Halcion
TRIAZOLAM
Indications and usage 1 INDICATIONS AND USAGE Halcion is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults.
Halcion is a benzodiazepine indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION • Adults : Recommended dosage is 0.25 mg once daily before bedtime.
Structured Monograph
Clinical summary
Indications and usage 1 INDICATIONS AND USAGE Halcion is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. Halcion is a benzodiazepine indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. ( 1 ) Dosage and administration 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 ) • Halcion 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. Use the lowest effective dose for the patient as there are significant dose related adverse reactions. Use of Halcion for more than 3 weeks requires evaluation of the patient for a primary psychiatric or medical condition [see Warnings and Precautions (5.4 , 5.6) ] . Prescriptions for Halcion should be written for short-term use (7 to 10 days) and it should not be prescribed in quantities exceeding a 1-month supply. 2.2 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. Elderly patients have an increased risk of dose related adverse reactions [see Use in Specific Populations (8.5) ] . 2.3 Discontinuation or Dosage Reduction of Halcion To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Halcion or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly [see Warnings and Precautions (5.3) , Drug Abuse and Dependence (9.3) ]. Warnings and cautions 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. ( 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 ) 5.1 Risks From Concomitant Use With Opioids Concomitant use of benzodiazepines, including Halcion, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe Halcion concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of Halcion than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking Halcion, prescribe a lower initial dose of the opioid and titrate based upon clinical response. Advise both pati
Boxed Warning
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. Follow patients for signs and symptoms of respiratory depression and sedation [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ] . • The use of benzodiazepines, including Halcion, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing Halcion and throughout treatment, assess each patient's risk for abuse, misuse, and addiction [see Warnings and Precautions (5.2) ] . • The continued use of benzodiazepines, including Halcion, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. 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 [see Dosage and Administration (2.3) , Warnings and Precautions (5.3) ] . 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 ).
Monitoring
- • 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.
Interaction Notes
- • 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 Halcion Table 2 includes clinically significant drug interactions with Halcion [see Clinical Pharmacology (12.3) ] .
- • Table 2: Clinically Important Drug Interactions with Halcion 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.