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Overdose
In clinical pharmacology trials, buspirone up to 400 mg/day was administered to healthy male volunteers. As this dose was approached, the following symptoms were observed in descending order of freque ncy: drowsiness, ataxia, nausea and vomiting, dizziness, clammy feeling, difficulty thinking, feeling high, rushing sensation, gastric distress, headache, itching, miosis, hypotension, tremor, incoord ination, insomnia and hallucinations. In a dose ranging study in acute psychotic patients, up to 2400 mg/day was administered. Dizziness, nausea and vomiting were the most common adverse effects. One patient developed extrapyramidal symptoms at 600 mg/day.

Description
Short-term symptomatic relief of excessive anxiety in patients with generalized anxiety disorder (psychoneurotic disorder).

Eight 3-way short-term, controlled clinical trials involving buspi rone, diazepam and placebo are considered central to the evaluation of buspirone as an anxiolytic agent. In 4 of the 8 clinical trials, buspirone demonstrated a significant difference from placebo. In the other 4 trials, there was no significant difference between buspirone and placebo, but a significantly greater improvement was observed in 2 of these trials with diazepam than with placebo. The a dverse effect profiles of buspirone and diazepam in these clinical trials were, however, different.

DRUG ABUSE AND DEPENDENCE :
Although preliminary animal and human investigations suggest that buspirone may be significantly devoid of potential for producing physical or psychological dependence, only extensive clinical experie nce with the drug will provide conclusive evidence. Meanwhile, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of b uspirone misuse and abuse.

What special precautions should I follow?
Possible Concerns Related to Buspirone's Binding to Dopamine Receptors:
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, pseudoparkinsonism, 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. The syndrome may be explained in several ways.

Drug Interactions
There is 1 report suggesting that the concomitant use of trazodone and buspirone may have caused 3- to 6-fold elevations in ALT (SGPT) in a few patients. In a similar study, attempting to replicate th is finding, no interactive effect on hepatic transaminases was identified.

Special Wanring
CNS:
Dizziness, headache, drowsiness, lightheadedness, insomnia, fatigue, nervousness, decreased concentration, excitement, depression, confusion, nightmares/vivid dreams, anger/hostility. Infrequ ently (<1%) depersonalization, noise intolerance, euphoria/feeling high, dissociative reaction, fear, loss of interest, dysphoria, hallucinations, seizures, suicidal thoughts. Rarely, slurred speech, claustrophobia, cold intolerance, stupor, psychosis.

Neurologic:
Paresthesia, weakness, incoordination, tremor, numbness. Infrequently, muscle cramps and spasms, rigid/stiff muscles, involu ntary movements, akathisia, slowed reaction time. Rarely, tingling of limbs, stiff neck, rigidity of jaw, ataxia.