Buspar has been discontinued. Generic is available.

Indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD.

Because buspirone hydrochloride tablets have no established antipsychotic activity, it should not be employed in lieu of appropriate antipsychotic treatment.

The effects of BUSPAR have not been evaluated in patients with a history of convulsive disorders. Therefore, BUSPAR is not recommended for patients with a history of seizure disorders.

The syndrome of withdrawal from sedative/hypnotic/anxiolytic drugs can appear as any combination of irritability, anxiety, agitation, insomnia, tremor, abdominal cramps, muscle cramps, vomiting, sweating, flu-like symptoms without fever, and occasionally, even as seizures.

Because buspirone can bind to central dopamine receptors, a question has been raised about its potential to cause acute and chronic changes in dopamine-mediated neurological function (e.g., dystonia, pseudo-parkinsonism, akathisia, and tardive dyskinesia). Clinical experience in controlled trials has failed to identify any significant neuroleptic-like activity; however, a syndrome of restlessness, appearing shortly after initiation of treatment, has been reported in some small fraction of buspirone-treated patients.

While formal studies of the interaction of buspirone hydrochloride tablets with alcohol indicate that buspirone does not increase alcohol-induced impairment in motor and mental performance, it is prudent to avoid concomitant use of alcohol and buspirone.

The use of monoamine oxidase inhibitors (MAOIs) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure. The use of buspirone within 14 days of stopping an MAOI intended to treat depression is also contraindicated.

The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs, SSRIs, and other serotonergic drugs, including buspirone, alone but particularly with concomitant use of other serotonergic drugs (including triptans), with drugs that impair metabolism of serotonin (in particular, MAOIs, including reversible MAOIs such as linezolid and intravenous methylene blue), or with antipsychotics or other dopamine antagonists.

The concomitant use of buspirone with serotonin precursors (such as tryptophan) is not recommended.

If concomitant use of buspirone with a 5-hydroxytryptmine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.

Treatment with buspirone and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.

Patients receiving buspirone should be advised to avoid drinking such large amounts of grapefruit juice.

Concomitant administration of buspirone and haloperidol resulted in increased serum haloperidol concentrations.

Co-administration of buspirone with itraconazole increased plasma buspirone concentrations.

Co-administration of buspirone with nefazodone resulted in marked increases in plasma buspirone concentrations.

Co-administration of buspirone with rifampin decreased the plasma concentrations of buspirone.

There is one report suggesting that the concomitant use of Desyrel (trazodone hydrochloride) and buspirone may have caused 3- to 6-fold elevations on SGPT (ALT) in a few patients.

Adverse events attributable to buspirone may be more likely during concomitant administration with either diltiazem or verapamil.

In a study in healthy volunteers, co-administration of buspirone with erythromycin increased plasma buspirone concentrations (5-fold increase in C max and 6-fold increase in AUC).

Because the effects of concomitant administration of buspirone with most other psychotropic drugs have not been studied, the concomitant use of buspirone with other CNS-active drugs should be approached with caution.

Substances that inhibit CYP3A4, such as ketoconazole or ritonavir, may inhibit buspirone metabolism and increase plasma concentrations of buspirone while substances that induce CYP3A4, such as dexamethasone or certain anticonvulsants (phenytoin, phenobarbital, carbamazepine), may increase the rate of buspirone metabolism.

Co-administration of buspirone with cimetidine was found to increase C max (40%) and T max (2-fold), but had minimal effects on the AUC of buspirone.

Buspirone hydrochloride may interfere with the urinary metanephrine/catecholamine assay. It has been mistakenly read as metanephrine during routine assay testing for pheochromocytoma, resulting in a false positive laboratory result. Buspirone hydrochloride should therefore be discontinued for at least 48 hours prior to undergoing a urine collection for catecholamines.

Well-controlled studies during pregnancy have not been performed.

Buspirone hydrochloride tablets administration to nursing women should be avoided if clinically possible.

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• Dosage greater than 60 mg per day. GoToSource

• Use in patients under the age of 18. GoToSource

• Depression. GoToSource

• Attention-deficit/hyperactivity disorder. GoToSource

• Post-traumatic stress disorder. GoToSource

• Ineffective esophageal motility. GoToSource

• Bruxism. GoToSource

• Sexual dysfunction. GoToSource

• Smoking cessation. GoToSource

• Aggressive behavior and hyperactivity in children with autism. GoToSource

• Premenstrual syndrome. GoToSource

• Enhance cognitive function in patients with schizophrenia. GoToSource

• Postoperative nausea and vomiting. GoToSource

• Cognitive deficits associated with traumatic brain injury. GoToSource

• Cocaine withdrawal-induced anxiety. GoToSource

• Respiratory disorders associated with rett syndrome. GoToSource

• Tardive dyskinesia. GoToSource

• Functional dyspepsia. GoToSource

• Use with risperidone to augment therapy for patients with chronic schizophrenia. GoToSource

• Irritability in huntington’s disease. GoToSource 

• Suppression of shivering during hypothermia. GoToSource

• Olivopontocerebellar atrophy. GoToSource

• Apneusis. GoToSource

• Bulimia nervosa. GoToSource

• Acquired nystagmus. GoToSource

• Social phobia. GoToSource

• Obstructive sleep apnea hypopnea syndrome. GoToSource

• Panic disorder. GoToSource

• Body dysmorphic disorder. GoToSource

• Agitation of late-life psychosis and alzheimer’s disease. GoToSource

• Separation anxiety disorder. GoToSource

• Ataxia. GoToSource

• Kleptomania. GoToSource

• Prophylactic treatment of chronic tension-type headache. GoToSource

• Obsessional compulsive disorder. GoToSource

Serotonin syndrome (potentially life-threatening drug reaction). GoToSource

Acute dystonia (movement disorder). GoToSource

Alopecia (hair loss). GoToSource

Central nervous system disorders (including abnormal dreams, ataxia, confusion, dizziness, drowsiness, excitement, headache, nervousness, numbness, outbursts of anger, paresthesia), blurred vision, tinnitus (noise or ringing in ears), diaphoresis (excessive sweating), skin rash, CNS depression, anaphylaxis (potentially life-threatening allergic reaction) and akathisia (movement disorder). GoToSource

Tardive dyskinesia (uncontrolled or involuntary movements). GoToSource

No major injury lawsuits reported.