Medically reviewed on Jan 13, 2019

Pronunciation

(byoo SPYE rone)

Index Terms

• BuSpar
• Buspirone Hydrochloride

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral, as hydrochloride:

Generic: 5 mg, 7.5 mg, 10 mg, 15 mg, 30 mg

Pharmacologic Category

• Antianxiety Agent, Miscellaneous

Pharmacology

The mechanism of action of buspirone is unknown. Buspirone has a high affinity for serotonin 5-HT_1A and 5-HT₂ receptors, without affecting benzodiazepine-GABA receptors. Buspirone has moderate affinity for dopamine D₂ receptors.

Absorption

Rapid and complete; bioavailability is limited by extensive first-pass effect; only ~1% of the oral dose reaches the systemic circulation unchanged

Distribution

V_d: 5.3 L/kg (Gammans 1986)

Metabolism

Hepatic oxidation, primarily via CYP3A4 to several metabolites including an active metabolite, 1-pyrimidinylpiperazine (1-PP; exhibits about 25% of the activity of buspirone); extensive first-pass effect

Excretion

Urine: 29% to 63% (primarily as metabolites); feces: 18% to 38%

Time to Peak

Serum: 40 to 90 minutes

Half-Life Elimination

2 to 3 hours; increased with renal or hepatic impairment

Protein Binding

~86%

Special Populations: Renal Function Impairment

AUC increased 4-fold.

Special Populations: Hepatic Function Impairment

AUC increased 13-fold.

Use: Labeled Indications

Generalized anxiety disorder: Management of generalized anxiety disorder or the short-term relief of the symptoms of anxiety

Off Label Uses

Unipolar depression, augmentation

Data from two randomized controlled trials in patients with nonpsychotic major depressive disorder without remission despite treatment with an SSRI (ie, citalopram and fluoxetine) support the use of buspirone as an augmentation strategy in the treatment of this condition. However, in comparison to bupropion, patients receiving buspirone had more adverse effects and less improvement in symptoms ^{[Appelberg 2001]}, ^{[Trivedi 2006]}. Additional trials may be necessary to further define the role of buspirone in this condition.

Based on the American Psychiatric Association (APA) practice guideline for the treatment of patients with major depressive disorder, buspirone (added to an SSRI) is an effective augmentation strategy for this condition.

Contraindications

Hypersensitivity to buspirone or any component of the formulation; concomitant use of MAOIs intended to treat depression or within 14 days of discontinuing MAOIs intended to treat depression; concomitant use of MAOIs within 14 days of discontinuing buspirone; initiation of buspirone in patients receiving reversible MAOIs (eg, linezolid, IV methylene blue).

Dosing: Adult

Note: Periodically assess the usefulness of the drug for the individual patient.

Generalized anxiety disorder: Oral: Initial: 10 to 15 mg/day in 2 to 3 divided doses; may increase every 2 to 3 days in increments of 5 mg/day to a maximum of 60 mg/day; usual dose: 20 to 30 mg/day in 2 to 3 divided doses (Chessick 2006; Sramek 1999).

Unipolar depression, augmentation (alternative agent following antidepressant switch and other augmentation agents) (off-label use): Oral: Initial: 15 to 20 mg/day in 2 divided doses; may increase every 3 to 7 days in increments of 10 to 15 mg/day to a maximum of 60 mg/day in 2 divided doses (APA 2010; Appelberg 2001; Trivedi 2006).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Anxiety disorders: Children and Adolescents: Oral: Limited information is available; dose is not well established. One pilot study of 15 children, 6-14 years of age (mean 10 years), with mixed anxiety disorders, used initial doses of 5 mg daily; doses were individualized with increases in increments of 5 mg/day every week as needed to a maximum dose of 20 mg/day divided into 2 doses; the mean dose required: 18.6 mg/day (Simeon, 1994). Some authors (Carrey, 1996 and Kutcher, 1992), based on their clinical experience, recommend higher doses (eg, 15-30 mg/day in 2 divided doses). An open-label study in 25 prepubertal inpatients (mean age: 8 ± 1.8 years; range: 5-11 years) with anxiety symptoms and moderately aggressive behavior used initial doses of 5 mg daily; doses were titrated upwards (over 3 weeks) by 5-10 mg every 3 days to a maximum dose of 50 mg/day; doses >5 mg/day were administered in 2 divided doses/day; buspirone was discontinued in 25% of the children due to increased aggression and agitation or euphoric mania; mean optimal dose (n=19): 28 mg/day; range: 10-50 mg/day; median: 30 mg/day (Pfeffer, 1997). Two placebo-controlled 6-week trials in children and adolescents (n=559; age: 6-17 years) with generalized anxiety disorder studied doses of 7.5-30 mg twice daily (15-60 mg/day); no significant differences between buspirone and placebo with respect to generalized anxiety disorder symptoms were observed (see package insert).

Administration

Oral: Administer with or without food, but must be consistent.

