Triazolam

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.

• Adults: Recommended dosage is 0.25 mg once daily before bedtime
• Maximum recommended dosage is 0.5 mg once daily 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 Triazolam should not be prescribed in quantities exceeding a 1-month supply 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 ]
• 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
• 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

Triazolam Tablets USP, 0.125 mg are white to off-white, elliptical tablet, plain on one side and debossed with "1521" on other side of tablet. Triazolam Tablets USP, 0.25 mg are light-grayish blue, elliptical, mottled, scored tablet, plain on one side and debossed with "12" and "89" on either side of scoreline. Tablets: 0.125 mg, 0.25 mg (Scored) ( 3 )

• Safety and effectiveness of triazolam have not been established
• In pediatric patients

Elderly patients exhibit higher plasma triazolam concentrations due to reduced clearance as compared with younger subjects at the same dose. Because elderly patients are especially susceptible to dose related adverse reactions and to minimize oversedation, the smallest effective dose should be used [see Dosage and Administration ( 2.2 ), Clinical Pharmacology ( 12.3 )] .

• Advise the patient to read the FDA-approved patient labeling (Medication Guide)
• Risks from Concomitant Use with Opioids Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when triazolam is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider
• Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined [see Warnings and Precautions , Drug Interactions ] . …

• 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. …

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. …

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 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 )] Neo …

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/. …

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. …

9.1 Controlled Substance Triazolam tablets contain triazolam, a Schedule IV controlled substance. 9.2 Abuse Triazolam is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.