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Buspar - Buspirone

Buspirone HCl is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs.

Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl) butyl)-8-azaspiro [4,5] decane-7,9- dione monohydrochloride. The empirical formula is C21H31N5O2·HCl.

BuSpar is supplied for oral administration in 5 mg and 10 mg, white, ovoid-rectangular, scored tablets. BuSpar tablets, 5 mg and 10 mg, contain the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

Buspirone HCl is indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

The efficacy of buspirone HCl has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone HCl relieved anxiety in the presence of these coexisting depressive symptoms. 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 Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows:

Generalized, persistent anxiety (of at least one month continual duration), manifested by symptoms from three of the four following categories:

1. Motor tension: Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle.
2. 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.
3. Apprehensive expectation: Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.
4. Vigilance and scanning: Hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge", irritability, impatience.

The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD.

The effectiveness of buspirone HCl 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 buspirone HCl for 1 year without ill effect. Therefore, the physician who elects to use buspirone HCl for extended periods should periodically reassess the usefulness of the drug for the individual patient.

Buspirone is used for the treatment of nervousness and anxiety. Optimum results are usually seen after three to four weeks of treatment. This medication may be taken with or without food. Inform your physican if you are pregnant or nursing. Buspirone may cause dizziness and drowsiness; use caution while driving or operating hazardous machinery. Do not take any other sedating drugs or drink alcohol while taking this medication. Do not take this medication with a monoamine oxidase inhibitor. Notify physician if you develop muscle spasms, uncontrolled twitching in the face and body, or uncontrolled tongue movements.