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 insomnia characterized by difficulty with sleep maintenance, insomnia characterized by difficulties with sleep maintenance. First approved in 2010.
Drug data last refreshed 9h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SILENOR (doxepin HCl) is an oral small-molecule tablet approved in 2010 for insomnia characterized by sleep maintenance difficulties. It works primarily through H1 receptor antagonism, though its exact mechanism in sleep maintenance remains incompletely understood. The drug represents a repurposing of doxepin, a tricyclic antidepressant, at sub-therapeutic doses for a specific sleep disorder indication.
$0.907MPart D
PeakStable
4.2 years to LOEProduct is in peak lifecycle stage with modest Medicare Part D penetration (~1,351 claims in 2023); team size likely stable with focus on market maintenance and competitive positioning.
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.