PROSOM
LOE ApproachingNDAORALTABLET
Approved
Dec 1990
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
2/8 — Basic
Drug data last refreshed 2d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROSOM is an oral small-molecule tablet approved in 1990 for insomnia and multiple sleep-related and neuropsychiatric indications including REM Sleep Behavior Disorder, anxiety, depression, and neurodegenerative diseases. The mechanism of action is not specified in available data, but the broad indication portfolio suggests CNS activity. Patients range from those with primary sleep disorders to those with comorbid psychiatric or neurodegenerative conditions.
LOE Approaching
As a legacy product approaching loss of exclusivity, PROSOM faces declining market relevance; the brand team is likely contracting or transitioning to generic support and niche indication management.
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.
Clinical Trials (1)
Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia
Started Nov 2025
100 enrolled
Chronic InsomniaSleep DeprivationREM Behavior Disorder+34 more
Career Relevance
Worked on PROSOM at Abbott? Share your interview experience or compensation data (+7 days Pro)
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.