Triazolam

Triazolam is a 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.

• Triazolam tablets are indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. Triazolam tablets are a benzodiazepine indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults.ICD-10: G47.00

• Triazolam is contraindicated in: Patients with known hypersensitivity to triazolam, any of component of triazolam, or other benzodiazepines. Reactions consistent with angioedema (involving the tongue, glottis, or larynx), dyspnea, and throat closing have been reported and may be fatal.contraindicated

Adults: Recommended dosage is 0.25 mg once daily before bedtime. Maximum recommended dosage is 0.5 mg once daily ( 2.1 ) Geriatric patients: Reduce starting dosage to 0.125 mg once daily. May increase to 0.25 mg if no response. Geriatric patients should not exceed 0.25 mg once daily ( 2.2 , 8.5 ) Triazolam should not be prescribed in quantities exceeding a 1-month supply ( 2.1 ) 2.1 Dosing Information The recommended dosage is 0.25 mg once daily before bedtime. A dosage of 0.125 mg once daily may be sufficient for some patients (e.g., patients with low body weight). A dosage of 0.5 mg should be used only for patients who do not respond adequately to a trial of a lower dose. The maximum recommended dosage is 0.5 mg once daily. Use the lowest effective dose for the patient as there are significant dose related adverse reactions. Use of triazolam for more than 3 weeks requires evaluation of the patient for a primary psychiatric or medical condition [see Warnings and Precautions ( 5.4 , 5.6 )] . Prescriptions for triazolam should be written for short-term use (7 to 10 days) and it should not be prescribed in quantities exceeding a 1-month supply. 2.2 Use in Geriatric Patients In geriatric patients, the recommended dosage is 0.125 mg to 0.25 mg once daily. Initiate therapy at 0.125 mg once daily. The 0.25 mg dose should be used only for patients who do not respond to a trial of the lower dose. The maximum recommended dosage is 0.25 mg once daily. Elderly patients have an increased risk of dose related adverse reactions [see Use in Specific Populations ( 8.5 )] .

Persistent or Worsening Insomnia : Since sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. ( 5.4 ) "Sleep-driving" and Other Complex Behaviors : Complex behaviors such as "sleep-driving" have been reported. The use of alcohol and other central nervous system (CNS) depressants with sedative-hypnotics appears to increase the risk, as well as doses exceeding the maximum recommended dose. ( 5.5 ) CNS Manifestations: An increase in daytime anxiety, abnormal thinking, and behavioral changes have been reported. Emergence of any new behavioral changes require careful and immediate evaluation. ( 5.6 ) Effects on Driving and Operating Heavy Machinery: Patients receiving triazolam should be cautioned against driving or operating heavy machinery, as well as avoiding concomitant use with alcohol and other CNS depressant drugs. ( 5.7 ) Patients with Depression: Caution should be exercised in patients with signs or symptoms of depression that could be intensified by hypnotic drugs. Prescribe the least number of tablets feasible to avoid intentional overdose. ( 5.9 ) Neonatal Sedation and Withdrawal Syndrome : Triazolam use during pregnancy can result in neonatal sedation and/or neonatal withdrawal.

The following serious adverse reactions are discussed in greater detail in other sections: Risks from Concomitant Use with Opioids [see Warnings and Precautions ( 5.1 )] Abuse, Misuse, and Addiction [see Warnings and Precautions ( 5.2 )] Dependence and Withdrawal Reactions [see Warnings and Precautions ( 5.3 )] Persistent or Worsening Insomnia [see Warnings and Precautions ( 5.4 )] "Sleep-driving" and Other Complex Behaviors [see Warnings and Precautions ( 5.5 )] Central Nervous System Manifestations [see Warnings and Precautions ( 5.6 )] Effects on Driving and Operating Heavy Machinery [see Warnings and Precautions ( 5.7 )] Patients with Depression [see Warnings and Precautions ( 5.9 )] Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions ( 5.10 )] Compromised Respiratory Function [see Warnings and Precautions ( 5.11 )] Most common adverse reactions (incidence ≥4% and twice placebo) are drowsiness, dizziness, light-headedness, and coordination disorder/ataxia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Lactation : A lactating woman may pump and discard breast milk during treatment and for 28 hours after triazolam administration ( 8.2 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including triazolam, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/. Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see Warnings and Precautions ( 5.10 ) and Clinical Considerations ]. Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Metabolism

Absorption Peak plasma levels of triazolam are reached within 2 hours following oral administration. Following recommended doses of triazolam, triazolam peak plasma levels in the range of 1 to 6 ng/mL are seen.

Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement and talkativeness) may occur. In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal [see Warnings and Precautions ( 5.2 )]. Markedly abnormal (lowered or elevated) blood pressure, heart rate or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage. In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway management.

• Nov 15, 1982NDANDA017892Pfizer
• Oct 20, 2020ANDAANDA214219Ingenus Pharms Llc
• Dec 28, 2022ANDAANDA213003Zydus Pharms

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Halcion, Tablet, .25 mg (NDC 0009-0017-58)To be discontinued
  Sponsor: Pfizer Inc.
  Updated Sep 29, 2025

1. 1Drug Abuse5256.1%
2. 2Drug Ineffective4525.3%
3. 3Sopor4024.7%
4. 4Overdose3544.1%
5. 5Nausea3524.1%
6. 6Fall3183.7%
7. 7Insomnia3053.6%
8. 8Suicide Attempt3043.5%
9. 9Pyrexia3023.5%
10. 10Diarrhoea2923.4%
11. 11Dizziness2833.3%
12. 12Somnolence2803.3%
13. 13Malaise2673.1%
14. 14Loss Of Consciousness2633.1%
15. 15Headache2623.1%

