Triazolam: uses, dosing, side effects & brands

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 Viatris at 1-877-446-3679 (1-877-4-INFO-RX) 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…

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. • Concomitant administration of strong cytochrome P450 (CYP 3A) enzyme inhibitors (e.g., ketoconazole, itraconazole, nefazodone, lopinavir, ritonavir) [see Warnings and Precautions (5.8) , Drug Interactions (7.1) ]. • Known hypersensitivity to triazolam or other benzodiazepines ( 4 ) • Concomitant use with medications that significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP 3A) including ketoconazole, itraconazole, nefazodone, and several human immunodeficiency virus (HIV) protease inhibitors ( 4 , 5.8 , 17 )

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. Benzodiazepines interact at GABA A sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Prevention or management Limit dosage and duration of concomitant use of triazolam and opioids, and monitor patients closely for respiratory depression and sedation [see Warnings and Precautions (5.1) ] . CNS Depressants Clinical implication Triazolam produces additive CNS depressant effects when co-administered with other CNS depressants. Prevention or management Limit dosage and duration of triazolam during concomitant use with CNS depressants. Strong Inhibitors of CYP 3A Clinical implication Concomitant use of triazolam with strong CYP3A inhibitors has a profound effect on the clearance of triazolam, resulting in increased concentrations of triazolam and increased risk of adverse reactions [see Clinical Pharmacology (12.3) ]. Prevention or management Do not administer triazolam with a strong CYP3A4 inhibitor [see Contraindications (4) , Warnings and Precautions (5.8) ]. Moderate and Weak Inhibitors of CYP 3A Clinical implication Concomitant use of triazolam with moderate or weak inhibitors of CYP3A inhibitors may increase the concentrations of triazolam, resulting in increased risk of adverse reactions [see Clinical Pharmacology (12.3) ]. Prevention or management Use with caution and consider appropriate dose reduction of triazolam when coadministered with moderate and weak CYP3A inhibitors [see Warnings and Precautions (5.8) ]. Strong Inducers of CYP 3A Clinical implication Coadministration of triazolam with strong inducers of CYP3A4 can significantly decrease the plasma concentration of triazolam and may decrease effectiveness of triazolam. Prevention or management Caution is recommended during coadministration of triazolam with strong inducers of CYP3A4. Interactions Based on Experience with Other Benzodiazepines or in vitro Studies with Triazolam Clinical implication Available data from clinical studies of benzodiazepines other than triazolam, from in vitro studies with triazolam, or from in vitro studies with benzodiazepines other than triazolam suggest a possible drug interaction with triazolam [see Clinical Pharmacology (12.3) ]. Prevention or management Caution is recommended during coadministration of triazolam with any of these drugs. [see Warnings and Precautions (5.8) ].