Buspirone Hydrochloride is indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. It is an agent that is not chemically or pharmacologically related to the benzodiazepines (e.g. Valium, Xanax) barbituates, or other sedative/anti-anxiety drugs.

Buspirone tablets come in 5mg, 10mg, 15mg and 30mg strengths.

HOW DOES BUSPIRONE WORK?

The mechanism of action of BUSPAR is not clearly known. BUSPAR differs from typical benzodiazepines like Vallium or Xanax anti-anxiety medication in that it does not exert anti-seizure or muscle relaxant effects. It also lacks the prominent sedative effect that is associated with benzodiazepines

In vitro studies have shown that BUSPAR has a high affinity for serotonin receptors (receptors in the brain that mediate arousal). BUSPAR has no significant affinity for benzodiazepine receptors in the brain.

HOW EFFECTIVE IS BUSPAR?

The excellent efficacy of BUSPAR has been demonstrated in controlled clinical trials of outpatients with a diagnosis of Generalized Anxiety Disorder (GAD).

The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized, persistent anxiety (of at least one month continual duration), manifested by symptoms from three of the four following categories:

Motor tension: Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle.

Autonomic hyperactivity: Sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate.

Apprehensive expectation: Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.

Vigilance and scanning: Hyper-attentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge", irritability, impatience.

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.

DOSAGE AND ADMINISTRATION:

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.

ADVERSE REACTIONS

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.

DRUG ABUSE AND DEPENDENCE:

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.

BE SURE TO INCLUDE IN YOUR PHYSCIAL EXAMINATION/MEDICAL QUESTIONAIRRE FORM THE FOLLOWING INFORMATION: