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buspirone hydrochloride tablets are 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 hydrochloride tablets have 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 hydrochloride tablets 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 3 2 is described in the american psychiatric association s diagnostic and statistical manual iii1 as follows generalized persistent anxiety of at least 1 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 hydrochloride tablets 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 hydrochloride tablets for 1 year without ill effect therefore the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient
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