Triazolam

Overview

Withdrawn in the United Kingdom due to risk of psychiatric adverse drug reactions. This drug continues to be available in the U.S. Internationally, triazolam is a Schedule IV drug under the Convention on Psychotropic Substances.

Indication

For the short-term treatment of insomnia.

Associated Conditions

Insomnia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Measurement of the Hippocampal Theta Rhythm From the Outer Ear Canal	2019/05/17	NCT03954483	Not Applicable	Recruiting	University of Manitoba
Comparison of Triazolam and Midazolam for Anxiolysis During Dental Treatment in the Pediatric Patient	2017/12/02	NCT03360123	Not Applicable	Completed	University of Pittsburgh
Oral Versus Intravenous Sedation for Ocular Procedures	2017/08/11	NCT03246724	Phase 4	Completed	Boston Medical Center
Sensitivity of Project: EVO Monitor Cognitive Measurements to Pharmacological Agents	2016/07/06	NCT02822937	Not Applicable	Completed	Akili Interactive Labs, Inc.
Pharmacovigilance in Gerontopsychiatric Patients	2015/03/02	NCT02374567	Phase 3	Terminated	Hannover Medical School
Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers	2013/06/27	NCT01888497	Phase 3	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Participants	2013/01/31	NCT01780259	Phase 1	Completed	Janssen Research & Development, LLC
A Study to Determine Whether an Oral Drops Formulation of Triazolam is Bioequivalent to a Tablet Formulation in Healthy Subjects	2011/08/22	NCT01421043	Phase 1	Completed	Pfizer
Triazolam Trial In Healthy Subjects To Compare Bioavailability Between Formulations Of Triazolam To Determine Their Bioequivalence In Terms Of Rate And Magnitude Of Absorption	2009/11/23	NCT01017926	Phase 1	Withdrawn	Pfizer

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Triazolam	Rebel Distributors Corp	21695-284	ORAL	0.25 mg in 1 1	7/15/2009
Triazolam	Zydus Lifesciences Limited	70771-1576	ORAL	0.125 mg in 1 1	9/28/2023
Triazolam	Aphena Pharma Solutions - Tennessee, LLC	43353-451	ORAL	0.25 mg in 1 1	11/16/2017
Triazolam	Ingenus Pharmaceuticals, LLC	50742-645	ORAL	0.125 mg in 1 1	10/30/2020
Triazolam	A-S Medication Solutions	50090-4733	ORAL	0.25 mg in 1 1	5/8/2018
Triazolam	PD-Rx Pharmaceuticals, Inc.	43063-996	ORAL	0.25 mg in 1 1	7/14/2023
Triazolam	Rebel Distributors Corp	21695-303	ORAL	0.125 mg in 1 1	7/15/2009
Triazolam	Hikma Pharmaceuticals USA Inc.	0054-4859	ORAL	0.25 mg in 1 1	3/8/2024
TRIAZOLAM	STAT RX USA LLC	16590-236	ORAL	0.25 mg in 1 1	6/3/2010
Triazolam	Unit Dose Services	50436-3718	ORAL	0.25 mg in 1 1	8/16/2017

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Triazolam Tablets 0.125 mg bottle	135792	Alphapharm Pty Ltd	Medicine	A	3/2/2007
Triazolam Tablets 0.25 mg bottle	135793	Alphapharm Pty Ltd	Medicine	A	3/2/2007

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
NOVO-TRIOLAM TAB 0.25MG	novopharm limited	00872431	Tablet - Oral	.25 MG	12/31/1990
PENTA-TRIAZOLAM TABLETS	pentapharm ltd.	02232553	Tablet - Oral	.125 MG / TAB	N/A
TRIAZOLAM	aa pharma inc	00808571	Tablet - Oral	0.25 MG	12/31/1989
TRIAZOLAM TABLETS 0.125MG	prempharm inc	02230024	Tablet - Oral	0.125 MG	1/3/1997
TRIAZOLAM	aa pharma inc	00808563	Tablet - Oral	0.125 MG	12/31/1989
ALTI-TRIAZOLAM TAB 0.125MG	altimed pharma inc.	00614351	Tablet - Oral	.125 MG / TAB	12/31/1987
PENTA-TRIAZOLAM TABLETS	pentapharm ltd.	02232554	Tablet - Oral	.25 MG / TAB	N/A
MYLAN-TRIAZOLAM	Mylan Pharmaceuticals ULC	01913506	Tablet - Oral	0.25 MG	12/31/1992
ALTI-TRIAZOLAM TAB 0.25MG	altimed pharma inc.	00614378	Tablet - Oral	.25 MG / TAB	12/31/1987
MYLAN-TRIAZOLAM	Mylan Pharmaceuticals ULC	01995227	Tablet - Oral	0.125 MG	12/31/1992

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
HALCION 0,125 mg COMPRIMIDOS	Pfizer S.L.	58118	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Psicótropos	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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