HALCION®, CIV (triazolam) 8 USE IN SPECIFIC POPULATIONS

(triazolam)

Prescribing Information

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including Halcion, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/

Risk Summary

Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see Warnings and Precautions (5.10) and Clinical Considerations]. Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Data).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation in neonates. Monitor neonates exposed to Halcion during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems. Monitor neonates exposed to HALCION during pregnancy for signs of withdrawal. Manage these neonates accordingly [see Warnings and Precautions (5.10)].

Data

Human Data

Published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects. Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. In addition, the majority of more recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco and other medications, have not confirmed these findings.

Animal Data

Oral administration of triazolam to pregnant rats and rabbits during the period of organogenesis caused skeletal developmental changes (variations and malformations) at maternally toxic doses in rats and at doses in rats and rabbits which are approximately equal to or greater than 200 times the maximum recommended human dose (MRHD) of 0.5 mg/day based on mg/m2 body surface area. Oral administration of triazolam to male and female rats before mating, and continuing during gestation and lactation did not result in embryotoxicity at doses up to approximately 100 times the MRHD based on mg/m2 body surface area, but did cause an increase in the number of stillbirths and postnatal pup mortalities at doses greater than or equal to approximately 40 times the MRHD based mg/m2 body surface area. 14C-triazolam was administered orally to pregnant mice. Drug-related material appeared uniformly distributed in the fetus with 14C concentrations approximately the same as in the brain of the mother.

8.2 Lactation

Risk Summary

There are reports of sedation, poor feeding and poor weight gain in infants exposed to benzodiazepines through breast milk. There are no data on the presence of triazolam in human milk or the effects on milk production. Triazolam and its metabolites are present in the milk of lactating rats (see Data). When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for HALCION and any potential adverse effects on the breastfed infant from HALCION or from the underlying maternal condition.

Clinical Considerations

Infants exposed to HALCION through breast milk should be monitored for sedation, poor feeding and poor weight gain. A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 28 hours (approximately 5 elimination half-lives) after HALCION administration in order to minimize drug exposure to a breast fed infant.

Data

Both triazolam and triazolam metabolites were detected in milk of rats. Lactating rats were orally administered 0.3 mg/kg 14C-triazolam; drug and metabolite levels were determined in milk collected at 6 and 24 hours after administration.

8.4 Pediatric Use

Safety and effectiveness of Halcion have not been established in pediatric patients.

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)].

Medication Guide

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 7/2024
What is the most important information I should know about HALCION? • HALCION is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Get emergency help right away if any of the following happens: o shallow or slowed breathing o breathing stops (which may lead to the heart stopping) o excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking HALCION with opioids affects you. • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including HALCION which can lead to overdose and serious side effects including coma and death. o Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including HALCION. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. o You can develop an addiction even if you take HALCION as prescribed by your healthcare provider. o Take HALCION exactly as your healthcare provider prescribed. o Do not share your HALCION with other people. o Keep HALCION in a safe place and away from children. • Physical dependence and withdrawal reactions. HALCION can cause physical dependence and withdrawal reactions. o Do not suddenly stop taking HALCION. Stopping HALCION suddenly can cause serious and life-threatening side effects, including unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms. o Some people who suddenly stop benzodiazepines, have symptoms that can last for several weeks to more than 12 months, including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears. o 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. o Do not take more HALCION than prescribed or take HALCION for longer than prescribed. • 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:
	o driving a car ("sleep-driving") o making and eating food o talking on the phone	o having sex o sleep-walking
	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. • HALCION is a federal controlled substance (CIV) because it contains triazolam that 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. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs. • 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. o Taking HALCION late in pregnancy may cause your baby to have symptoms of sedation (breathing problems, sluggishness, low muscle tone), and/or withdrawal symptoms (jitteriness, irritability, restlessness, shaking, excessive crying, feeding problems). o Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with HALCION. o There is a pregnancy registry for women who take HALCION during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. If you become pregnant during treatment with HALCION, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychiatric Medications. You can register by calling 1-866-961-2388 or visiting https://womensmentalhealth.org/pregnancyregistry/ • are breastfeeding or plan to breastfeed. It is not known if HALCION can pass through your breast milk. o Breastfeeding during treatment with HALCION may cause your baby to have sleepiness, feeding problems, and decreased weight gain. o 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 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 • HALCION can make you sleepy or dizzy and can slow your thinking and motor skills. o Do not drive, operate heavy machinery, or do other dangerous activities until you know how HALCION affects you. o Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking HALCION without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, HALCION may make your sleepiness or dizziness much worse. • Worsening depression. Call your healthcare provider right away if you have any thoughts of suicide or dying or worsening depression.
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. If you would like more information, call 1-800-438-1985 or visit www.pfizer.com. LAB-0259-19.0

Additional Resources

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine or vaccine.

Speak with a Pfizer Medical Information Professional regarding your Pfizer medicine or vaccine inquiry.

Available 9AM-5PM ET Monday to Friday; excluding holidays.

Submit a medical question for a Pfizer medicine or a vaccine.

The submission will be reviewed during our standard business hours.

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, click the link below to submit your information:
Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.