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HALCION®, CIV (triazolam) Medication Guide

MEDICATION GUIDE
HALCION (HAL-cee-on)
(triazolam)
tablets, CIV
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised 10/2019  
What is the most important information I should know about HALCION?
  • HALCION is a benzodiazepine medicine. Benzodiazepines can cause severe drowsiness, breathing problems (respiratory depression), coma and death when taken with opioid medicines. After taking HALCION, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with HALCION. Reported activities include:
  • driving a car ("sleep-driving")
  • making and eating food
  • talking on the phone
  • having sex
  • sleep-walking
Call your healthcare provider right away if you find out that you have done any of the above activities after taking HALCION.
  • Do not take more HALCION than prescribed or take HALCION for longer than prescribed.
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.
  • HALCION is a federal controlled substance (CIV) because it can be abused or lead to dependence. Keep HALCION in a safe place to prevent misuse and abuse. Selling or giving away HALCION may harm others and is against the law.
  • It is not known if HALCION is safe and effective in children.
  • It is not known if HALCION is safe and effective for use longer than 2 to 3 weeks.
Do not take HALCION if you:
  • are allergic to triazolam, other benzodiazepines, or any of the ingredients in HALCION. Severe allergic reactions including swelling of the tongue or throat, trouble breathing and throat closing have happened and may lead to death. Get medical help right away if you have an allergic reaction to HALCION. See the end of this Medication Guide for a complete list of ingredients in HALCION.
  • take antifungal medicines including ketoconazole and itraconazole
  • take a medicine to treat depression called nefazodone
  • take medicines to treat human immunodeficiency virus (HIV)-1 infection called protease inhibitors.
Before you take HALCION, tell your healthcare provider about all of your medical conditions, including if you:
  • have a history of depression, mood problems, mental illness, suicidal thoughts or behavior
  • have a history of drug or alcohol abuse or addiction
  • have lung problems, breathing problems, or sleep apnea
  • are pregnant or plan to become pregnant.
    • If you become pregnant while taking HALCION, talk to your healthcare provider about registering with the National Pregnancy Registry for psychiatric medicines during pregnancy. You can register by calling 1-866-961-2388 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.
    • Babies born to mothers who take benzodiazepine medicines, including HALCION, late in pregnancy may have symptoms of sedation, such as breathing problems, sluggishness, and low muscle tone (floppy baby syndrome), feeding problems and withdrawal symptoms.
  • are breastfeeding or plan to breastfeed. It is not known if HALCION can pass through your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take HALCION.
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?
  • Take HALCION exactly as your healthcare provider tells you to take it.
  • Take HALCION right before you get into bed.
  • Do not eat grapefruit or drink grapefruit juice during treatment with HALCION.
  • Call your healthcare provider if your insomnia worsens or is not better within 7 to 10 days of treatment with HALCION. This may mean that there is another condition causing your sleep problem.
  • If you take too much HALCION, call your healthcare provider or have somebody drive you to the nearest hospital emergency room right away.
What should I avoid while taking HALCION?
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how HALCION affects you.
  • Do not drink alcohol or take other medicines that may make you sleepy or dizzy during treatment with HALCION. When taken with alcohol or medicines that cause sleepiness or dizziness, HALCION may make your sleepiness or dizziness much worse.
What are the possible side effects of HALCION?
HALCION may cause serious side effects, including:
  • See "What is the most important information I should know about HALCION?"
  • Increased daytime anxiety.
  • Abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.
  • Memory loss
  • Worsening depression. Call your healthcare provider right away if you have any thoughts of suicide or dying or worsening depression.
  • Withdrawal symptoms. You can have withdrawal symptoms after you stop taking HALCION even if you have taken it for only a week or two. The withdrawal symptoms may be more common and severe after continuous use. Withdrawal symptoms include trouble sleeping, increased symptoms of daytime anxiety or nervousness, stomach and muscle cramps, vomiting, sweating, shakiness, and seizures. You may also have a symptom called "rebound insomnia" after you stop taking HALCION. Rebound insomnia can happen on the first few nights after HALCION is stopped and your sleep problems may be worse than before taking HALCION. Talk to your healthcare provider about slowly stopping HALCION.
  • Abuse and dependence. Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
The most common side effects of HALCION include:
  • drowsiness
  • dizziness
  • light-headedness
  • difficulty with coordination
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?
  • Store HALCION at room temperature between 68°F to 77° F (20°C to 25°C).
  • Keep HALCION and all medicines out of the reach of children
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.

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