Buspirone 10mg Tablets
It is used to treat anxiety.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anxiolytic
Pharmacologic Class
Azapirone; Serotonin 5-HT1A Receptor Partial Agonist
Pregnancy Category
Category B
FDA Approved
Sep 1986
DEA Schedule
Not Controlled
Overview
What is this medicine?
Buspirone is a medication used to treat anxiety. Unlike some other anxiety medications, it is not a benzodiazepine and does not cause sedation or physical dependence in the same way. It works by affecting certain natural substances in the brain. It takes time to work, so you won't feel an immediate effect, and it's important to take it regularly as prescribed.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, but it's essential to take it the same way each time. Choose to take it either always with food or always on an empty stomach to maintain consistency.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well. Some tablets may have a score line, which allows you to split them if needed. However, only split the tablets along the score line.
Storing and Disposing of Your Medication
To keep your medication effective and safe, store it at room temperature in a dry place, avoiding the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, but it's essential to take it the same way each time. Choose to take it either always with food or always on an empty stomach to maintain consistency.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well. Some tablets may have a score line, which allows you to split them if needed. However, only split the tablets along the score line.
Storing and Disposing of Your Medication
To keep your medication effective and safe, store it at room temperature in a dry place, avoiding the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Avoid consuming large amounts of grapefruit or grapefruit juice while taking buspirone, as it can increase the drug's levels in your body and lead to more side effects.
- Avoid alcohol, as it may increase drowsiness or dizziness.
- Do not drive or operate heavy machinery until you know how buspirone affects you, as it can cause dizziness or drowsiness.
- Take the medication consistently, either always with food or always without food, to maintain consistent absorption.
- Do not stop taking buspirone suddenly without consulting your doctor, even though it has a low risk of withdrawal compared to benzodiazepines, your anxiety symptoms could return.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 7.5 mg orally twice daily. May increase by 5 mg/day every 2-3 days. Usual therapeutic dose: 15-30 mg/day in 2-3 divided doses.
Dose Range:
15 - 60 mg
Condition-Specific Dosing:
generalized_anxiety_disorder:
Initial: 7.5 mg orally twice daily. May increase by 5 mg/day every 2-3 days. Usual therapeutic dose: 15-30 mg/day in 2-3 divided doses. Maximum: 60 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established for GAD in pediatric patients <18 years)
Adolescent:
Not established (Safety and efficacy not established for GAD in pediatric patients <18 years)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
Use with caution; consider lower doses and monitor closely. Buspirone is extensively metabolized and excreted renally.
Dialysis:
Not available (Data lacking; use with caution)
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
Use with caution; consider lower doses and monitor closely. Buspirone is extensively metabolized by the liver.
Severe:
Use with caution; consider lower doses and monitor closely. Buspirone is extensively metabolized by the liver.
Pharmacology
Mechanism of Action
Buspirone is an azapirone anxiolytic that exerts its anxiolytic effects primarily through its partial agonist activity at presynaptic serotonin 5-HT1A receptors. It also has a weaker affinity for dopamine D2 receptors, acting as an antagonist. Unlike benzodiazepines, buspirone does not directly affect GABAergic systems, which contributes to its lack of sedative, hypnotic, anticonvulsant, or muscle relaxant properties, and a lower potential for physical dependence.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 4% (due to extensive first-pass metabolism)
Tmax:
0.4-1.5 hours
FoodEffect:
Food increases bioavailability (AUC) and decreases peak plasma concentrations (Cmax), but delays Tmax. Administration with food may reduce first-pass metabolism.
Distribution:
Vd:
5.3 L/kg
ProteinBinding:
Approximately 95% (primarily to plasma proteins)
CnssPenetration:
Yes
Elimination:
HalfLife:
2-3 hours (parent drug); 4.8-11 hours (1-PP)
Clearance:
Not available
ExcretionRoute:
Renal (29-63%), Fecal (18-38%)
Unchanged:
Less than 1% (renal excretion of unchanged drug)
Pharmacodynamics
OnsetOfAction:
Delayed (typically 1-4 weeks for full therapeutic effect)
PeakEffect:
Not applicable (gradual onset)
DurationOfAction:
Not applicable (chronic use for sustained effect)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while 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
Restlessness
Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking
Serotonin syndrome, a severe and potentially deadly condition, may occur, especially if you are taking certain other medications. Seek medical help right away if you experience:
+ Agitation
+ Change in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, upset stomach, or vomiting
+ Severe headache
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:
Feeling dizzy or sleepy
Feeling nervous and excitable
Headache
Upset stomach
This is not an exhaustive list of possible side effects. If you have concerns or questions 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.
Although rare, some people may experience severe and potentially life-threatening side effects while 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
Restlessness
Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking
Serotonin syndrome, a severe and potentially deadly condition, may occur, especially if you are taking certain other medications. Seek medical help right away if you experience:
+ Agitation
+ Change in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, upset stomach, or vomiting
+ Severe headache
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:
Feeling dizzy or sleepy
Feeling nervous and excitable
Headache
Upset stomach
This is not an exhaustive list of possible side effects. If you have concerns or questions 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:
- Severe dizziness or lightheadedness
- Unusual excitement, restlessness, or agitation
- Fast or irregular heartbeat
- Muscle stiffness or twitching
- Fever, sweating, confusion (signs of serotonin syndrome, especially if taking other serotonergic drugs)
- Rash or hives
- Difficulty breathing or swallowing
- Any new or worsening anxiety or depression
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 symptoms you experienced.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to very high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.
If you are taking tryptophan, as it may interact with this medication.
