Buspirone 15mg 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
Azaspirodecanedione; 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 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 immediate relief, 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 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
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe 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 by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or look into 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
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe 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 by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or look into 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 consistently at the same time each day, with or without food, but be consistent (always with food or always without food).
- Avoid drinking large amounts of grapefruit juice while taking this medication, as it can increase buspirone levels.
- Avoid alcohol, as it may increase side effects like dizziness or drowsiness.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it may cause dizziness or lightheadedness.
- Do not stop taking buspirone suddenly without consulting your doctor, even though it is not associated with significant withdrawal symptoms like benzodiazepines, your anxiety symptoms may 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.
Dose Range:
15 - 60 mg
Condition-Specific Dosing:
maintenance:
15 mg to 30 mg per day in 2 or 3 divided doses. Maximum daily dose is 60 mg.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established for GAD in pediatric patients)
Adolescent:
Not established (Safety and efficacy not established for GAD in pediatric patients)
Dose Adjustments
Renal Impairment:
Mild:
Use with caution
Moderate:
Use with caution, consider lower doses
Severe:
Use with caution, consider lower doses or avoid
Dialysis:
Not available (Buspirone is extensively metabolized, dialysis unlikely to be effective)
Hepatic Impairment:
Mild:
Use with caution
Moderate:
Use with caution, consider lower doses
Severe:
Use with caution, consider lower doses or avoid
Confidence:
Medium
Pharmacology
Mechanism of Action
Buspirone's anxiolytic action is thought to be mediated through its activity as a partial agonist at serotonin 5-HT1A receptors. It also has some affinity for dopamine D2 receptors. Unlike benzodiazepines, it does not directly affect GABAergic systems.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 4% (due to extensive first-pass metabolism)
Tmax:
0.9 to 1.5 hours
FoodEffect:
Food increases AUC and Cmax, and decreases Cmax variability.
Distribution:
Vd:
5.3 L/kg
ProteinBinding:
Approximately 95% (primarily to plasma albumin and alpha-1 acid glycoprotein)
CnssPenetration:
Yes (acts centrally)
Elimination:
HalfLife:
Parent drug: 2-3 hours; Active metabolite (1-PP): 4.8-11 hours
Clearance:
Not available (highly variable)
ExcretionRoute:
Renal (29-63%), Fecal (18-38%)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Gradual, typically 1-4 weeks for full therapeutic effect
PeakEffect:
Not applicable for acute effect; peak therapeutic effect is gradual over weeks
DurationOfAction:
Not applicable for acute effect; chronic treatment
Confidence:
Medium
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 immediately 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, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Dizziness or drowsiness
Feeling nervous and excitable
Headache
Upset stomach
Reporting Side Effects
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact 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 immediately 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, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Dizziness or drowsiness
Feeling nervous and excitable
Headache
Upset stomach
Reporting Side Effects
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact 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:
- Signs of Serotonin Syndrome: agitation, hallucinations, rapid heart rate, fever, sweating, shivering, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea.
- Severe dizziness or fainting.
- Unusual thoughts or behavior.
- New or worsening depression or suicidal thoughts.
- Allergic reaction: rash, itching/swelling (especially of face/tongue/throat), 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 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, 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 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
Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so in combination with 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 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, 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 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
Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so in combination with 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 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, grapefruit juice) - significantly increase buspirone levels
- Strong CYP3A4 inducers (e.g., rifampin) - 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
- Moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil, erythromycin) - may increase buspirone levels
- Drugs that affect CNS (e.g., alcohol, other sedatives) - additive CNS depression (though buspirone has minimal sedative effects compared to benzodiazepines)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Anxiety symptom assessment (e.g., Hamilton Anxiety Rating Scale)
Rationale: To establish baseline severity and track treatment response.
Timing: Prior to initiation of therapy
Renal function (BUN, creatinine)
Rationale: Buspirone is partially renally excreted; caution in renal impairment.
Timing: Prior to initiation, especially if pre-existing renal impairment
Hepatic function (ALT, AST, bilirubin)
Rationale: Buspirone is extensively metabolized by the liver; caution in hepatic impairment.
Timing: Prior to initiation, especially if pre-existing hepatic impairment
Routine Monitoring
Anxiety symptom improvement
Frequency: Weekly for first few weeks, then monthly or as clinically indicated
Target: Reduction in symptom severity
Action Threshold: Lack of improvement after 4-6 weeks at adequate dose may indicate need for dose adjustment or alternative therapy
Side effects (e.g., dizziness, nausea, headache, nervousness)
Frequency: Regularly, especially during dose titration and initial weeks
Target: Tolerable levels
Action Threshold: Intolerable side effects may require dose reduction or discontinuation
Signs/symptoms of Serotonin Syndrome (e.g., agitation, hallucinations, tachycardia, fever, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
Frequency: Ongoing, especially if co-administered with other serotonergic drugs
Target: Absence of symptoms
Action Threshold: Immediate medical attention if symptoms occur
Symptom Monitoring
- Anxiety levels (e.g., worry, tension, restlessness)
- Sleep patterns
- Irritability
- Concentration difficulties
- Physical symptoms of anxiety (e.g., muscle tension, palpitations, shortness of breath)
- Dizziness
- Nausea
- Headache
- Nervousness
- Lightheadedness
- Insomnia
Special Patient Groups
Pregnancy
Buspirone is Pregnancy Category B. Animal studies have shown no evidence of impaired fertility or harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed and the potential benefits outweigh the potential risks.
Trimester-Specific Risks:
First Trimester:
Limited human data, animal studies show no teratogenicity. Use only if clearly indicated.
Second Trimester:
Limited human data, use with caution.
Third Trimester:
Limited human data, use with caution. Consider potential for neonatal withdrawal symptoms if used close to delivery, though less likely than with benzodiazepines.
Lactation
Buspirone and its metabolites are excreted in human milk. The amount is small, but potential for adverse effects on the infant exists. The decision to breastfeed should consider the importance of the drug to the mother, the risk of infant exposure, and the risk of untreated maternal condition. Lactation risk category L3 (Moderately Safe).
Infant Risk:
Potential for drowsiness, poor feeding, or other CNS effects in the infant. Monitor infant for adverse effects.
Pediatric Use
Safety and efficacy have not been established in pediatric patients for the treatment of Generalized Anxiety Disorder (GAD). Use in children is generally not recommended for GAD. Some off-label use has been explored for other conditions, but evidence is limited.
Geriatric Use
No specific dose adjustment is required based solely on age, but elderly patients may be more sensitive to the effects of buspirone. Start with lower doses and titrate slowly, monitoring for dizziness and other CNS side effects. Renal and hepatic function should be considered.
Clinical Information
Clinical Pearls
- Buspirone is not a benzodiazepine and does not have the same potential for physical dependence or withdrawal symptoms. It is not effective for acute anxiety attacks.
- Full therapeutic effects may take 1-4 weeks to develop, so patients should be counseled on this delayed onset.
- It does not cause significant sedation or cognitive impairment compared to benzodiazepines, making it a suitable option for patients who need to remain alert.
- Avoid grapefruit juice due to significant CYP3A4 inhibition, which can increase buspirone levels and side effects.
- Can be used as an alternative or adjunct to SSRIs/SNRIs for anxiety, especially if patients experience sexual dysfunction or sedation with other agents.
- 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 (e.g., alprazolam, lorazepam, clonazepam - for short-term or acute anxiety)
- Hydroxyzine
- Beta-blockers (e.g., propranolol - for performance anxiety or physical symptoms)
- Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (generic 15mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.