NDAORALCAPSULE
Approved
Feb 1981
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
Drug data last refreshed 3h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RESTORIL (temazepam) is an oral benzodiazepine capsule approved in 1981 for the short-term treatment of insomnia. It works by enhancing GABAergic neurotransmission in the central nervous system to promote sleep initiation and maintenance.
$0.984MPart D
LOE ApproachingDeclining
Product is in mature/declining phase with modest Part D utilization (686 claims in 2023); commercial teams are transitioning to maintenance mode or wind-down activities.
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 career opportunities center on data analytics, customer relationship management, and financial optimization rather than commercial field expansion. These roles reflect the product's transition from growth management to operational efficiency and managed decline.
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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.