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 Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DALMANE (flurazepam hydrochloride) is a 1,4-benzodiazepine oral capsule approved in 1970 for the treatment of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. The drug works by binding to stereo-specific receptors at multiple CNS sites, though its exact mechanism remains unknown. Flurazepam is rapidly absorbed and metabolized, with active metabolites that accumulate over consecutive nights, making it increasingly effective with repeated dosing.
LOE Approaching
Product is approaching loss of exclusivity with modest competitive pressure (30 relative score), signaling shrinking brand team resources and transition toward generic management.
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.