Alprazolam 0.25mg ODT Tablets
WARNING: This drug is a benzodiazepine. The use of a benzodiazepine drug along with opioid drugs has led to very bad side effects. Side effects that have happened include slowed or trouble breathing and death. Opioid drugs include drugs like codeine, oxycodone, and morphine. Opioid drugs are used to treat pain and some are used to treat cough. Talk with the doctor.If you are taking this drug with an opioid drug, get medical help right away if you feel very sleepy or dizzy; if you have slow, shallow, or trouble breathing; or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up. Benzodiazepines can put you at risk for drug use disorder. Misuse or abuse of this drug can lead to overdose or death, especially when used along with certain other drugs, alcohol, or street drugs. Drug use disorder can happen even if you take this drug as your doctor has told you. Get medical help right away if you have changes in mood or behavior, suicidal thoughts or actions, seizures, or trouble breathing.You will be watched closely to make sure you do not misuse this drug or develop drug use disorder.Benzodiazepines may cause dependence. Lowering the dose or stopping this drug all of a sudden may cause withdrawal. This can be life- threatening. The risk of dependence and withdrawal are raised the longer you take this drug and the higher the dose. Talk to your doctor before you lower the dose or stop this drug. You will need to follow your doctor's instructions. Get medical help right away if you have trouble controlling body movements, seizures, new or worse behavior or mood changes like depression or thoughts of suicide, thoughts of harming someone, hallucinations (seeing or hearing things that are not there), losing contact with reality, moving around or talking a lot, or any other bad effects.Sometimes, withdrawal signs can last for several weeks to more than 12 months. Tell your doctor if you have anxiety; trouble with memory, learning, or focusing; trouble sleeping; burning, numbness, or tingling; weakness; shaking; muscle twitching; ringing in the ears; or any other bad effects. @ COMMON USES: It is used to treat anxiety.It is used to treat panic attacks.
Drug Class
Anxiolytic; Sedative-Hypnotic
Pharmacologic Class
Benzodiazepine
Pregnancy Category
Category D
FDA Approved
Aug 2005
DEA Schedule
Schedule IV
Overview
What is this medicine?
Alprazolam is a medication in the benzodiazepine class. It works by calming the brain and nerves, helping to reduce anxiety and panic attacks. The ODT (Orally Disintegrating Tablet) form dissolves quickly in your mouth without water.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect.
When taking the medication, make sure to handle the tablets carefully. If they come in a foil blister pack, do not push the tablet out of the foil. Instead, use dry hands to remove it from the packaging. Place the tablet on your tongue and let it dissolve completely. You do not need to drink water with it. It's essential to let the tablet dissolve and not swallow it whole, chew, break, or crush it.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep it in a safe location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or secure area to store your medication. Keep all medications out of reach of pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore local drug take-back programs in your area.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect.
When taking the medication, make sure to handle the tablets carefully. If they come in a foil blister pack, do not push the tablet out of the foil. Instead, use dry hands to remove it from the packaging. Place the tablet on your tongue and let it dissolve completely. You do not need to drink water with it. It's essential to let the tablet dissolve and not swallow it whole, chew, break, or crush it.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep it in a safe location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or secure area to store your medication. Keep all medications out of reach of pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore local drug take-back programs in your area.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
Lifestyle & Tips
- Avoid alcohol and other CNS depressants while taking this medication.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
- Do not stop taking this medication suddenly, especially if you have been taking it regularly, as this can lead to withdrawal symptoms. Your doctor will guide you on how to slowly reduce the dose.
- Store at room temperature away from moisture and heat.
- Keep out of reach of children and pets.