Dietary Considerations

Avoid large quantities of grapefruit juice.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light.

Drug Interactions

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy

Alizapride: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Antiemetics (5HT3 Antagonists): May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Antipsychotic Agents: Serotonin Modulators may enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Aprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Consider therapy modification

Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Bromopride: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Avoid combination

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants. Consider therapy modification

Calcium Channel Blockers (Nondihydropyridine): May increase the serum concentration of BusPIRone. Exceptions: Bepridil. Monitor therapy

Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Ceritinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of ceritinib with a narrow therapeutic index CYP3A substrate (eg, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus) should be avoided when possible. Exceptions are discussed separately. Monitor therapy

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Consider therapy modification

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of BusPIRone. Management: Consider alternatives to this combination. If coadministration of these agents is deemed necessary, monitor patients for reduced buspirone effects and increase buspirone doses as needed. Consider therapy modification

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of BusPIRone. Management: Limit the buspirone dose to 2.5 mg daily and monitor patients for increased buspirone effects/toxicities if combined with strong CYP3A4 inhibitors. Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Dapoxetine: May enhance the adverse/toxic effect of Serotonin Modulators. Avoid combination

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Monitor therapy

Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Consider therapy modification

Duvelisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Consider therapy modification

Erythromycin (Systemic): May increase the serum concentration of BusPIRone. Management: Limit the buspirone dose to 2.5 mg twice daily and monitor for increased buspirone effects/toxicities if combined with erythromycin. Consider therapy modification

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Consider therapy modification

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fosnetupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Grapefruit Juice: May increase the serum concentration of BusPIRone. Management: Monitor for increased effect of buspirone if combined with grapefruit juice. Patients should avoid consuming large quantities of grapefruit juice. Consider therapy modification

HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Ioflupane I 123: BusPIRone may diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

Larotrectinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Monitor therapy

Lorlatinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences. Consider therapy modification

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Metaxalone: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Consider therapy modification

Methylene Blue: BusPIRone may enhance the serotonergic effect of Methylene Blue. This could result in serotonin syndrome. Avoid combination

Methylphenidate: May enhance the adverse/toxic effect of Serotonin Modulators. Specifically, the risk of serotonin syndrome or serotonin toxicity may be increased. Monitor therapy

Metoclopramide: Serotonin Modulators may enhance the adverse/toxic effect of Metoclopramide. This may be manifest as symptoms consistent with serotonin syndrome or neuroleptic malignant syndrome. Monitor therapy

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Monitor therapy

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification

Minocycline: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Mirtazapine: CNS Depressants may enhance the CNS depressant effect of Mirtazapine. Monitor therapy

Mitotane: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification

Monoamine Oxidase Inhibitors: BusPIRone may enhance the adverse/toxic effect of Monoamine Oxidase Inhibitors. Specifically, blood pressure elevations been reported. Avoid combination

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Nefazodone: BusPIRone may enhance the serotonergic effect of Nefazodone. This could result in serotonin syndrome. Nefazodone may increase the serum concentration of BusPIRone. Management: Limit the buspirone dose to 2.5 mg daily and monitor patients for increased buspirone effects/toxicities if combined with nefazodone. Additionally, monitor patient for signs of serotonin toxicity/serotonin syndrome if these agents are combined. Consider therapy modification

Netupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Opioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Avoid combination

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Consider therapy modification

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Monitor therapy

Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when used with pitolisant. Consider therapy modification

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Monitor therapy

Resveratrol: May increase the serum concentration of BusPIRone. Monitor therapy

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Selective Serotonin Reuptake Inhibitors: BusPIRone may enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This may cause serotonin syndrome. Selective Serotonin Reuptake Inhibitors may decrease the metabolism of BusPIRone. Management: The combination of a selective serotonin reuptake inhibitor and buspirone should be undertaken with great caution. When combined treatment is clinically indicated, monitor closely for signs of serotonin toxicity/serotonin syndrome. Consider therapy modification

Serotonin Modulators: May enhance the adverse/toxic effect of other Serotonin Modulators. The development of serotonin syndrome may occur. Exceptions: Nicergoline; Tedizolid. Monitor therapy

Serotonin Reuptake Inhibitor/Antagonists: BusPIRone may enhance the serotonergic effect of Serotonin Reuptake Inhibitor/Antagonists. Management: The combination of a serotonin reuptake inhibitor,antagonist and buspirone should be undertaken with great caution. When combined treatment is clinically indicated, monitor closely for signs of serotonin toxicity/serotonin syndrome. Consider therapy modification

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Consider therapy modification

St John's Wort: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Consider therapy modification

Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Tetrahydrocannabinol and Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Yohimbine: May diminish the therapeutic effect of Antianxiety Agents. Monitor therapy

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Consider therapy modification

Test Interactions

The presence of buspirone may result in a false positive on a urinary assay for metanephrine/catecholamine; discontinue buspirone ≥48 hours prior to collection of urine sample for catecholamines.

