NDAORALTABLETPriority Review
Approved
Nov 1982
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
5/8 — Partial
Priority ReviewSchedule 4
HALCION (triazolam) by Pfizer is benzodiazepine. First approved in 1982.
Drug data last refreshed 13h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HALCION (triazolam) is a short-acting benzodiazepine approved in 1982 for the short-term treatment of insomnia. It works by binding to GABA-A receptors in the brain and enhancing GABAergic synaptic inhibition to promote sleep. The drug is a small-molecule oral tablet indicated for insomnia, though safety data show significant abuse and overdose signals.
$42,000Part D
LOE ApproachingDeclining
Declining utilization and LOE-approaching status signal a mature, contracted franchise with limited growth opportunities and lean team structures.
Mechanism of Action
benzodiazepine. Triazolam exerts its effect for the short-term treatment of insomnia through binding to the benzodiazepine site of the gamma-aminobutyric acid-A (GABA A ) receptors in the brain and enhances GABA-mediated synaptic inhibition.
Pharmacologic Class:
Benzodiazepine
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
Started Jul 2013
59 enrolled
Healthy
A Study to Determine Whether an Oral Drops Formulation of Triazolam is Bioequivalent to a Tablet Formulation in Healthy Subjects
Started Sep 2011
34 enrolled
Healthy
Triazolam Trial In Healthy Subjects To Compare Bioavailability Between Formulations Of Triazolam To Determine Their Bioequivalence In Terms Of Rate And Magnitude Of Absorption
Started Aug 2010
0Healthy Volunteers
A Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTab™ in Patients Undergoing an Elective Abdominal Liposuction Procedure
Started Jun 2009
40 enrolled
SedationAnxietyPain
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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.