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

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Adults: Recommended dosage is 0.25 mg once daily before bedtime. Maximum recommended dosage is 0.5 mg once daily (2.1)

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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)

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

Scored tablets: 0.25 mg (3)

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Known hypersensitivity to Halcion or other benzodiazepines (4)

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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)

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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)

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"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)

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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)

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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)

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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)

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

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.

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Use with Opioids: Increase the risk of respiratory depression (7.1)

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Use with Other CNS Depressants: Produces additive CNS depressant effects (7.1)

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Use with CYP 3A4 Inhibitors: Increased risk of adverse reactions (4, 5.8, 7.1)

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