Buspirone hydrochloride 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.
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 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 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, lll1 as follows:
Generalized, persistent anxiety (of at least 1 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: 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 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 for 1 year without ill effect. Therefore, the physician who elects to use buspirone for extended periods should periodically reassess the usefulness of the drug for the individual patient.
Media Articles Related to Buspirone
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Category: Diseases and Conditions
Created: 1/31/2005 5:40:00 AM
Last Editorial Review: 6/5/2014 12:00:00 AM
Published Studies Related to Buspirone
Evaluation of buspirone for relapse-prevention in adults with cocaine dependence:
an efficacy trial conducted in the real world. 
Cocaine dependence is a significant public health problem for which there are
currently no FDA-approved medications.Unique aspects of the study include conducting an efficacy
trial in community treatment programs, a two-stage process to efficiently
evaluate buspirone, and an evaluation of mediators by which buspirone might exert
a beneficial effect on relapse prevention.
A pilot study of the efficacy and safety of paroxetine augmented with
risperidone, valproate, buspirone, trazodone, or thyroid hormone in adult Chinese
patients with treatment-resistant major depression. 
To compare the efficacy and safety of augmenting paroxetine with risperidone,
buspirone, valproate, trazodone, or thyroid hormone in patients with
treatment-resistant depression (TRD), 225 patients with retrospectively and/or
prospectively identified stage II TRD were randomly assigned to receive an 8-week
treatment of paroxetine 20 mg/d augmented with risperidone 2 mg/d (n = 45),
sodium valproate 600 mg/d (n = 39), buspirone 30 mg/d (n = 46), trazodone 100
mg/d (n = 47), or thyroid hormone 80 mg/d (n = 48)...
A double-blind, randomized, and placebo-controlled trial of buspirone added to risperidone in patients with chronic schizophrenia. [2010.12]
OBJECTIVE: The role of partial agonism at 5-HT1A receptors in general and of buspirone in particular remains unclear in the treatment of negative symptoms of schizophrenia. This study was designed to investigate the effect of buspirone added to risperidone as augmentation therapy in patients with chronic schizophrenia and prominent negative symptoms in a double-blind randomized clinical trial... CONCLUSIONS: The present study indicates buspirone as a potential adjunctive treatment strategy for the treatment of schizophrenia, in particular, negative symptoms. Nevertheless, results of larger controlled trials are needed before recommendation for a broad clinical application can be made. This trial is registered with the Iranian Clinical Trials Registry (IRCT138712051556N8).
Buspirone versus methylphenidate in the treatment of attention deficit hyperactivity disorder: a double-blind and randomized trial. [2010.12]
The efficacy and side effects of buspirone compared with methylphenidate (MPH) in the treatment of children with attention-deficit/hyperactivity disorder (ADHD). A total of 34 children with ADHD as defined by DSM-IV-TR were randomized to buspirone or methylphenidate dosed on weight-adjusted basis at buspirone (0.5 mg/kg/day) and methylphenidate (0.3-1 mg/kg/day) for a 6-week double-blind clinical trial...
Randomized, single-blind, trial of sertraline and buspirone for treatment of elderly patients with generalized anxiety disorder. [2010.04]
AIM: Generalized anxiety disorder (GAD) in elderly people is common, but few systematic studies regarding the best treatments have been performed. The aim of the present study was to evaluate the efficacy and safety of sertraline and buspirone in the treatment of elderly patients with GAD... CONCLUSION: Both sertraline and buspirone appear to be efficacious and well tolerated in the treatment of GAD in elderly patients. Further studies with larger sample size, evaluating the effect of medical illness, cognitive impairment, depression, and combined therapy with support and psychotherapy are needed.
Clinical Trials Related to Buspirone
Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting and Fed Conditions [Completed]
Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting Conditions [Completed]
Exploring Occupancy of Dopamine D3 Receptor by Buspirone in Humans Using PET [Recruiting]
The objective of the present study is to use positron emission tomography brain imaging to
investigate D3 occupancy of buspirone, an FDA-approved anxiolytic which acts as a serotonin
partial agonist but has recently been identified as a D3 antagonist. It is hypothesized
that clinically relevant doses of buspirone will occupy the D3 receptor.
Buspirone in the Treatment of 2-6 Year Old Children With Autistic Disorder [Recruiting]
The purpose of this study is to evaluate the effects of twice-daily oral buspirone on core
features of autism in autistic children aged 2-6 years as measured by the change from
baseline in the Autism Diagnostic Observation Schedule (ADOS) Composite Total scores
compared to placebo at 6 months.
Study of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence [Recruiting]
The purpose of this study is to evaluate whether or not buspirone is effective in preventing
relapse in cocaine-dependent adults in inpatient/residential treatment who are planning to
enter outpatient treatment upon inpatient/residential discharge.
Page last updated: 2014-07-22