NDAORALTABLET
Approved
Mar 2010
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
2
Data completeness
6/8 — Strong
SILENOR (doxepin hydrochloride) by Currax Pharmaceuticals is 12. Approved for oral mucositis, head and neck cancer, pain. First approved in 2010.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SILENOR (doxepin hydrochloride) is an oral small-molecule tablet approved in 2010 for sleep maintenance, with off-label use in oral mucositis, head and neck cancer pain, and general pain management. The mechanism of action in sleep maintenance is unclear but is thought to be mediated through H1 receptor antagonism. It represents a repurposing of a tricyclic antidepressant at low doses for insomnia.
$0.9MPart D
Peak4.3 years to LOESILENOR is in peak lifecycle with modest Part D penetration ($907K in 2023), suggesting a stable but niche commercial franchise with limited team expansion opportunities.
Mechanism of Action
12.1. Mechanism of Action The mechanism of action of doxepin in sleep maintenance is unclear; however, doxepin's effect could be mediated through antagonism of the H 1 receptor .
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.