Buspirone

Important Safety Information — Buspirone

What is it approved for?

Buspirone is FDA-approved for the management of anxiety disorders and the short-term relief of the symptoms of anxiety. Its effectiveness was shown in trials of outpatients whose diagnosis roughly corresponds to generalized anxiety disorder (GAD), including many with coexisting depressive symptoms. The label notes that anxiety or tension from the stress of everyday life usually does not require an anxiety medicine, and that effectiveness in long-term use (more than three to four weeks) has not been demonstrated in controlled trials, so a provider who continues it reassesses its usefulness periodically.

Do not use if

• Taking an MAOI antidepressant, or having stopped one within the past 14 days, because of the risk of serotonin syndrome and elevated blood pressure
• Being treated with linezolid or methylene blue given into a vein
• Known allergy to buspirone

Before starting, tell your provider if

• Liver or kidney problems (buspirone is not recommended with severe impairment)
• How much alcohol you drink, and any use of benzodiazepines, sleep medicines or other sedatives, which should be withdrawn gradually before starting
• Antipsychotics or other medicines that act on the brain, SSRIs, SNRIs, triptans, tryptophan or trazodone
• Diltiazem, verapamil, erythromycin, itraconazole, ketoconazole, ritonavir, nefazodone, rifampin, dexamethasone, phenytoin, phenobarbital, carbamazepine or haloperidol, and how much grapefruit juice you drink
• A history of movement disorders such as Parkinsonism, dystonia or tardive dyskinesia
• Pregnancy, plans to become pregnant, or breastfeeding

Serious side effects — get medical help right away

• Serotonin syndrome. A potentially life-threatening reaction, reported with buspirone alone and more likely with other serotonin-affecting medicines, MAOIs or antipsychotics. Get help right away for agitation, hallucinations, confusion, a fast heartbeat, high or low blood pressure, sweating or fever, tremor, muscle stiffness or twitching, loss of coordination, seizures, nausea, vomiting or diarrhea.
• Elevated blood pressure with MAOIs. Raised blood pressure has been reported when buspirone was added to an MAOI, which is why the combination is contraindicated.
• Restlessness and movement-related reactions. A syndrome of restlessness shortly after starting has been reported in a small fraction of patients. Rare reports after marketing include dystonia, cogwheel rigidity, Parkinsonism, akathisia, restless legs and dyskinesias, although a causal link has not been established. Tell your provider about any unusual movements.
• Allergic reactions. Rare reports include hives and angioedema. Get emergency help for swelling of the face, lips, tongue or throat or trouble breathing.
• Impaired alertness. Buspirone's effects on alertness are not predictable in any one person. Do not drive or use machinery until you know how it affects you, and avoid alcohol.

Common side effects

Common side effects: dizziness, nausea, headache, nervousness, lightheadedness and excitement; drowsiness, trouble sleeping, dry mouth and fatigue were also reported in trials. These are not all the possible side effects.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Pregnancy and breastfeeding

Animal studies did not show harm to the fetus, but there are no adequate, well-controlled studies in pregnant women, so the label says buspirone should be used during pregnancy only if clearly needed. It is not known how much passes into human milk (it does in rats), and the label advises avoiding use while nursing if clinically possible. Tell your provider if you are pregnant, planning a pregnancy or breastfeeding.

If you are in crisis or thinking about suicide, call or text 988 (Suicide & Crisis Lifeline) or call 911.

Forever Health Rx does not provide crisis or emergency care.

Buspirone will not prevent withdrawal symptoms from benzodiazepines or other sedatives; do not stop those medicines on your own.

Buspirone has no established antipsychotic activity and is not a substitute for antipsychotic treatment.

Prescription only. Buspirone is available only after an online visit with a licensed provider, who determines whether treatment is appropriate for you. This summary does not replace the full prescribing information. Not medical advice. Results may vary.