NDAORALTABLET
Approved
Oct 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
1/8 — Limited
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
UNISOM (doxylamine succinate) is an oral first-generation antihistamine approved as an over-the-counter sleep aid for short-term insomnia. It works by blocking histamine receptors in the central nervous system to promote sedation. The product has been on the market since 1978 and remains a recognized brand in the OTC sleep category.
LOE Approaching
As an OTC product approaching loss of exclusivity with moderate competitive pressure (30%), brand teams face declining market share and shifting focus toward cost management and retention strategies.
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 exposure to OTC brand management, consumer marketing, and retail channel dynamics, but limited career growth due to the product's mature lifecycle and approaching or realized loss of exclusivity. Roles emphasize efficiency, cost control, and defensive market strategy rather than innovation or launch momentum.
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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.