Available Forms & Alternatives
Available Strengths:
- Alprazolam 0.25mg Tablets
- Alprazolam 0.5mg Tablets
- Alprazolam 1mg Tablets
- Alprazolam 2mg Tablets
- Alprazolam Con 1mg/ml Solution
- Alprazolam 2mg ODT Tablets
- Alprazolam 1mg ODT Tablets
- Alprazolam 0.5mg ODT Tablets
- Alprazolam 0.25mg ODT Tablets
- Alprazolam ER 1mg Tablets
- Alprazolam ER 2mg Tablets
- Alprazolam XR 3mg Tablets
- Alprazolam ER 0.5mg Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
Anxiety: 0.25-0.5 mg orally 3 times daily. Panic Disorder: 0.5 mg orally 3 times daily.
Dose Range:
0.25 - 4 mg
Condition-Specific Dosing:
anxiety_disorder:
Initial: 0.25-0.5 mg orally 3 times daily. Max: 4 mg/day in divided doses.
panic_disorder:
Initial: 0.5 mg orally 3 times daily. May increase by no more than 1 mg/day every 3-4 days. Max: 10 mg/day in divided doses.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (safety and efficacy not established)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
Use with caution, consider lower doses.
Dialysis:
Not significantly dialyzable; use with caution, consider lower doses.
Hepatic Impairment:
Mild:
Consider lower initial doses (e.g., 0.25 mg 2-3 times daily).
Moderate:
Consider lower initial doses (e.g., 0.25 mg 2-3 times daily).
Severe:
Contraindicated or use with extreme caution; significant dose reduction required (e.g., 0.25 mg once daily or every other day).
Pharmacology
Mechanism of Action
Alprazolam, a benzodiazepine, binds to stereospecific benzodiazepine receptors on the postsynaptic GABA-A neuron at various sites within the central nervous system, including the limbic system, reticular formation, and cerebral cortex. This binding enhances the inhibitory effects of gamma-aminobutyric acid (GABA), leading to increased chloride ion influx, hyperpolarization of the neuronal membrane, and stabilization of the neuron, resulting in anxiolytic, sedative, hypnotic, muscle relaxant, and anticonvulsant effects.
Pharmacokinetics
Absorption:
Bioavailability:
80-90%
Tmax:
1-2 hours (for ODT formulation, may be slightly faster than IR)
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
0.9-1.2 L/kg
ProteinBinding:
80%
CnssPenetration:
Yes
Elimination:
HalfLife:
11.2 hours (range: 6.3-26.9 hours)
Clearance:
Not available
ExcretionRoute:
Renal (urine)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Within 30 minutes
PeakEffect:
1-2 hours
DurationOfAction:
4-6 hours
Safety & Warnings
BLACK BOX WARNING
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. The risks of abuse, misuse, and addiction, even at recommended doses, and physical dependence and withdrawal reactions, even with gradual discontinuation, are serious. Assess each patient's risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of depression, suicidal thoughts, or mood changes, including:
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Sudden change in balance
Shortness of breath
Severe dizziness or fainting
Confusion
Memory problems or loss
Difficulty speaking
Trouble urinating
Loss of control over body movements
Muscle twitching
Rapid heartbeat
Blurred vision
Changes in menstrual period (in women)
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness, drowsiness, fatigue, or weakness
Dry mouth
Changes in appetite
Constipation, diarrhea, vomiting, or stomach upset
Changes in sex drive
Sexual problems
Weight gain or loss
Sleep disturbances
Headache
Excessive sweating
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of depression, suicidal thoughts, or mood changes, including:
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Sudden change in balance
Shortness of breath
Severe dizziness or fainting
Confusion
Memory problems or loss
Difficulty speaking
Trouble urinating
Loss of control over body movements
Muscle twitching
Rapid heartbeat
Blurred vision
Changes in menstrual period (in women)
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness, drowsiness, fatigue, or weakness
Dry mouth
Changes in appetite
Constipation, diarrhea, vomiting, or stomach upset
Changes in sex drive
Sexual problems
Weight gain or loss
Sleep disturbances
Headache
Excessive sweating
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Extreme drowsiness or sedation
- Difficulty breathing or shallow breathing
- Unusual confusion or disorientation
- Slurred speech
- Severe dizziness or loss of coordination
- Paradoxical reactions (e.g., increased anxiety, agitation, aggression, hallucinations)
- Signs of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have been diagnosed with glaucoma.