Recent PubMed references pinned to Triazolam as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Arylacetamide deacetylase deficiency potentiates ketoconazole-induced inhibition of triazolam metabolism in mice.
  Drug metabolism and pharmacokinetics · 2026 · Otsuka Y, Nagaoka M, Watanabe M, et al.
  PMID 42068797DOI 10.1016/j.dmpk.2026.101529
• Impact of electrostatic distribution in CYP3A4 on the regioselectivity of triazolam metabolism and regulation of its metabolic rate by the iron spin states: Insights from MD simulations and QM calculations.
  Journal of inorganic biochemistry · 2026 · Zhao Y, Ma X, Zheng Q, et al.
  PMID 41317564DOI 10.1016/j.jinorgbio.2025.113162
• Appropriate use of triazolam in elderly patients considering a quantitative benefit-risk assessment based on the pharmacokinetic-pharmacodynamic modeling and simulation approach supported by real-world data.
  BMC pharmacology & toxicology · 2024 · Okada A, Sera S, Nagai N, et al.
  PMID 39228002DOI 10.1186/s40360-024-00777-z
• Induction of hepatic CYP3A4 expression by cholesterol and cholic acid: Alterations of gene expression, microsomal activity, and pharmacokinetics.
  Pharmacology research & perspectives · 2024 · Minegishi G, Kobayashi Y, Fujikura M, et al.
  PMID 38644590DOI 10.1002/prp2.1197
• Treatment Failure and Long-Term Prescription Risk for Guideline-Recommended Hypnotics in Japan.
  JAMA network open · 2024 · Takeshima M, Yoshizawa K, Ogasawara M, et al.
  PMID 38630476DOI 10.1001/jamanetworkopen.2024.6865
• Triazolam for Pediatric Dental Sedation: A Retrospective Evaluation of Safety and Changes in Visit Behavior.
  Pediatric dentistry · 2024 · Yinger S, Claman D, Luca J, et al.
  PMID 38449038
• Inhibitory Actions of Antidepressants, Hypnotics, and Anxiolytics on Recombinant Human Acetylcholinesterase Activity.
  Biological & pharmaceutical bulletin · 2024 · Obara K, Mori H, Ihara S, et al.
  PMID 38296462DOI 10.1248/bpb.b23-00719
• Pharmacological treatment for central sleep apnoea in adults.
  The Cochrane database of systematic reviews · 2023 · Rocha A, Pinto ACPN, Pachito DV, et al.
  PMID 36861808DOI 10.1002/14651858.CD012922.pub2

The 10 most recently updated of 17 ClinicalTrials.gov registrations naming Triazolam as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Measurement of the Hippocampal Theta Rhythm From the Outer Ear Canal
  Recruiting · Interventional · 42 enrolled · University of Manitoba
  NCT03954483updated 2026-02-18
• A Drug-drug Interaction Study With TS-172 in Healthy Adult Male Subjects
  Completed · Phase 1 · Interventional · 30 enrolled · Taisho Pharmaceutical Co., Ltd.
  NCT06837142updated 2025-05-15
• Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
  Completed · Phase 3 · Interventional · 59 enrolled · Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
  NCT01888497updated 2021-02-21
• Oral Versus Intravenous Sedation for Ocular Procedures
  Completed · Phase 4 · Interventional · 327 enrolled · Boston Medical Center
  NCT03246724updated 2020-08-19
• Oral Sedation in Vitreoretinal Surgery
  Unknown · Phase 4 · Interventional · 80 enrolled · Rocky Vista University, LLC
  NCT04346095updated 2020-04-15
• Effects of Hallucinogens and Other Drugs on Mood and Performance
  Completed · Phase 1 · Interventional · 20 enrolled · Johns Hopkins University
  NCT02033707updated 2019-05-16
• Comparison of Triazolam and Midazolam for Anxiolysis During Dental Treatment in the Pediatric Patient
  Completed · Interventional · 4 enrolled · University of Pittsburgh
  NCT03360123updated 2018-06-19
• Pharmacovigilance in Gerontopsychiatric Patients
  Terminated · Phase 3 · Interventional · 407 enrolled · Hannover Medical School
  NCT02374567updated 2018-02-28
• Effectiveness of GABA Agonists in Reducing the Reinforcing Effects of Cocaine
  Completed · Phase 2 · Interventional · 78 enrolled · National Institute on Drug Abuse (NIDA)
  NCT00218166updated 2017-01-11
• Sensitivity of Project: EVO Monitor Cognitive Measurements to Pharmacological Agents
  Completed · Interventional · 18 enrolled · Akili Interactive Labs, Inc.
  NCT02822937updated 2016-11-07

Frequently asked questions

How does Triazolam work?

Triazolam is a 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.

What is Triazolam used for?

According to FDA labeling, Triazolam carries indications including: Triazolam tablets are indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. Triazolam tablets are a benzodiazepine indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Triazolam?

Triazolam is classified as Benzodiazepine derivatives, Benzodiazepine, GABA A Modulators, Increased Central Nervous System GABA Activity.

What are the brand names for Triazolam?

Triazolam is marketed under brand names including Halcion.

What are the contraindications for Triazolam?

Triazolam labeling lists contraindications including: Triazolam is contraindicated in: Patients with known hypersensitivity to triazolam, any of component of triazolam, or other benzodiazepines. Reactions consistent with angioedema (involving the tongue, glottis, or larynx), dyspnea, and throat closing have been reported and may be fatal.. Always consult the full prescribing information and a clinician.