|This Medication Guide has been approved by the U.S. Food and Drug Administration.||Revised 2/2021|
|What is the most important information I should know about HALCION?|
|Call your healthcare provider right away if you find out that you have done any of the above activities after taking HALCION.|
|What is HALCION?|
|HALCION is a prescription medicine used in adults for the short-term treatment of a sleep problem called insomnia. HALCION is usually taken for 7 to 10 days.|
|Do not take HALCION if you:|
|Before you take HALCION, tell your healthcare provider about all of your medical conditions, including if you:|
|Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.|
|Taking HALCION with certain other medicines can cause side effects or affect how well HALCION or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.|
|How should I take HALCION?|
|What are the possible side effects of HALCION?|
|HALCION may cause serious side effects, including:|
|The most common side effects of HALCION include:|
|Elderly people have an increased risk of dose related side effects during treatment with HALCION.|
|These are not all the possible side effects of HALCION.|
|Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.|
|How should I store HALCION?|
|General information about the safe and effective use of HALCION.|
|Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use HALCION for a condition for which it was not prescribed. Do not give HALCION to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about HALCION that is written for healthcare professionals.|
|What are the ingredients in HALCION?|
|Active ingredient: triazolam|
|Inactive ingredients: cellulose, corn starch, docusate sodium, FD&C Blue No. 2, lactose, magnesium stearate, silicon dioxide, sodium benzoate.|
|If you would like more information, call 1-800-438-1985 or visit www.pfizer.com.|
17 PATIENT COUNSELING INFORMATION
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 Halcion 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 (5.1), Drug Interactions (7.1)].
Abuse, Misuse, and Addiction
Inform patients that the use of Halcion, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug [see Warnings and Precautions (5.2), Drug Abuse and Dependence (9.2)].
Inform patients that the continued use of Halcion may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of Halcion may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months. Instruct patients that discontinuation or dosage reduction of Halcion may require a slow taper [see Warnings and Precautions (5.3), Drug Abuse and Dependence (9.3)].
"Sleep-driving" and Other Complex Behaviors
There have been reports of people getting out of bed after taking a sedative-hypnotic and driving their cars while not fully awake, often with no memory of the event. Advise patients to report similar experiences to their healthcare provider immediately, since "sleep-driving" can be dangerous. This behavior is more likely to occur when sedative-hypnotics are taken with alcohol or other CNS depressants [see Warnings and Precautions (5.5)]. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative hypnotic. As with sleep-driving, patients usually do not remember these events.
Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients.
Effects on Driving and Operating Heavy Machinery
Caution patients against driving a motor vehicle or operating heavy machinery until the effects of taking Halcion are determined due to its CNS depressant effects. Also advise patients to avoid the use of alcohol or other CNS depressants while taking Halcion [see Warnings and Precautions (5.7)].
Patients with Depression
Advise patients, their families and caregivers to look out for any signs of suicidality or worsening depression, and to inform the patient's prescriber or healthcare provider immediately [see Warnings and Precautions (5.9)].
Advise patients to inform their healthcare provider of all medicines they take, including prescription and nonprescription medicines, vitamins and herbal supplements [see Drug Interactions (7.1)].
Advise patients to avoid eating grapefruit or drinking grapefruit juice while taking Halcion [see Drug Interactions (7.1)].
Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates. Advise mothers using Halcion to monitor neonates for signs of sedation, respiratory depression, withdrawal, and feeding problems [see Warnings and Precautions (5.10), Use in Specific Populations (8.1)].
Advise mothers using benzodiazepines to monitor neonates for signs of sedation, respiratory depression, withdrawal symptoms, and feeding problems. A lactating woman may consider pumping and discarding breastmilk during treatment and for 28 hours after Halcion administration to minimize drug exposure to a breastfed infant [see Use in Specific Populations (8.2)].