Buspirone 7.5mg 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
Serotonin 5-HT1A Receptor Partial Agonist; Dopamine D2 Receptor Antagonist (weak)
Pregnancy Category
Category B
FDA Approved
Sep 1986
DEA Schedule
Not Controlled
Overview
What is this medicine?
Buspirone is a medication used to treat generalized anxiety disorder (GAD). It works by affecting certain natural substances in the brain (neurotransmitters) that help regulate mood and anxiety. Unlike some other anxiety medications, it is not a benzodiazepine and is not typically associated with sedation or dependence.
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 your 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 your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who can also inform you about potential 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 your 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 your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who can also inform you about potential 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
- Take buspirone exactly as prescribed by your doctor, usually two or three times a day. It can be taken with or without food, but try to take it the same way each time (always with food or always without food) to keep levels consistent.
- Do not drink grapefruit juice or eat grapefruit while taking buspirone, as it can increase the amount of medication in your body and lead to more side effects.
- Avoid alcohol while taking buspirone, as it can increase drowsiness and dizziness.
- Buspirone does not work immediately; it may take 1 to 4 weeks to feel the full effects. Continue taking it regularly even if you don't feel better right away.
- Do not stop taking buspirone suddenly without talking to your doctor, as this can cause withdrawal-like symptoms, although less severe than with benzodiazepines.
- Be cautious when driving or operating machinery until you know how buspirone affects you, as it can cause dizziness or drowsiness.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
7.5 mg orally twice daily
Dose Range:
7.5 - 30 mg
Condition-Specific Dosing:
initial:
7.5 mg orally twice daily (15 mg/day)
titration:
Increase by 5 mg/day every 2-3 days as needed
maximum:
60 mg/day (divided doses)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in pediatric patients <18 years)
Adolescent:
Not established (Safety and efficacy not established in pediatric patients <18 years)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended
Moderate:
Use with caution; consider lower doses or less frequent dosing
Severe:
Use with caution; consider lower doses or less frequent dosing
Dialysis:
Not well studied; use with caution
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
Use with caution; consider lower doses or less frequent dosing
Severe:
Use with caution; consider lower doses or less frequent dosing
Pharmacology
Mechanism of Action
Buspirone's anxiolytic action is thought to be mediated through its activity as a partial agonist at presynaptic serotonin 5-HT1A receptors, which leads to a decrease in serotonergic neuronal firing and serotonin release. It also has a weaker antagonistic effect at postsynaptic dopamine D2 receptors. Unlike benzodiazepines, it does not directly affect GABAergic neurotransmission.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 4% (due to extensive first-pass metabolism)
Tmax:
0.4-1.5 hours
FoodEffect:
Food may increase bioavailability and decrease first-pass metabolism, leading to higher plasma concentrations. Administer consistently with or without food.
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 metabolite)
Clearance:
Not available
ExcretionRoute:
Renal (29-63%), Fecal (18-38%)
Unchanged:
Less than 1% (renal)
Pharmacodynamics
OnsetOfAction:
Gradual, typically 1-4 weeks for full therapeutic effect
PeakEffect:
Not applicable for acute effect; full therapeutic effect seen after several weeks of consistent dosing
DurationOfAction:
Not applicable for single dose; continuous effect with regular dosing
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 immediately or seek emergency 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, which may be more likely to occur if you are taking certain other medications. Warning signs include:
+ Agitation
+ Change in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Sweating excessively
+ Severe diarrhea, upset stomach, or vomiting
+ Severe headache
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. If you notice any of the following side effects, or if they bother you or do not go away, contact your doctor:
Feeling dizzy or sleepy
Feeling nervous and excitable
Headache
Upset stomach
This is not a comprehensive list of all possible 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.
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 immediately or seek emergency 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, which may be more likely to occur if you are taking certain other medications. Warning signs include:
+ Agitation
+ Change in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Sweating excessively
+ Severe diarrhea, upset stomach, or vomiting
+ Severe headache
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. If you notice any of the following side effects, or if they bother you or do not go away, contact your doctor:
Feeling dizzy or sleepy
Feeling nervous and excitable
Headache
Upset stomach
This is not a comprehensive list of all possible 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:
- Severe dizziness or lightheadedness
- Unusual excitement, restlessness, or agitation
- Fast or pounding heartbeat
- Muscle stiffness or twitching
- Fever, sweating, confusion (signs of serotonin syndrome)
- Numbness, tingling, or burning pain in hands or feet
- Blurred vision or other vision changes
- Rash or itching
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.
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, methylene blue, or tryptophan, as these medications may interact with this drug.
