Triazolam
Generic Name: triazolam
Brand Names:
Triazolam
11 DESCRIPTION Triazolam is a triazolobenzodiazepine. Triazolam is a white crystalline powder, soluble in alcohol and poorly soluble in water. It has a molecular weight of 343.21. The chemical name for triazolam is 8-chloro-6-(o-chlorophenyl)-1-methyl-4H-s-triazolo-[4,3-α] [1,4] benzodiazepine. The structural formula is represented below: Each triazolam tablet, for oral administration, contains 0.125 mg or 0.25 mg of triazolam.
Overview
11 DESCRIPTION Triazolam is a triazolobenzodiazepine. Triazolam is a white crystalline powder, soluble in alcohol and poorly soluble in water. It has a molecular weight of 343.21. The chemical name for triazolam is 8-chloro-6-(o-chlorophenyl)-1-methyl-4H-s-triazolo-[4,3-α] [1,4] benzodiazepine. The structural formula is represented below: Each triazolam tablet, for oral administration, contains 0.125 mg or 0.25 mg of triazolam.
Uses
1 INDICATIONS AND USAGE Triazolam is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. Triazolam is a benzodiazepine indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION • 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.
Side Effects
6 ADVERSE REACTIONS 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 (...
Interactions
7 DRUG INTERACTIONS • Use with Opioids : Increase the risk of respiratory depression ( 7.1 ) • Use with Other CNS Depressants : Produces additive CNS depressant effects ( 7.1 ) • Use with CYP 3A4 Inhibitors : Increased risk of adverse reactions ( 4 , 5.8 , 7.1 ) 7.1 Drugs Having Clinically Important Interactions With Triazolam Table 2 includes clinically significant drug interactions with triazolam [see Clinical Pharmacology (12.3) ] . Table 2: Clinically Important Drug Interactions with Triazolam Opioids Clinical implication The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration.
Warnings
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. 5 WARNINGS AND PRECAUTIONS • 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. 4 CONTRAINDICATIONS 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.
Pregnancy
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/ .
Storage
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] .
Frequently Asked Questions
What is Triazolam used for?▼
1 INDICATIONS AND USAGE Triazolam is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. Triazolam is a benzodiazepine indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. ( 1 )
What are the side effects of Triazolam?▼
6 ADVERSE REACTIONS 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 (...
Can I take Triazolam during pregnancy?▼
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/ .
What are the important warnings for Triazolam?▼
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. 5 WARNINGS AND PRECAUTIONS • 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. 4 CONTRAINDICATIONS 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.