If you are currently taking any of the following medications: clarithromycin, itraconazole, or ketoconazole. Your doctor or pharmacist can provide guidance on other medications that should not be taken in combination with this drug.
If you are breastfeeding. It is recommended that you do not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have been diagnosed with glaucoma.
If you are currently taking any of the following medications: clarithromycin, itraconazole, or ketoconazole. Your doctor or pharmacist can provide guidance on other medications that should not be taken in combination with this drug.
If you are breastfeeding. It is recommended that you do not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
If you have been using this medication for an extended period or at high doses, you may develop tolerance, which means it may not work as effectively, and you may require higher doses to achieve the same effect. If you notice this medication is no longer working well, contact your doctor. Do not exceed the prescribed dose.
Until you understand how this medication affects you, avoid operating a vehicle or engaging in activities that require alertness. Additionally, refrain from consuming alcohol while taking this medication.
Before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your condition.
If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor, as it may interact with your medication.
If you have phenylketonuria (PKU), a condition where your body cannot break down the amino acid phenylalanine, consult with your doctor, as some products may contain phenylalanine.
If you start or stop smoking, inform your doctor, as your medication dosage may need to be adjusted.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
This medication may pose a risk to the unborn baby if taken during pregnancy. If you become pregnant or are planning to become pregnant while taking this medication, contact your doctor immediately. Taking this medication late in pregnancy may increase the risk of respiratory or feeding problems, low body temperature, or withdrawal symptoms in the newborn. Discuss the potential risks with your doctor.
If you have been using this medication for an extended period or at high doses, you may develop tolerance, which means it may not work as effectively, and you may require higher doses to achieve the same effect. If you notice this medication is no longer working well, contact your doctor. Do not exceed the prescribed dose.
Until you understand how this medication affects you, avoid operating a vehicle or engaging in activities that require alertness. Additionally, refrain from consuming alcohol while taking this medication.
Before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your condition.
If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor, as it may interact with your medication.
If you have phenylketonuria (PKU), a condition where your body cannot break down the amino acid phenylalanine, consult with your doctor, as some products may contain phenylalanine.
If you start or stop smoking, inform your doctor, as your medication dosage may need to be adjusted.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
This medication may pose a risk to the unborn baby if taken during pregnancy. If you become pregnant or are planning to become pregnant while taking this medication, contact your doctor immediately. Taking this medication late in pregnancy may increase the risk of respiratory or feeding problems, low body temperature, or withdrawal symptoms in the newborn. Discuss the potential risks with your doctor.
Overdose Information
Overdose Symptoms:
- Somnolence
- Confusion
- Impaired coordination
- Diminished reflexes
- Coma
- Respiratory depression (especially with co-ingestion of other CNS depressants)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Flumazenil may be used as an antidote but carries risks, especially in patients with benzodiazepine dependence or seizure disorders.
Drug Interactions
Major Interactions
- Opioids (increased risk of respiratory depression, profound sedation, coma, and death)
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, nefazodone, fluvoxamine, clarithromycin, ritonavir, atazanavir, indinavir, saquinavir, telithromycin)
- Other CNS depressants (e.g., alcohol, barbiturates, other benzodiazepines, sedating antihistamines, tricyclic antidepressants, antipsychotics, skeletal muscle relaxants)
Moderate Interactions
- Moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil, grapefruit juice)
- Digoxin (may increase digoxin levels)
- Imipramine, desipramine (may increase plasma concentrations of these TCAs)
- Oral contraceptives (may decrease alprazolam clearance)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Mental status/Anxiety symptoms
Rationale: To establish baseline severity and guide treatment.
Timing: Prior to initiation
Liver function tests (LFTs)
Rationale: Alprazolam is hepatically metabolized; baseline LFTs are important, especially in patients with suspected hepatic impairment.
