In the U.S.—

In Canada—

• Antianxiety agent

Buspirone (byoo-SPYE-rone) is used to treat certain anxiety disorders or to relieve the symptoms of anxiety. However, buspirone usually is not used for anxiety or tension caused by the stress of everyday life.

It is not known exactly how buspirone works to relieve the symptoms of anxiety. Buspirone is thought to work by decreasing the amount and actions of a chemical known as serotonin in certain parts of the brain.

Buspirone is available only with your doctor's prescription, in the following dosage form:

Oral
• Tablets (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For buspirone, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to buspirone. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Buspirone has not been studied in pregnant women. However, buspirone has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding—It is not known whether buspirone passes into the breast milk of humans.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of buspirone in children up to 18 years of age with use in other age groups.

Older adults—This medicine has been tested in a limited number of older adults and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking buspirone, it is especially important that your health care professional know if you are taking any of the following:

• Erythromycin (e.g., ERYC, E.E.S.) or
• Itraconazole (e.g., Sporanox)—Higher blood levels of buspirone may occur, increasing the chance of side effects. Your doctor may change the dose of buspirone that you take

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline at doses more than 10 mg a day [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Taking buspirone while you are taking monoamine oxidase (MAO) inhibitors may cause high blood pressure

• Kidney disease or
• Liver disease—Buspirone may be removed from your body more slowly, which may increase the chance of side effects. Your doctor may need to adjust your dose

Take buspirone only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of unwanted effects.

After you begin taking buspirone, 1 to 2 weeks may pass before you begin to feel the effects of this medicine.

Dosing—

The dose of buspirone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of buspirone. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.

• For oral dosage forms (tablets):
  • Adults: To start, 5 milligrams (mg) two or three times a day, or 7.5 mg two times a day. Your doctor may increase your dose by 5 mg a day every few days if needed. However, the dose usually is not more than 60 mg a day.
  • Children up to 18 years of age: Use and dose must be determined by the doctor.
  • Older adults: To start, 5 milligrams (mg) two or three times a day, or 7.5 mg two times a day. Your doctor may increase your dose by 5 mg a day every few days if needed.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

If you will be using buspirone regularly for a long time, your doctor should check your progress at regular visits to make sure the medicine does not cause unwanted effects.

Buspirone may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

If you think you or someone else may have taken an overdose of buspirone, get emergency help at once. Some symptoms of an overdose are dizziness or lightheadedness; severe drowsiness or loss of consciousness; stomach upset, including nausea or vomiting; or very small pupils of the eyes.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Rare
  • Chest pain;  confusion;  fast or pounding heartbeat;  fever;  incoordination;  mental depression;  muscle weakness;  numbness, tingling, pain, or weakness in hands or feet;  skin rash or hives;  stiffness of arms or legs;  sore throat;  uncontrolled movements of the body 
  
  

• Symptoms of overdose--may be more severe than side effects seen at regular doses or several may occur together
  • Dizziness or lightheadedness;  drowsiness (severe) or loss of consciousness;  stomach upset, including nausea or vomiting;  very small pupils of the eyes 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Dizziness or lightheadedness, especially when getting up from a sitting or lying position;  headache;  nausea;  restlessness, nervousness, or unusual excitement 
  
  

• Less common or rare
  • Blurred vision;  clamminess or sweating ;  decreased concentration;  diarrhea;  drowsiness (more common with doses of more than 20 mg per day);  dryness of mouth;  muscle pain, spasms, cramps, or stiffness;  ringing in the ears;  trouble in sleeping, nightmares, or vivid dreams;  unusual tiredness or weakness 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.