NDAORALCAPSULEPriority Review
Approved
Apr 1970
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
DALMANE (flurazepam hydrochloride) by Bausch + Lomb is 12. Approved for insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings and 1 more indications. First approved in 1970.
Drug data last refreshed 23h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Dalmane (flurazepam hydrochloride) is a benzodiazepine hypnotic approved in 1970 that treats insomnia characterized by difficulty falling asleep, nocturnal awakenings, and early morning awakenings. It works by binding to stereo-specific CNS receptors, with rapid absorption and metabolism yielding active metabolites with extended half-lives (47-100 hours) that accumulate over consecutive nights.
LOE Approaching
Product approaching loss of exclusivity with minimal competitive pressure (30%), signaling potential contraction of brand and support team resources.
Mechanism of Action
12.1 Mechanism of Action Flurazepam, like other central nervous system agents of the 1,4-benzodiazepine class, presumably exerts its effects by binding to stereo-specific receptors at several sites within the central nervous system (CNS). The exact mechanism of action is unknown. 12.3…
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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.