Buspirone 30mg 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. It works by affecting certain natural substances in the brain. Unlike some other anxiety medications, it is not a benzodiazepine and does not typically cause sedation or dependence in the same way. 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 always take it with food or always take it on an empty stomach to maintain consistency.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel well. Some tablets may have a score line, which allows them to be split into two equal parts if needed.
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. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult with 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. Avoid taking two doses at the same time or taking extra doses.
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 always take it with food or always take it on an empty stomach to maintain consistency.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel well. Some tablets may have a score line, which allows them to be split into two equal parts if needed.
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. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult with 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. Avoid taking two doses at the same time or taking extra doses.
Lifestyle & Tips
- Take buspirone consistently at the same time each day, with or without food, but consistently (e.g., always with food or always without food) to maintain consistent absorption.
- Avoid drinking grapefruit juice or eating grapefruit while taking buspirone, as it can increase the amount of medication in your body and lead to more side effects.
- Avoid alcohol, as it can increase drowsiness and dizziness.
- Do not drive or operate heavy machinery until you know how buspirone affects you, as it can cause dizziness or drowsiness.
- Do not stop taking buspirone suddenly without talking to your doctor, even though it is not associated with the same withdrawal symptoms as benzodiazepines, your anxiety symptoms may return.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
15 mg/day in 2-3 divided doses, typically 7.5 mg twice daily or 5 mg three times daily.
Dose Range:
15 - 60 mg
Condition-Specific Dosing:
initialDose:
7.5 mg twice daily or 5 mg three times daily
titration:
Increase by 5 mg/day every 2-3 days as needed
maximumDose:
60 mg/day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for generalized anxiety disorder (GAD) in children under 18 years.
Adolescent:
Not established for generalized anxiety disorder (GAD) in adolescents under 18 years.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
Use with caution; consider lower doses and close monitoring.
Severe:
Avoid use or use with extreme caution at significantly reduced doses (e.g., 2.5 mg BID initially), due to increased plasma levels of buspirone and its active metabolite. Close monitoring is essential.
Dialysis:
Not well studied; buspirone is highly protein-bound, so dialysis is unlikely to be effective in removing it. Avoid use or use with extreme caution.
Hepatic Impairment:
Mild:
Use with caution; consider lower doses.
Moderate:
Use with caution; consider lower doses (e.g., 2.5 mg BID initially) and close monitoring due to increased plasma levels of buspirone and its active metabolite.
Severe:
Avoid use or use with extreme caution at significantly reduced doses (e.g., 2.5 mg BID initially), due to substantial increase in plasma levels. Close monitoring is essential.
Pharmacology
Mechanism of Action
Buspirone is an anxiolytic agent that is not chemically or pharmacologically related to benzodiazepines, barbiturates, or other sedative/hypnotic drugs. Its anxiolytic action is believed to be mediated through its activity as a partial agonist at serotonin 5-HT1A receptors in the brain. It also has a weak antagonist effect at presynaptic dopamine D2 receptors. Unlike benzodiazepines, buspirone does not directly affect GABAergic neurotransmission.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 4% (due to extensive first-pass metabolism)
Tmax:
0.9-1.5 hours
FoodEffect:
Food increases the bioavailability (AUC) of buspirone and decreases the rate of absorption (delays Tmax).
Distribution:
Vd:
Approximately 5.3 L/kg
ProteinBinding:
Approximately 95% (primarily to plasma proteins)
CnssPenetration:
Yes (acts centrally, but does not cause significant CNS depression like benzodiazepines)
Elimination:
HalfLife:
Approximately 2-3 hours (buspirone); 4.8-11 hours (1-PP)
Clearance:
Not precisely quantified as a single rate, but rapid hepatic clearance.
ExcretionRoute:
Renal (29-63%), Fecal (18-38%)
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Anxiolytic effects typically begin within 1-4 weeks of continuous therapy; not suitable for acute anxiety attacks.
PeakEffect:
Full therapeutic effect may take 3-4 weeks.
DurationOfAction:
Requires multiple daily doses due to short half-life.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 medical help right away:
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 take 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
+ Sweating excessively
+ 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 notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Feeling dizzy or sleepy
Feeling nervous and excitable
Headache
Upset stomach
This is not an exhaustive list of 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 or seek medical help right away:
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 take 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
+ Sweating excessively
+ 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 notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Feeling dizzy or sleepy
Feeling nervous and excitable
Headache
Upset stomach
This is not an exhaustive list of 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
- Extreme drowsiness or sedation
- Unusual excitement, restlessness, or agitation
- Numbness, tingling, or burning pain in hands or feet (paresthesia)
- Blurred vision
- Muscle weakness or incoordination
- Symptoms of serotonin syndrome: agitation, hallucinations, rapid heart rate, fever, sweating, shivering, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea (seek immediate medical attention)
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 increase the risk of 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 complete medical history, including any health problems you have
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 conjunction 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 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 increase the risk of 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 complete medical history, including any health problems you have
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 conjunction with this medication.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To ensure your safety, avoid operating a vehicle or engaging in activities that require alertness until you understand how this medication affects you. Additionally, refrain from consuming alcohol while taking this drug, as it may exacerbate its effects.
