HALCION®, CIV (triazolam) 6 ADVERSE REACTIONS

(triazolam)

Prescribing Information

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections:

•: Risks from Concomitant Use with Opioids [see Warnings and Precautions (5.1)]
•: Abuse, Misuse, and Addiction [see Warnings and Precautions (5.2)]
•: Dependence and Withdrawal Reactions [see Warnings and Precautions (5.3)]
•: Persistent or Worsening Insomnia [see Warnings and Precautions (5.4)]
•: "Sleep-driving" and Other Complex Behaviors [see Warnings and Precautions (5.5)]
•: Central Nervous System Manifestations [see Warnings and Precautions (5.6)]
•: Effects on Driving and Operating Heavy Machinery [see Warnings and Precautions (5.7)]
•: Patients with Depression [see Warnings and Precautions (5.9)]
•: Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions (5.10)]
•: Compromised Respiratory Function [see Warnings and Precautions (5.11)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The incidences cited below are estimates of clinical reactions among 1003 subjects who participated in the short term (duration of 1 to 42 days) placebo-controlled clinical trials of Halcion.

Adverse reactions leading to discontinuation in two multi-dose placebo controlled clinical trials include coordination disorders, drowsiness, grogginess, somnolence, depression, restlessness, dizziness, lightheadedness, headache, nausea, visual disturbance, nervousness, abdominal distress, bladder trouble, aching limbs, backache, and blepharitis.

Table 1: Common Adverse Drug Reactions in 1% or More of Halcion-Treated Subjects (and Greater than Placebo) Reported in Placebo-Controlled Clinical Trials
Event	Halcion (N=1003) % Patients Reporting	Placebo (N=997) % Patients Reporting
Central Nervous System
Drowsiness	14.0	6.4
Headache	9.7	8.4
Dizziness	7.8	3.1
Nervousness	5.2	4.5
Light-headedness	4.9	0.9
Coordination disorders/ataxia	4.6	0.8
Gastrointestinal
Nausea/vomiting	4.6	3.7

In addition to the common reactions enumerated above in Table1, the following adverse reactions have been reported at an incidence of 0.9% to 0.5%: euphoria, tachycardia, tiredness, confusional states/memory impairment, cramps/pain, depression, and visual disturbances.

Adverse reactions reported at an incidence less than 0.5% include: constipation, taste alterations, diarrhea, dry mouth, dermatitis/allergy, dreaming/nightmares, insomnia, paresthesia, tinnitus, dysesthesia, weakness, congestion, and death from hepatic failure in a patient also receiving diuretic drugs.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Halcion. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General disorders and administration site conditions: Paradoxical drug reaction, chest pain and fatigue
Gastrointestinal disorders: Tongue discomfort, glossitis, stomatitis
Hepatobiliary disorders: Jaundice
Injury, poisoning and procedural complications: Fall
Metabolism and nutrition disorders: Anorexia
Nervous system disorders: Anterograde amnesia, altered state of consciousness, dystonia, sedation, syncope, dysarthria and muscle spasticity
Psychiatric disorders: Confusional state (disorientation, derealisation, depersonalization), mania, agitation, restlessness, irritability, sleep disorder and libido disorder, hallucination, delusion, aggression, somnambulism, and abnormal behavior
Renal and urinary disorders: Urinary retention and urinary incontinence
Reproductive system and breast disorders: Menstruation irregular
Skin and subcutaneous tissue disorders: Pruritis

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

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