HALCION®, CIV Highlights

(triazolam)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use HALCION safely and effectively. See full prescribing information for HALCION.

HALCION (triazolam) tablets, for oral use, CIV
Initial U.S. Approval: 1982

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS

See full prescribing information for complete boxed warning.

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. Follow patients for signs and symptoms of respiratory depression and sedation (5.1, 7.1).
The use of benzodiazepines, including Halcion, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing Halcion and throughout treatment, assess each patient's risk for abuse, misuse, and addiction (5.2).
Abrupt discontinuation or rapid dosage reduction of Halcion after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Halcion or reduce the dosage (2.3, 5.3).

RECENT MAJOR CHANGES

Warnings and Precautions (5.10)

1/2023

INDICATIONS AND USAGE

Halcion is a benzodiazepine indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. (1)

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)
Halcion should not be prescribed in quantities exceeding a 1-month supply (2.1)

DOSAGE FORMS AND STRENGTHS

Scored tablets: 0.25 mg (3)

CONTRAINDICATIONS

Known hypersensitivity to Halcion 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)

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. (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: Halcion use during pregnancy can result in neonatal sedation and/or neonatal withdrawal. (5.10, 8.1)

ADVERSE REACTIONS

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 Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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)

USE IN SPECIFIC POPULATIONS

Lactation: A lactating woman may pump and discard breast milk during treatment and for 28 hours after HALCION administration (8.2)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 1/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use HALCION safely and effectively. See full prescribing information for HALCION.

HALCION (triazolam) tablets, for oral use, CIV
Initial U.S. Approval: 1982

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS

See full prescribing information for complete boxed warning.

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. Follow patients for signs and symptoms of respiratory depression and sedation (5.1, 7.1).
The use of benzodiazepines, including Halcion, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing Halcion and throughout treatment, assess each patient's risk for abuse, misuse, and addiction (5.2).
Abrupt discontinuation or rapid dosage reduction of Halcion after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Halcion or reduce the dosage (2.3, 5.3).

RECENT MAJOR CHANGES

Warnings and Precautions (5.10)

1/2023

INDICATIONS AND USAGE

Halcion is a benzodiazepine indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. (1)

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)
Halcion should not be prescribed in quantities exceeding a 1-month supply (2.1)

DOSAGE FORMS AND STRENGTHS

Scored tablets: 0.25 mg (3)

CONTRAINDICATIONS

Known hypersensitivity to Halcion 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)

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. (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: Halcion use during pregnancy can result in neonatal sedation and/or neonatal withdrawal. (5.10, 8.1)

ADVERSE REACTIONS

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 Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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)

USE IN SPECIFIC POPULATIONS

Lactation: A lactating woman may pump and discard breast milk during treatment and for 28 hours after HALCION administration (8.2)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 1/2023

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