If you have kidney disease or liver disease, as these conditions may affect how your body processes this medication.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your health problems, including any medical conditions or diseases
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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 symptoms you experienced.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to very high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.
If you are taking tryptophan, as it may interact with this medication.
If you have kidney disease or liver disease, as these conditions may affect how your body processes this medication.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your health problems, including any medical conditions or diseases
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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. Until you understand how this drug affects you, avoid operating a vehicle and engaging in other activities that require your full attention. Additionally, refrain from consuming alcohol while taking this medication.
Before using marijuana, other cannabis products, or prescription and over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor. If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor, as it may interact with this medication.
Be aware that this drug may influence the results of certain laboratory tests. Therefore, notify all your healthcare providers and laboratory personnel that you are taking this medication.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Before using marijuana, other cannabis products, or prescription and over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor. If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor, as it may interact with this medication.
Be aware that this drug may influence the results of certain laboratory tests. Therefore, notify all your healthcare providers and laboratory personnel that you are taking this medication.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- Severe drowsiness
- Nausea
- Vomiting
- Dizziness
- Miosis (pinpoint pupils)
- Gastric distress
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic. There is no specific antidote.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, erythromycin, nefazodone, diltiazem, verapamil, grapefruit juice) - significantly increase buspirone plasma concentrations, increasing risk of adverse effects.
- Strong CYP3A4 inducers (e.g., rifampin, phenobarbital, phenytoin, carbamazepine) - significantly decrease buspirone plasma concentrations, reducing efficacy.
Moderate Interactions
- Other CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedating antihistamines) - may potentiate CNS depression, though less than with benzodiazepines.
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, St. John's Wort) - theoretical risk of serotonin syndrome, though less common than with other serotonergic agents.
- Digoxin - buspirone may increase digoxin levels (mechanism unclear).
Minor Interactions
- Warfarin - minor changes in prothrombin time reported, monitor INR.
Monitoring
Baseline Monitoring
Clinical assessment of anxiety symptoms
Rationale: To establish baseline severity and guide treatment initiation.
Timing: Prior to initiation of therapy
Medical history (including psychiatric and substance use history)
Rationale: To identify contraindications, potential drug interactions, and suitability for buspirone therapy.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical assessment of anxiety symptoms (e.g., GAD-7 score)
Frequency: Weekly for first 2-4 weeks, then monthly or as clinically indicated
Target: Reduction in symptom severity
Action Threshold: Lack of improvement or worsening symptoms after adequate trial (4-6 weeks at therapeutic dose) may warrant dose adjustment or alternative therapy.
Monitoring for adverse effects (e.g., dizziness, nausea, headache, nervousness)
Frequency: Regularly, especially during dose titration and initial weeks of therapy
Target: Absence or tolerability of side effects
Action Threshold: Intolerable or severe adverse effects may require dose reduction or discontinuation.
Symptom Monitoring
- Reduction in excessive worry
- Decrease in restlessness
- Improvement in fatigue
- Reduction in difficulty concentrating
- Decrease in irritability
- Improvement in muscle tension
- Reduction in sleep disturbance
- Dizziness
- Nausea
- Headache
- Nervousness
- Lightheadedness
- Insomnia
- Drowsiness
Special Patient Groups
Pregnancy
Buspirone is Pregnancy Category B, meaning animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. It is generally considered a safer option than benzodiazepines for anxiety during pregnancy, but use only if clearly needed and potential benefits outweigh risks.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data; human data limited but generally reassuring.
Second Trimester:
Low risk based on animal data; human data limited but generally reassuring.
Third Trimester:
Low risk based on animal data; human data limited but generally reassuring.
Lactation
Buspirone and its metabolites are excreted in human milk. The amount is small, but potential effects on the infant are unknown. Use with caution; consider alternative therapies or monitor infant for drowsiness, poor feeding, or developmental milestones. The American Academy of Pediatrics considers buspirone's effect on nursing infants unknown but may be of concern.
Infant Risk:
L3 (Moderately Safe - limited data, potential for minor adverse effects; weigh risk vs. benefit)
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 18 years of age for generalized anxiety disorder. Use is generally not recommended.
Geriatric Use
No specific dose adjustment is required based on age alone, but elderly patients may be more sensitive to the effects of buspirone. Start with lower doses (e.g., 5 mg twice daily) and titrate slowly, monitoring closely for adverse effects such as dizziness or cognitive impairment.
Clinical Information
Clinical Pearls
- Buspirone is not effective for acute anxiety attacks; it is for chronic, generalized anxiety disorder.
- It has a delayed onset of action (1-4 weeks for full effect), so patients should be counseled on this to manage expectations.
- Unlike benzodiazepines, buspirone does not cause significant sedation, cognitive impairment, or physical dependence/withdrawal symptoms.
- It can be a good alternative for patients who cannot tolerate or wish to avoid benzodiazepines.
- Avoid grapefruit juice due to significant CYP3A4 inhibition, which can increase buspirone levels and side effects.
- Patients transitioning from benzodiazepines to buspirone should be tapered off the benzodiazepine slowly, as buspirone does not prevent benzodiazepine withdrawal symptoms.
Alternative Therapies
- Selective Serotonin Reuptake Inhibitors (SSRIs) - e.g., escitalopram, sertraline, paroxetine
- Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) - e.g., venlafaxine, duloxetine
- Benzodiazepines (for short-term or acute anxiety, but with higher risk of dependence) - e.g., alprazolam, lorazepam, clonazepam
- Hydroxyzine (antihistamine with anxiolytic properties)
- Pregabalin (for GAD in some regions)
- Cognitive Behavioral Therapy (CBT) and other psychotherapies
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets (10mg generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for 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. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.