The effectiveness of BUSPAR 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. However, in a study of long-term use, 264 patients were treated with BUSPAR for 1 year without ill effect. Therefore, the physician who elects to use BUSPAR for extended periods should periodically reassess the usefulness of the drug for the individual patient.

The recommended initial dose is 15 mg daily (5 mg 3 times a day). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day, as needed. The maximum daily dosage should not exceed 60 mg per day. In clinical trials allowing dose titration, divided doses of 20 to 30 mg per day were commonly employed.

The more commonly observed untoward events associated with the use of BUSPAR not seen at an equivalent incidence among placebo-treated patients include dizziness, nausea, headache, nervousness, lightheadedness, and excitement.

Other common adverse events included: central nervous system disturbances (3.4%), primarily dizziness, insomnia, nervousness, drowsiness, and lightheaded feeling; gastrointestinal disturbances (1.2%), primarily nausea; and miscellaneous disturbances (1.1%), primarily headache and fatigue.

Interference with cognitive and motor performance: Studies indicate that BUSPAR is less sedating than other anti-anxiety medications and that it does not produce significant functional impairment. However, its CNS effects in any individual patient may not be predictable.

Therefore, patients should be cautioned about operating an automobile or using complex machinery until they are reasonably certain that BUSPAR treatment does not affect them adversely.

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

In human and animal studies, BUSPAR has shown no potential for abuse or diversion and there is no evidence that it causes tolerance, or either physical or psychological dependence. Human volunteers with a history of recreational drug or alcohol usage were studied in two double-blind clinical investigations. None of the subjects were able to distinguish between BUSPAR and placebo. In addition, studies in monkeys, mice, and rats have indicated that BUSPAR lacks potential for abuse.

Although there is no direct evidence that BUSPAR causes physical dependence or drug-seeking behavior, it is difficult to predict from experiments the extent to which a CNS-active drug will be misused.

Include any medications, prescription or non-prescription, alcohol, or drugs that you are now taking or plan to take during your treatment with BUSPAR.

Note if you are pregnant, or if you are planning to become pregnant while you are taking BUSPAR.

Note if you are breast-feeding an infant.