Timing: Prior to initiation, if clinically indicated
Routine Monitoring
Efficacy (reduction in anxiety/panic symptoms)
Frequency: Regularly during dose titration and periodically thereafter
Target: Patient-specific improvement in symptoms with tolerable side effects
Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.
Adverse effects (e.g., sedation, dizziness, cognitive impairment, paradoxical reactions)
Frequency: Regularly, especially during initiation and dose changes
Target: Minimization of side effects
Action Threshold: Significant or intolerable side effects may require dose reduction or discontinuation.
Signs of tolerance, dependence, or withdrawal symptoms
Frequency: Periodically, especially with long-term use or during dose reduction/discontinuation
Target: Absence of these signs
Action Threshold: Presence of these signs requires careful management, including slow tapering.
Respiratory status (especially with concomitant opioid use)
Frequency: Closely monitor during co-administration
Target: Normal respiratory rate and depth
Action Threshold: Respiratory depression requires immediate intervention.
Symptom Monitoring
- Excessive sedation
- Dizziness
- Ataxia
- Confusion
- Memory impairment
- Slurred speech
- Paradoxical reactions (e.g., agitation, aggression, hallucinations)
- Signs of withdrawal (e.g., seizures, tremors, rebound anxiety, insomnia, irritability, muscle cramps, vomiting, sweating) upon discontinuation or dose reduction
Special Patient Groups
Pregnancy
Alprazolam is classified as Pregnancy Category D, meaning there is positive evidence of human fetal risk. It should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Increased risk of congenital malformations (e.g., cleft lip/palate) has been suggested in some studies, though data are conflicting.
Second Trimester:
Not well-studied, but continued exposure may lead to neonatal withdrawal symptoms.
Third Trimester:
Risk of neonatal flaccidity, respiratory depression, feeding difficulties, and withdrawal symptoms (e.g., irritability, hypertonia, tremors, diarrhea, vomiting) if used late in pregnancy.
Lactation
Alprazolam is excreted into breast milk. Due to potential for sedation, feeding difficulties, and withdrawal symptoms in the infant, use is generally not recommended. If use is necessary, monitor the infant closely for adverse effects.
Infant Risk:
L3 (Moderately safe) - Monitor infant for sedation, poor feeding, and weight gain. Consider alternative agents or temporary cessation of breastfeeding.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Use is generally not recommended due to potential for adverse effects and lack of data.
Geriatric Use
Elderly patients may be more sensitive to the effects of benzodiazepines, including increased risk of sedation, dizziness, falls, and cognitive impairment. Lower initial doses (e.g., 0.25 mg 2-3 times daily) and careful titration are recommended. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Alprazolam ODT offers a convenient dosage form for patients who have difficulty swallowing tablets or prefer a faster onset of action due to oral disintegration.
- Due to its relatively short half-life and potential for rapid onset, alprazolam has a higher potential for abuse, dependence, and withdrawal symptoms compared to longer-acting benzodiazepines.
- Always emphasize the importance of gradual tapering when discontinuing alprazolam to minimize withdrawal symptoms, which can be severe and include seizures.
- Educate patients about the risks of concomitant use with opioids and alcohol, highlighting the potential for life-threatening respiratory depression.
- Consider non-pharmacological interventions (e.g., cognitive behavioral therapy) as first-line or adjunctive treatment for anxiety and panic disorders.
Alternative Therapies
- Other Benzodiazepines (e.g., Lorazepam, Clonazepam, Diazepam)
- SSRIs (e.g., Sertraline, Paroxetine, Escitalopram) for anxiety and panic disorder (first-line for long-term management)
- SNRIs (e.g., Venlafaxine, Duloxetine) for anxiety disorders
- Buspirone (for generalized anxiety disorder)
- Hydroxyzine (for acute anxiety)
- Beta-blockers (e.g., Propranolol) for performance anxiety or physical symptoms of anxiety
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.