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Description

Generic Name

Alprazolam

Active Ingredient

Alprazolam

Chemical Name and Composition

Alprazolam is chemically described as 8-chloro-1-methyl-6-phenyl-4H-s-triazolo[4,3-a][1,4]benzodiazepine.

Alprazolam is a white to off-white crystalline powder. It is soluble in alcohol and practically insoluble in water. It has a molecular weight of about 308.76.

Medication Classification

Xanax is a benzodiazepine. It works by enhancing the activity of gamma-aminobutyric acid (GABA), a natural chemical in the brain that calms nerve activity. This calming effect helps reduce anxiety and panic symptoms.

Xanax is a Schedule IV (CIV) controlled substance under U.S. federal law.

Indications

Xanax is indicated for:

• The management of anxiety disorders, including generalized anxiety disorder, and the short-term relief of anxiety symptoms in adults
• The treatment of panic disorder, with or without agoraphobia, in adults

The extended-release form is generally used for panic disorder. Not every dosage form is approved for every use, so follow the specific indication set by your provider.

Dosage Forms and Available Strengths

• Dosage Forms:
• • Immediate-release oral tablets (Xanax)
  • Extended-release oral tablets (Xanax XR)
• Route of Administration: Oral
• Common Strengths:
• • Immediate-release tablets: 0.25 mg, 0.5 mg, 1 mg, and 2 mg
  • Extended-release tablets: 0.5 mg, 1 mg, 2 mg, and 3 mg

Formulations and strengths may vary by manufacturer. Confirm the exact strength on your product label.

Inactive Ingredients

Inactive ingredients vary by dosage form and manufacturer. Immediate-release tablets may contain cellulose, corn starch, docusate sodium, lactose, magnesium stearate, silicon dioxide, sodium benzoate, and colorants that differ by tablet strength. Extended-release tablets may contain lactose, hypromellose, magnesium stearate, and other release-controlling agents. Refer to the specific product packaging or your pharmacist for exact ingredient details, especially if you have allergies or intolerances.

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Dosage & Administration

Important: Take Xanax exactly as prescribed by your healthcare provider. Use the lowest effective dose for the shortest time needed. Your provider will set your dose based on your condition, your age, and your response, and will usually start low and adjust slowly. Do not change your dose or stop taking it without medical guidance.

How to Take Xanax

• Immediate-release tablets: Swallow with water. These are usually taken one to several times a day, depending on your condition and your provider's directions.
• Extended-release tablets (Xanax XR): Swallow the tablet whole. Do not chew, crush, or break it, as this can release too much medicine at once. These are usually taken once daily, often in the morning.
• Do not take more than prescribed, and do not take it more often than directed.

Food Considerations

Xanax may be taken with or without food. Avoid grapefruit and grapefruit juice, which may increase alprazolam levels in the body. Avoid alcohol entirely while taking Xanax, as the combination can cause dangerous drowsiness and slowed breathing.

Missed Dose Instructions

• If you miss a dose, take it as soon as you remember.
• If it is close to the time for your next dose, skip the missed dose and continue your regular schedule.
• Do not take two doses at once to make up for a missed dose.
• If you are unsure what to do, contact your healthcare provider or pharmacist.

Storage

• Store at 20° to 25°C (68° to 77°F), with brief excursions permitted between 15° to 30°C (59° to 86°F).
• Keep in a tightly closed container, away from moisture, heat, and light.
• Keep out of the reach of children.

Disposal

Because Xanax is a controlled substance, store and dispose of it carefully to prevent theft, misuse, or accidental exposure. Dispose of unused or expired medication through a drug take-back program when possible. If no take-back program is available, follow current FDA guidance for safe household disposal. Ask your pharmacist if you have questions about disposal.

Special Instructions

Children: The safety and effectiveness of Xanax have not been established in patients younger than 18 years of age. It is not recommended for use in this age group. Keep the medication out of the reach of children. If a child swallows this medication, seek emergency care immediately.

Elderly or Debilitated Patients: Older patients may be more sensitive to the effects of Xanax, including drowsiness, dizziness, confusion, and unsteadiness, which can raise the risk of falls. A provider may start at a lower dose and monitor closely. Take extra care when getting up or moving around.

Patients with Liver Problems: Use with caution. Alprazolam is broken down mainly by the liver, so impaired liver function can increase drug levels and prolong effects. A lower dose is often recommended for patients with advanced liver disease.

Patients with Kidney Problems: Use with caution. Reduced kidney function may affect how the body clears the medication. Your provider may adjust your dose and monitor you more closely.

Caregivers: Give the medication exactly as prescribed. Watch for excessive sleepiness, slowed or shallow breathing, confusion, trouble waking the patient, or unusual changes in mood or behavior, and seek care right away if these occur. Keep the medication secured and out of sight.

