Buspirone 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
Pregnancy 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 typically cause sedation or physical dependence. It works by affecting certain natural substances in the brain. It takes time to work, so you won't feel its full effects right away, usually several weeks.
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 exactly as prescribed, usually two or three times a day. Do not take more or less than directed.
- Take buspirone consistently with or without food (e.g., always with food or always without food) to maintain consistent absorption.
- Avoid drinking grapefruit juice or eating grapefruit while taking this medication, as it can increase the amount of buspirone in your body and lead to more side effects.
- Avoid alcohol and other CNS depressants, as they may increase drowsiness or dizziness, although buspirone itself is not a strong sedative.
- Do not stop taking buspirone suddenly without talking to your doctor, even though it is not associated with physical dependence like benzodiazepines, your anxiety symptoms may return.
- Buspirone is not for 'as-needed' use or for acute anxiety attacks; it must be taken regularly for its full effect.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
7.5 mg orally twice daily, or 5 mg orally three times daily
Dose Range:
10 - 60 mg
Condition-Specific Dosing:
initialDose:
7.5 mg orally twice daily (15 mg/day)
titration:
Increase by 5 mg/day every 2-3 days as needed
maintenance:
Usually 20-30 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 generalized anxiety disorder in children <18 years)
Adolescent:
Not established (Safety and efficacy not established for generalized anxiety disorder in children <18 years)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
Use with caution; consider lower doses and monitor for adverse effects.
Severe:
Use with caution; consider lower doses and monitor for adverse effects. Avoid if possible.
Dialysis:
Not available (Limited data; use with caution and monitor)
Hepatic Impairment:
Mild:
Use with caution; consider lower doses and monitor for adverse effects.
Moderate:
Use with caution; consider lower doses and monitor for adverse effects. Avoid if possible.
Severe:
Avoid use due to significantly impaired metabolism and increased exposure.
Pharmacology
Mechanism of Action
Buspirone's anxiolytic action is believed to be mediated through its high affinity for serotonin 5-HT1A receptors, where it acts as a partial agonist. It also has moderate affinity for dopamine D2 receptors and no significant affinity for benzodiazepine-GABA receptors. Unlike benzodiazepines, buspirone does not produce sedative, hypnotic, or muscle relaxant effects, nor does it cause physical dependence or withdrawal symptoms.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 4% (due to extensive first-pass metabolism)
Tmax:
0.4 to 1.5 hours
FoodEffect:
Food increases the bioavailability (AUC and Cmax) of buspirone, but the clinical significance is unclear. It is generally recommended to take buspirone consistently with or without food.
Distribution:
Vd:
Approximately 5.3 L/kg
ProteinBinding:
Approximately 95% (primarily to plasma proteins)
CnssPenetration:
Yes (though limited, it acts centrally)
Elimination:
HalfLife:
Approximately 2-3 hours (parent drug); 4.8-11 hours (1-PP)
Clearance:
Not available (Highly variable due to first-pass effect)
ExcretionRoute:
Renal (29-63%) and Fecal (18-38%)
Unchanged:
Less than 1% (renal excretion)
Pharmacodynamics
OnsetOfAction:
Gradual, typically 1-4 weeks for full therapeutic effect
PeakEffect:
Not applicable (gradual onset)
DurationOfAction:
Not applicable (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 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
Most people do not experience severe side effects, and many have no side effects or only minor ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
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
Most people do not experience severe side effects, and many have no side effects or only minor ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
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:
- Signs of Serotonin Syndrome: agitation, hallucinations, confusion, rapid heart rate, fever, sweating, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea.
- Severe dizziness or lightheadedness.
- Unusual excitement or restlessness.
- New or worsening anxiety, panic attacks, insomnia, irritability, hostility, impulsivity, or suicidal thoughts/behavior (especially at the beginning of treatment or with dose changes).
- Allergic reaction symptoms: 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 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 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 complete medical history, including any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, you must 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 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 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 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 complete medical history, including any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, you must 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 or engaging in 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. 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, nefazodone, grapefruit juice) - significantly increase buspirone levels, increasing risk of adverse effects.
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital) - significantly decrease buspirone levels, reducing efficacy.
