NDAORALCAPSULE
Approved
Feb 1981
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RESTORIL (temazepam) is a benzodiazepine indicated for insomnia, approved in 1981. It works by potentiating GABA-mediated chloride channel opening in the central nervous system to reduce neuronal excitability and promote sleep onset.
$0.984MPart D
LOE ApproachingDeclining
With LOE approaching and minimal Part D spending, RESTORIL brand team is in transition phase with limited growth opportunity and likely reduced headcount planning.
Mechanism of Action
Pharmacologic Class:
Benzodiazepine
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Study to Investigate the Effects of Melatonin, Temazepam & Zolpidem on Sleep EEG in Men and Women
Started Jul 2009
16 enrolled
Insomnia
Career Relevance
RESTORIL represents a legacy product with minimal career opportunity, offering limited exposure to growth, innovation, or high-impact strategic initiatives. Roles are primarily maintenance-focused with consolidation risk as the product transitions post-LOE.
Company
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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.