Tapering and Discontinuation

• Do not stop taking Xanax suddenly after regular or prolonged use. Abrupt discontinuation can cause withdrawal symptoms, some of which may be serious or life-threatening.
• If you and your provider decide to stop treatment, the dose should be reduced gradually using a plan set by your provider. Alprazolam may require an especially slow, careful taper.
• Withdrawal symptoms may include anxiety, trouble sleeping, irritability, sweating, tremor, muscle cramps, stomach upset, and, in severe cases, seizures.
• Some people may notice a return of anxiety or panic symptoms worse than before (rebound symptoms) after stopping. This usually improves over time.
• Tell your provider if withdrawal symptoms occur so your taper can be adjusted.

Overdose Warning

An overdose of Xanax can be serious and may be fatal, especially when combined with opioids, alcohol, or other central nervous system (CNS) depressants. Symptoms of overdose may include:

• Extreme drowsiness or difficulty staying awake
• Confusion
• Slurred speech
• Loss of coordination or unsteadiness
• Slowed or shallow breathing
• Weak or limp muscles
• Slow reflexes
• Loss of consciousness or coma

In case of a suspected overdose, call the Poison Control Center at 1-800-222-1222 or seek emergency medical care immediately. A medicine called flumazenil may be used in some cases to reverse the effects of benzodiazepines, but it must be used with caution because it can trigger seizures in people who are dependent on benzodiazepines.

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Side Effects

Serious Side Effects Requiring Immediate Medical Attention

Stop taking Xanax and seek emergency care or contact your healthcare provider right away if you experience any of the following:

• Respiratory depression: Slow, shallow, or difficult breathing, or extreme sleepiness, especially when combined with opioids or other CNS depressants.
• Severe allergic reactions, including angioedema: Swelling of the face, lips, tongue, or throat; trouble breathing or swallowing; hives; or a severe rash. These can be life-threatening and may occur after the first dose or later.
• Complex sleep behaviors: Doing activities while not fully awake, such as sleep-walking, sleep-driving, or preparing food, with no memory of the event. These behaviors can cause serious injury or death.
• Suicidal thoughts or worsening depression: New or worsening depression, or thoughts of harming yourself.
• Paradoxical reactions: Unexpected effects such as increased anxiety, agitation, restlessness, aggression, irritability, rage, hallucinations, or unusual changes in behavior.
• Severe withdrawal reactions: Serious symptoms, including seizures, that can occur if the medication is stopped suddenly or the dose is reduced too quickly.

Common Side Effects

The following side effects may occur and are not always cause for urgent concern. Talk to your healthcare provider if they persist or become bothersome:

• Drowsiness or sleepiness
• Dizziness or lightheadedness
• Memory problems (impaired memory)
• Dry mouth
• Fatigue or tiredness
• Loss of coordination or unsteadiness
• Slurred speech
• Changes in appetite or weight

This is not a complete list of possible side effects. Contact your healthcare provider for guidance about any symptoms that concern you.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088

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Warnings & Precautions

FDA Boxed Warning: Risks from Concomitant Use with Opioids; Abuse, Misuse, and Addiction; and Dependence and Withdrawal Reactions

• Risks from concomitant use with opioids: Combining benzodiazepines such as Xanax with opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with no alternative treatment options, and limit the dose and duration to the minimum required.
• Abuse, misuse, and addiction: The use of benzodiazepines, including Xanax, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Assess each patient's risk before prescribing and monitor throughout treatment.
• Dependence and withdrawal reactions: Continued use may lead to physical dependence, even at recommended doses. Stopping the medication suddenly or reducing the dose too quickly can cause serious, sometimes life-threatening, withdrawal reactions. To reduce this risk, the dose should be lowered gradually.

Conditions to Disclose to Your Healthcare Provider

Before taking Xanax, tell your healthcare provider if you have or have had any of the following:

• Breathing problems, such as chronic obstructive pulmonary disease (COPD), asthma, or sleep apnea
• Liver or kidney problems
• Depression, mood problems, or thoughts of suicide
• A history of unusual behavior or complex sleep behaviors while taking a sedative medicine
• Seizures or a seizure disorder
• Glaucoma, especially narrow-angle glaucoma
• A history of alcohol, prescription medicine, or street drug abuse or dependence
• Pregnancy or plans to become pregnant
• Breastfeeding or plans to breastfeed

Contraindications

Do not take Xanax if you:

• Have a known hypersensitivity to alprazolam, other benzodiazepines, or any component of the formulation
• Have acute narrow-angle glaucoma
• Are taking strong CYP3A4 inhibitors, such as certain antifungals including ketoconazole or itraconazole, because these can dangerously increase alprazolam levels in the body

Drug Interactions

Tell your healthcare provider and pharmacist about all medications, supplements, and herbal products you take. Because alprazolam is processed mainly by the CYP3A4 liver enzyme, many drugs can affect its levels. Key interactions include:

• Opioids: Combining Xanax with opioids increases the risk of severe drowsiness, respiratory depression, coma, and death.
• Other CNS depressants: Sedatives, tranquilizers, other sleep medicines, muscle relaxants, certain antidepressants, antihistamines, and antipsychotics can add to drowsiness and breathing problems.
• Alcohol: Drinking alcohol while taking Xanax can dangerously increase sedation and the risk of slowed breathing. Avoid alcohol entirely.
• Strong CYP3A4 inhibitors: Drugs such as ketoconazole and itraconazole are contraindicated with Xanax. Other inhibitors, such as certain macrolide antibiotics, some HIV medications, nefazodone, and fluvoxamine, may increase alprazolam levels and the risk of side effects.
• CYP3A4 inducers: Drugs such as rifampin, carbamazepine, and phenytoin may reduce alprazolam's effectiveness.
• Grapefruit and grapefruit juice: May increase alprazolam levels in the body.
• Other sedating medicines: Any medicine that causes drowsiness may increase the sedative effects of Xanax.

Monitoring Requirements

Your healthcare provider may monitor:

• Your response to treatment and whether your symptoms improve
• Signs of excessive sedation or respiratory depression, especially with other CNS depressants
• New or worsening mood, behavior, or mental health changes, including thoughts of self-harm
• Reports of complex sleep behaviors or paradoxical reactions
• Signs of tolerance, dependence, or misuse
• Signs of withdrawal if the dose is reduced or the medication is stopped

Abuse, Dependence, and Misuse Warnings

Xanax is a Schedule IV controlled substance.

• Benzodiazepines such as Xanax can be misused and may be a target for people who abuse prescription medicines. The risk may be higher in people with a history of substance abuse.
• Physical dependence and tolerance can develop with continued use, even at prescribed doses. Physical dependence means you should not stop suddenly.
• Tolerance may develop, meaning the medication may become less effective over time. Do not increase your dose on your own.
• Do not sell or give away Xanax. Doing so may harm others and is against the law.
• Misusing this medication can cause overdose and death, especially when combined with other substances.

Long-Term Use Considerations

• The safety and effectiveness of long-term use have not been fully established. Your provider should regularly reassess whether continued treatment is appropriate.
• Physical dependence and tolerance may develop with continued use. Any decision to stop treatment should involve a gradual, supervised taper.
• Long-term use may increase the risk of memory problems and cognitive effects, particularly in older adults.
• Do not take Xanax for longer than prescribed without discussing it with your provider.

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Patient Counseling Information

Safe Medication Use

• Take Xanax exactly as prescribed. Do not take more than directed or use it more often than prescribed.
• Swallow extended-release tablets whole. Do not chew, crush, or break them.
• Do not stop taking Xanax suddenly after regular use. Talk to your healthcare provider about a safe tapering plan.
• Do not share Xanax with anyone else. Sharing is dangerous and against the law.
• Keep Xanax in a safe, secure place, away from children and others, to prevent accidental exposure, misuse, or theft.
• Read the FDA-approved Medication Guide provided with your prescription.

Risk Prevention

• Opioids and CNS depressants: Do not use these with Xanax unless directed by your provider. The combination can cause severe drowsiness, breathing problems, coma, and death.
• Alcohol: Do not drink alcohol while taking Xanax. Alcohol adds to the sedative effect and can be dangerous.
• Complex sleep behaviors: Stop taking Xanax and tell your provider right away if you learn you have done activities such as driving, eating, or walking while not fully awake, with no memory of it.
• Driving and machinery: Xanax can cause drowsiness, dizziness, and slowed thinking. Do not drive or operate heavy machinery until you know how it affects you.
• Grapefruit: Avoid grapefruit and grapefruit juice, which can increase alprazolam levels in your body.
• Mental health: Tell your provider about any new or worsening depression, unusual behavior, or thoughts of self-harm.
• Pregnancy: Tell your provider right away if you are pregnant or plan to become pregnant. Using Xanax during pregnancy, especially later in pregnancy, may cause harm to the baby, including sedation and withdrawal symptoms after birth.
• Breastfeeding: Alprazolam can pass into breast milk and may affect a nursing baby. Talk to your provider before breastfeeding while taking Xanax.
• All medicines: Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Do not start or stop other medicines without talking to your provider first.

When to Contact a Healthcare Provider

Contact your healthcare provider or seek emergency care right away if you:

• Have slow, shallow, or difficult breathing, or extreme sleepiness you cannot fight off
• Cannot be easily woken up
• Have a severe allergic reaction, such as swelling of the face, lips, tongue, or throat, hives, or trouble breathing
• Learn you have done activities while asleep or not fully awake, such as sleep-driving or sleep-walking
• Develop new or worsening depression, unusual behavior, or thoughts of harming yourself
• Experience a paradoxical reaction, such as increased anxiety, agitation, aggression, or hallucinations
• Have a seizure or other withdrawal symptoms after reducing or stopping the medication
• Notice memory problems, confusion, or feeling detached from reality
• Have any symptom that concerns you or does not go away

For a suspected overdose, call the Poison Control Center at 1-800-222-1222 or seek emergency medical care immediately. To report suspected side effects, contact the FDA at 1-800-FDA-1088