TRIAZOLAM
Triazolam is a medication used for adults who have trouble sleeping. It helps patients with insomnia on a short-term basis, typically for a period of seven to ten days. This benzodiazepine is prescribed to provide temporary relief for sleep disturbances.
How TRIAZOLAM Works
This drug works by binding to specific benzodiazepine sites on GABA-A receptors within the brain. Once attached, it enhances the inhibitory effects of GABA at the synapses. This increased neural inhibition helps produce the sedative effects needed to manage sleep issues.
Details
- Status
- Discontinued
- First Approved
- 1994-03-25
- Routes
- ORAL
- Dosage Forms
- TABLET
TRIAZOLAM Approval History
What TRIAZOLAM Treats
1 indicationsTRIAZOLAM is approved for 1 conditions since its original approval in 1994. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Insomnia
TRIAZOLAM Boxed Warning
RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation [see Warnings and Precau...
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 )]. The use of benzodiazepines, including triazolam, exposes users to risks of abuse, misuse and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing triazolam and throughout treatment, assess each patient's risk for abuse, misuse and addiction [see Warnings and Precautions ( 5.2 )]. The continued use of benzodiazepines, including triazolam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of triazolam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue triazolama or reduce the dosage [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.3 )]. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS See full prescribing information for complete boxed warning . Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatmen
TRIAZOLAM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to TRIAZOLAM
3 of 17FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01888497 results posted | A9451178 | Ph 3 | completed | Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers |
| NCT03246724 results posted | H-36590 | Ph 4 | completed | Oral Versus Intravenous Sedation for Ocular Procedures |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT01017926 | A6781002 | Ph 1 | withdrawn | Triazolam Trial In Healthy Subjects To Compare Bioavailability Between Formulations Of Triazolam To Determine Their Bioequivalence In Terms Of Rate And Magnitude Of Absorption |
| NCT01780259 | CR100942 ESKETINTRD1001, 2012-004374-25 | Ph 1 | completed | A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Participants |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TRIAZOLAM FDA Label Details
Indications & Usage
TRIAZOLAM is indicated for the treatment of Insomnia.
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients f...
Looking for the branded version?
HALCION
Full clinical data, patents, trials, and competitive landscape for triazolam.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.