Halcion

• •
  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

  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 patients and caregivers about the risks of respiratory depression and sedation when Halcion is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined

  [see Drug Interactions (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 GABAAsites 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 Halcion 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 Halcion during concomitant use with CNS depressants.
  Strong Inhibitors of CYP 3A
  Clinical implication	Concomitant use of Halcion with strong CYP3A inhibitors has a profound effect on the clearance of Halcion, resulting in increased concentrations of triazolam and increased risk of adverse reactions [see Clinical Pharmacology (12.3)].
  Prevention or management	Do not administer Halcion 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 Halcion with moderate or weak inhibitors of CYP3A inhibitors may increase the concentrations of Halcion, resulting in increased risk of adverse reactions [see Clinical Pharmacology (12.3)].
  Prevention or management	Use with caution and consider appropriate dose reduction of HALCION 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 Halcion 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 Halcion with any of these drugs. [see Warnings and Precautions (5.8)].

  ]

  .
• •
  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

  5.2 Abuse, Misuse, and Addiction

  The use of benzodiazepines, including Halcion, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death

  [see Drug Abuse and Dependence (9.2)]

  .

  Before prescribing Halcion and throughout treatment, assess each patient's risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). Use of Halcion, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of Halcion along with monitoring for signs and symptoms of abuse, misuse, and addiction. Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate.

  ]

  .
• •
  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

  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)].

  ,

  5.3 Dependence and Withdrawal Reactions

  To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Halcion or reduce the dosage (a patient-specific plan should be used to taper the dose)

  [see Dosage and Administration (2.3)]

  .

  Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use.

  Acute Withdrawal Reactions

  The continued use of benzodiazepines, including Halcion, may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of Halcion after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures)

  [see Drug Abuse and Dependence (9.3)]

  .

  Protracted Withdrawal Syndrome

  In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months

  [see Drug Abuse and Dependence (9.3)]

  .

  ]

  .

Halcion is 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 (
  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.
  )
• •
  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 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)]

  .
  ,
  8.5 Geriatric Use

  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)]

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

Halcion is available as 0.25 mg tablets. The tablets are powder blue, elliptical, scored, and imprinted with HALCION 0.25.