If you have kidney disease or liver disease, as these conditions may affect the way 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
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
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.
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, methylene blue, or tryptophan, as these medications may interact with this drug.
If you have kidney disease or liver disease, as these conditions may affect the way 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
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
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 alertness. 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. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
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. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe drowsiness
- Nausea
- Vomiting
- Dizziness
- Miosis (pinpoint pupils)
- Gastric distress
What to Do:
Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (risk of serotonin syndrome)
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, grapefruit juice) - significantly increase buspirone levels
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital) - significantly decrease buspirone levels
- Other serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, St. John's Wort) - increased risk of serotonin syndrome
Moderate Interactions
- Diltiazem, Verapamil (moderate CYP3A4 inhibitors) - may increase buspirone levels
- Erythromycin (moderate CYP3A4 inhibitor) - may increase buspirone levels
- Diazepam (may increase diazepam levels, though buspirone does not displace benzodiazepines from binding sites)
- Haloperidol (may increase haloperidol levels)
Minor Interactions
- Cimetidine (minor increase in buspirone levels)
Monitoring
Baseline Monitoring
Baseline anxiety symptoms assessment (e.g., GAD-7)
Rationale: To establish a baseline for evaluating treatment efficacy.
Timing: Prior to initiation of therapy
Renal and Hepatic function tests
Rationale: Buspirone is metabolized by the liver and excreted by the kidneys; impairment may require dose adjustment.
Timing: Prior to initiation of therapy, especially in patients with known or suspected impairment
Routine Monitoring
Anxiety symptom assessment
Frequency: Regularly (e.g., every 2-4 weeks during titration, then every 3-6 months)
Target: Reduction in symptom severity
Action Threshold: Lack of improvement or worsening symptoms may indicate need for dose adjustment or alternative therapy
Adverse effects monitoring (e.g., dizziness, nausea, headache, nervousness)
Frequency: Regularly, especially during initial titration and dose changes
Target: Tolerable side effect profile
Action Threshold: Intolerable side effects may require dose reduction or discontinuation
Symptom Monitoring
- Dizziness
- Nausea
- Headache
- Nervousness
- Lightheadedness
- Excitement
- Insomnia
- Drowsiness
- Fatigue
- Blurred vision
- Muscle pain
- Tingling/numbness (paresthesia)
- Serotonin syndrome symptoms (agitation, hallucinations, rapid heart rate, fever, sweating, shivering, muscle stiffness/twitching, loss of coordination, nausea, vomiting, diarrhea)
Special Patient Groups
Pregnancy
Buspirone is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
No increased risk of major birth defects observed in animal studies.
Second Trimester:
No specific risks identified.
Third Trimester:
No specific risks identified.
Lactation
Buspirone and its metabolites are excreted in human milk. The amount is small, but potential effects on the infant are unknown. The American Academy of Pediatrics considers buspirone to be of 'unknown effect on nursing infant'. Use with caution; monitor infant for drowsiness or other adverse effects. L3 (Moderately Safe).
Infant Risk:
Low to moderate risk; monitor for drowsiness, poor feeding, or developmental milestones.
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 18 years of age. Use is generally not recommended.
Geriatric Use
No specific dose adjustment is typically required based on age alone, but elderly patients may be more sensitive to the effects of buspirone due to potential age-related decreases in renal and hepatic function. Start with lower doses and titrate slowly, monitoring for adverse effects.
Clinical Information
Clinical Pearls
- Buspirone is not effective for acute anxiety attacks; its onset of action is gradual, taking 1-4 weeks for full therapeutic effect.
- It is a good alternative for patients who cannot tolerate or are at risk of dependence with benzodiazepines, as it lacks sedative, hypnotic, anticonvulsant, and muscle relaxant properties.
- Patients transitioning from benzodiazepines to buspirone should be tapered off the benzodiazepine slowly, as buspirone does not prevent benzodiazepine withdrawal symptoms.
- Consistency in administration (always with food or always without food) is important due to the food effect on bioavailability.
- Avoid grapefruit juice due to significant CYP3A4 inhibition, which can lead to increased buspirone levels and side effects.
- Monitor for serotonin syndrome, especially if co-administered with other serotonergic agents.
Alternative Therapies
- Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g., escitalopram, sertraline, paroxetine)
- Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) (e.g., venlafaxine, duloxetone)
- Benzodiazepines (e.g., alprazolam, lorazepam, clonazepam) - for short-term or acute anxiety
- Hydroxyzine
- Pregabalin
- Cognitive Behavioral Therapy (CBT)
- Other psychotherapies
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets (7.5mg)
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. 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 occurred.