NDAORALTABLET
Approved
Oct 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
1/8 — Limited
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
UNISOM (doxylamine succinate) is an over-the-counter antihistamine indicated for short-term relief of occasional sleeplessness. It works as a first-generation H1 receptor antagonist with sedating properties, widely used in self-care sleep aid formulations. The product has been on the market since 1978 and remains a staple in the OTC sleep category.
LOE Approaching
As an aging OTC asset approaching loss of exclusivity, the brand team is likely focused on lifecycle management, private label competition, and line extension rather than growth investment.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on UNISOM offers limited career growth potential given its mature lifecycle stage and approaching LOE. Roles are primarily defensive—focused on cost containment, private label management, and portfolio optimization rather than innovation or commercial expansion.
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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.