MEDICATION GUIDE Triazolam tablets, CIV
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised 6/2023
What is the most important information I should know about triazolam? • Triazolam 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 triazolam with opioids affects you. • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including triazolam 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 triazolam. 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 triazolam as prescribed by your healthcare provider. o Take triazolam exactly as your healthcare provider prescribed. o Do not share your triazolam with other people. o Keep triazolam in a safe place and away from children. • Physical dependence and withdrawal reactions. Triazolam can cause physical dependence and withdrawal reactions. o Do not suddenly stop taking triazolam. Stopping triazolam 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 triazolam than prescribed or take triazolam for longer than prescribed. • After taking triazolam, 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 triazolam. 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 triazolam.
What is triazolam? Triazolam is a prescription medicine used in adults for the short-term treatment of a sleep problem called insomnia. Triazolam is usually taken for 7 to 10 days. • Triazolam is a federal controlled substance (CIV) because it contains triazolam that can be abused or lead to dependence. Keep triazolam in a safe place to prevent misuse and abuse. Selling or giving away triazolam 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 triazolam is safe and effective in children. • It is not known if triazolam is safe and effective for use longer than 2 to 3 weeks.
Do not take triazolam if you: • are allergic to triazolam, other benzodiazepines, or any of the ingredients in triazolam. 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 triazolam. See the end of this Medication Guide for a complete list of ingredients in triazolam. • 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 triazolam, 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 triazolam 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 triazolam. o There is a pregnancy registry for women who take triazolam 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 triazolam, 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 triazolam can pass through your breast milk. o Breastfeeding during treatment with triazolam 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 triazolam. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking triazolam with certain other medicines can cause side effects or affect how well triazolam or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
How should I take triazolam? • Take triazolam exactly as your healthcare provider tells you to take it. • Take triazolam right before you get into bed. • Do not eat grapefruit or drink grapefruit juice during treatment with triazolam. • Call your healthcare provider if your insomnia worsens or is not better within 7 to 10 days of treatment with triazolam. This may mean that there is another condition causing your sleep problem. • If you take too much triazolam, call your healthcare provider or have somebody drive you to the nearest hospital emergency room right away.
What are the possible side effects of triazolam? Triazolam may cause serious side effects, including: • See "What is the most important information I should know about triazolam?" • 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 • Triazolam 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 triazolam affects you. o Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking triazolam without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, triazolam 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 triazolam include:
	• drowsiness • dizziness	• light-headedness • difficulty with coordination
Elderly people have an increased risk of dose related side effects during treatment with triazolam. These are not all the possible side effects of triazolam. 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 triazolam? • Store triazolam at room temperature between 68°F to 77° F (20°C to 25°C). • Keep triazolam and all medicines out of the reach of children
General information about the safe and effective use of triazolam. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use triazolam for a condition for which it was not prescribed. Do not give triazolam 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 triazolam that is written for healthcare professionals.
What are the ingredients in triazolam? Active ingredient: triazolam Inactive ingredients: 0.125 mg tablet: cellulose, corn starch, docusate sodium, lactose, magnesium stearate, silicon dioxide, sodium benzoate. 0.25 mg tablet: 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. LAB-0260-14.0

triazolam

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