Before using marijuana, other forms of cannabis, or taking prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor to discuss potential interactions. If you regularly consume grapefruit juice or eat grapefruit, inform your doctor, as this may impact the medication's efficacy.
As this medication may influence the results of certain laboratory tests, notify all healthcare providers and laboratory personnel that you are taking this drug.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult with your doctor to discuss the potential benefits and risks associated with this medication, both for you and your baby.
To ensure your safety, avoid operating a vehicle or engaging in activities that require alertness until you understand how this medication affects you. Additionally, refrain from consuming alcohol while taking this drug, as it may exacerbate its effects.
Before using marijuana, other forms of cannabis, or taking prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor to discuss potential interactions. If you regularly consume grapefruit juice or eat grapefruit, inform your doctor, as this may impact the medication's efficacy.
As this medication may influence the results of certain laboratory tests, notify all healthcare providers and laboratory personnel that you are taking this drug.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult with your doctor to discuss the potential benefits and risks associated with this medication, both for you and your baby.
Overdose Information
Overdose Symptoms:
- Severe drowsiness
- Nausea
- Vomiting
- Dizziness
- Miosis (pinpoint pupils)
What to Do:
Call 911 or your local emergency number immediately. For poison control, call 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 hypertensive crisis or serotonin syndrome)
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, nefazodone, grapefruit juice) - significantly increase buspirone levels, leading to increased side effects. Dose reduction of buspirone may be necessary.
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital) - significantly decrease buspirone levels, reducing efficacy.
Moderate Interactions
- Other serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, St. John's Wort) - theoretical risk of serotonin syndrome, though lower than with MAOIs.
- CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedating antihistamines) - while buspirone does not significantly potentiate CNS depression, caution is advised.
- Verapamil, Diltiazem (moderate CYP3A4 inhibitors) - may increase buspirone levels.
Minor Interactions
- Erythromycin (moderate CYP3A4 inhibitor) - may increase buspirone levels.
- Cimetidine - may slightly increase buspirone levels.
Monitoring
Baseline Monitoring
Renal function (BUN, creatinine)
Rationale: To assess baseline kidney function, especially if impairment is suspected, as buspirone and its metabolite are renally excreted.
Timing: Prior to initiation in patients with suspected renal impairment.
Hepatic function (ALT, AST, bilirubin)
Rationale: To assess baseline liver function, as buspirone is extensively metabolized by the liver.
Timing: Prior to initiation in patients with suspected hepatic impairment.
Routine Monitoring
Anxiety symptom severity (e.g., GAD-7 score)
Frequency: Periodically (e.g., every 2-4 weeks initially, then every 3-6 months)
Target: Reduction in symptom score, improved functional status
Action Threshold: Lack of improvement after adequate trial (4-6 weeks at target dose) or worsening symptoms may indicate need for dose adjustment or alternative therapy.
Side effects (e.g., dizziness, nausea, headache, nervousness)
Frequency: At each visit, especially during dose titration
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
- Paresthesia
- Tinnitus
- Rash
- Serotonin syndrome symptoms (agitation, hallucinations, rapid heart rate, fever, overactive reflexes, nausea, vomiting, diarrhea, incoordination)
Special Patient Groups
Pregnancy
Buspirone is 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 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; generally considered low risk based on available information, but caution advised.
Third Trimester:
Limited human data; generally considered low risk based on available information, but caution advised. No known neonatal withdrawal syndrome like with benzodiazepines.
Lactation
Buspirone and its metabolites are excreted in human milk. The amount is small, and adverse effects in breastfed infants are unlikely but possible. Monitor the infant for drowsiness, poor feeding, or developmental milestones. Use with caution; consider alternative agents or weigh risks/benefits.
Infant Risk:
L3 (Moderately Safe) - Monitor infant for sedation, poor feeding, or irritability. Risk of adverse effects appears low based on limited data.
Pediatric Use
Safety and effectiveness in pediatric patients (under 18 years of age) have not been established for the treatment of generalized anxiety disorder. Studies in pediatric patients with GAD did not demonstrate efficacy.
Geriatric Use
No specific dose adjustment is recommended based on age alone, but elderly patients may be more sensitive to the effects of buspirone due to age-related decreases in renal and hepatic function. Start with lower doses (e.g., 5 mg BID) and titrate slowly, monitoring closely for adverse effects such as dizziness or sedation.
Clinical Information
Clinical Pearls
- Buspirone is not a benzodiazepine and does not cause physical dependence or withdrawal symptoms associated with benzodiazepines. It is a good option for patients with a history of substance abuse.
- It is not effective for acute anxiety attacks or panic disorder; its anxiolytic effects develop gradually over several weeks.
- Patients should be advised that they will not feel an immediate effect and that consistent daily dosing is crucial for efficacy.
- Avoid grapefruit juice due to significant CYP3A4 inhibition, which can increase buspirone levels and side effects.
- Buspirone does not significantly potentiate the effects of alcohol or other CNS depressants, unlike benzodiazepines, but caution is still advised.
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, but with higher risk of dependence and sedation.
- Hydroxyzine (antihistamine with anxiolytic properties)
- Pregabalin (for GAD in some regions, not FDA approved for GAD in US)
- Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (generic)
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 happened.