- Other serotonergic drugs (e.g., SSRIs, SNRIs, triptans, TCAs, fentanyl, lithium, St. John's Wort, tramadol) - increased risk of serotonin syndrome.
Moderate Interactions
- Digoxin (buspirone may increase digoxin levels)
- Warfarin (potential for increased prothrombin time/INR, though not consistently reported)
- Diazepam (increased diazepam levels, though not clinically significant for buspirone efficacy)
- Haloperidol (increased haloperidol levels)
- Erythromycin (increased buspirone levels)
- Verapamil (increased buspirone levels)
Minor Interactions
- Not available (most interactions are moderate to major due to CYP3A4 metabolism or pharmacodynamic effects)
Monitoring
Baseline Monitoring
Anxiety symptom severity (e.g., Hamilton Anxiety Rating Scale)
Rationale: To establish baseline and track treatment response.
Timing: Prior to initiation of therapy
Renal and Hepatic Function Tests (e.g., BUN, creatinine, ALT, AST)
Rationale: To assess for pre-existing impairment that may necessitate dose adjustment or contraindicate use.
Timing: Prior to initiation, especially in patients with suspected impairment
Routine Monitoring
Anxiety symptom improvement and adverse effects
Frequency: Regularly during dose titration and periodically during maintenance (e.g., every 2-4 weeks initially, then every 3-6 months)
Target: Reduction in anxiety symptoms, improved daily functioning, tolerable side effect profile.
Action Threshold: Lack of improvement after adequate trial (4-6 weeks at target dose), intolerable side effects, or emergence of new/worsening symptoms.
Signs of Serotonin Syndrome (e.g., agitation, hallucinations, tachycardia, fever, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
Frequency: Continuously, especially when co-administered with other serotonergic agents.
Target: Absence of symptoms.
Action Threshold: Immediate discontinuation of buspirone and other serotonergic agents, and supportive care.
Symptom Monitoring
- Dizziness
- Nausea
- Headache
- Nervousness
- Lightheadedness
- Excitement
- Insomnia
- Drowsiness
- Blurred vision
- Dry mouth
- Fatigue
- Serotonin syndrome symptoms (agitation, confusion, rapid heart rate, fever, muscle rigidity, sweating, diarrhea)
Special Patient Groups
Pregnancy
Buspirone is Pregnancy Category B. Studies in animals have not shown a risk 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. Continue if benefits outweigh risks.
Third Trimester:
Limited human data. Consider potential for neonatal withdrawal symptoms (though less likely than with benzodiazepines) if used close to delivery.
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's effect on nursing infants as 'unknown but may be of concern'. Weigh the developmental and health benefits of breastfeeding along with the mother's clinical need for buspirone and any potential adverse effects on the breastfed infant from buspirone or from the underlying maternal condition. Lactation Risk Category L3 (Moderately Safe).
Infant Risk:
Low to moderate risk. Monitor infant for drowsiness, poor feeding, or developmental milestones.
Pediatric Use
Safety and efficacy have not been established for the treatment of generalized anxiety disorder in pediatric patients under 18 years of age. Studies in adolescents have not shown efficacy.
Geriatric Use
No specific dose adjustment is generally required based on age alone, but elderly patients may be more sensitive to the effects of buspirone. Start with lower doses and titrate slowly, monitoring closely for adverse effects such as dizziness or sedation.
Clinical Information
Clinical Pearls
- Buspirone is a non-sedating anxiolytic with no abuse potential, making it a good option for patients concerned about dependence or those with a history of substance abuse.
- Its slow onset of action (weeks for full effect) means it is not suitable for acute anxiety attacks or 'as-needed' use. Patients should be counseled on this to manage expectations.
- Unlike benzodiazepines, buspirone does not cause significant withdrawal symptoms upon discontinuation, but gradual tapering is still advisable to prevent return of anxiety symptoms.
- Avoid grapefruit juice due to significant CYP3A4 interaction, which can lead to increased buspirone levels and side effects.
- Consider buspirone for chronic generalized anxiety disorder (GAD), especially if patients have failed SSRIs/SNRIs or cannot tolerate them, or if benzodiazepines are contraindicated.
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
- Pregabalin
- Beta-blockers (e.g., propranolol) - for somatic symptoms of anxiety
- Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets (5mg generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 for more information. 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.