Adverse Reactions

>10%: Central nervous system: Dizziness (3% to 12%)

1% to 10%:

Cardiovascular: Chest pain (≥1%)

Central nervous system: Drowsiness (10%), headache (6%), nervousness (5%), confusion (2%), excitement (2%), numbness (2%), outbursts of anger (2%), abnormal dreams (≥1%), ataxia (1%) paresthesia (1%)

Dermatologic: Diaphoresis (1%), skin rash (1%)

Gastrointestinal: Nausea (8%), diarrhea (2%), sore throat (≥1%)

Neuromuscular & skeletal: Weakness (2%), musculoskeletal pain (1%), tremor (1%)

Ophthalmic: Blurred vision (2%)

Otic: Tinnitus (≥1%)

Respiratory: Nasal congestion (≥1%)

<1%, postmarketing, and/or case reports: Acne vulgaris, akathisia, alcohol abuse, alopecia, altered sense of smell, amenorrhea, angioedema, anorexia, apathy, arthralgia, bradycardia, bruise, cardiac failure, cardiomyopathy, cerebrovascular accident, change in libido, claustrophobia, cogwheel rigidity, cold intolerance, conjunctivitis, delayed ejaculation, depersonalization, dissociative reaction, dysgeusia, dyskinesia, dysphoria, dyspnea, dystonia, dysuria, edema, emotional lability, eosinophilia, epistaxis, euphoria, extrapyramidal reaction, eye pain, facial edema, fear, fever, flatulence, flushing, galactorrhea, glossopyrosis, hallucination, hemorrhagic diathesis, hiccups, hyperacusis, hypersensitivity reaction, hypertension, hyperventilation, hypotension, impotence, increased appetite, increased intraocular pressure, increased serum ALT, increased serum AST, increased serum transaminases, inner ear disturbance, involuntary muscle movements, irritable bowel syndrome, laryngitis, leukopenia, malaise, memory impairment, menstrual disease, muscle cramps, muscle spasm, myocardial infarction, nocturia, parkinsonian-like syndrome, pelvic inflammatory disease, personality disorder, photophobia, pruritus, psychosis, rectal hemorrhage, restless leg syndrome, restlessness, roaring sensation in head, salivation, seizure, serotonin syndrome, skin blister, slowed reaction time, slurred speech, stiffness, stupor, suicidal ideation, syncope, thinning of nails, thrombocytopenia, thyroid disease, urinary frequency, urinary hesitancy, urinary incontinence, urinary retention, urticaria, vertigo, visual disturbance (tunnel vision), weight gain, weight loss, xeroderma

Warnings/Precautions

Concerns related to adverse effects:

• Akathisia: Akathisia, or restlessness, has been reported in small number of patients; may be a result of central dopamine receptor antagonism. Monitor for signs of any dopamine-related movement disorders (eg, dystonia, akathisia, pseudo-parkinsonism, tardive dyskinesia).

• CNS depression: May rarely cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving).

• Serotonin syndrome: Potentially life-threatening serotonin syndrome has occurred with serotonergic agents, including buspirone, particularly when used in combination with other serotonergic agents (eg, triptans, TCAs, fentanyl, lithium, tramadol, buspirone, St John's wort, tryptophan) or agents that impair metabolism of serotonin (eg, MAOIs intended to treat psychiatric disorders, other MAOIs [ie, linezolid and IV methylene blue]). Monitor patients closely for signs of serotonin syndrome, such as mental status changes (eg, agitation, hallucinations, delirium, coma); autonomic instability (eg, tachycardia, labile blood pressure, diaphoresis, flushing, hyperthermia); neuromuscular changes (eg, tremor, rigidity, myoclonus); GI symptoms (eg, nausea, vomiting, diarrhea); and/or seizures. Discontinue treatment (and any concomitant serotonergic agent) immediately if signs/symptoms arise.

Disease-related concerns:

• Hepatic impairment: Use caution in patients with hepatic impairment; use in severe hepatic impairment is not recommended.

• Renal impairment: Use caution in patients with renal impairment; use in severe renal impairment is not recommended.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Sedative/hypnotic withdrawal: Buspirone does not exhibit cross-tolerance with benzodiazepines or other sedative/hypnotic agents. If substituting buspirone for any of these agents, gradually withdraw the drug(s) prior to initiating buspirone.

Monitoring Parameters

Mental status, symptoms of anxiety, signs/symptoms of serotonin syndrome.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience fatigue, dizziness, anxiety, headache, or nausea. Have patient report immediately to prescriber signs of serotonin syndrome (dizziness, severe headache, agitation, hallucinations, tachycardia, abnormal heartbeat, flushing, tremors, sweating a lot, change in balance, severe nausea, or severe diarrhea), agitation, abnormal movements, twitching, change in balance, difficulty speaking, or difficulty swallowing (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Further information

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