. This medication helps patients with sleep maintenance issues to improve the quality of their rest. It is typically prescribed for durations of up to three months based on clinical evidence.
How DOXEPIN HYDROCHLORIDE Works
While the exact way this drug works to maintain sleep is not fully understood, its effects are likely produced by targeting the H1 receptor. By acting as an antagonist at this site, the medication helps patients stay asleep.
Details
- Status
- Prescription
- First Approved
- 1972-01-31
- Routes
- ORAL, TOPICAL
- Dosage Forms
- TABLET, CAPSULE, CREAM, CONCENTRATE
Companies
DOXEPIN HYDROCHLORIDE Approval History
What DOXEPIN HYDROCHLORIDE Treats
1 indicationsDOXEPIN HYDROCHLORIDE is approved for 1 conditions since its original approval in 1972. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Insomnia
DOXEPIN HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to DOXEPIN HYDROCHLORIDE
3 of 17FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02062632 results posted | MC13C1 NCI-2014-00253, MC13C1 | Ph 2 | terminated | Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy |
| NCT01156142 results posted | NCCTG-N09C6 NCI-2011-02049, CDR0000675520 | Ph 3 | completed | Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DOXEPIN HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)DOXEPIN HYDROCHLORIDE is indicated for the treatment of Insomnia.
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SILENOR
Full clinical data, patents, trials, and competitive landscape for doxepin hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.