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Before Using This Medicine
The safety of buspirone during pregnancy and lactation has not been established and, therefore, it should not be used in women of childbearing potential or nursing mothers, unless, in the opinion of t
he physician, the potential benefits to the patient outweigh the possible hazards to the fetus. Buspirone and its metabolites are excreted in milk in rats. The extent of excretion in human milk has no
t yet been determined.
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How should you take this medication?
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 maxim
um 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.
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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.
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Adverse Effects
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.
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Possible food and drug interactions when taking this medication
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 approach
ed with caution.
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What is this Drug
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.
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