Buspirone hydrochloride tablets USP are 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.
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 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 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 (300.02) is described in the American Psychiatric Associations Diagnostic and Statistical Manual, III 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 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.
Media Articles Related to Buspirone
Anxiety Doubles Cancer Mortality in Men, but Not Women
Source: Medscape Psychiatry & Mental Health Headlines [2016.09.21]
A diagnosis of generalized anxiety disorder is associated with a significant increase in cancer mortality risk in men but, oddly, not in women, new research shows.
Medscape Medical News
Anxiety - a risk factor for death from cancer in men
Source: Anxiety / Stress News From Medical News Today [2016.09.21]
Men who suffer from anxiety are more than twice as likely to die from cancer as men who don't.
Scientists discover response to anxiety linked to movement control areas in brain
Source: Anxiety / Stress News From Medical News Today [2016.09.19]
Researchers have discovered that the response to anxiety in teenagers may include not only the parts of the brain which deal with emotions (the limbic system), as has been long understood, but also...
Source: MedicineNet Suicide Specialty [2016.08.24]
Title: Separation Anxiety
Category: Diseases and Conditions
Created: 10/10/2002 12:00:00 AM
Last Editorial Review: 8/24/2016 12:00:00 AM
Post-transplant anxiety linked to complex instructions, caregiver empathy
Source: Anxiety / Stress News From Medical News Today [2016.08.19]
Some anxiety is perfectly normal for kidney transplant patients, but new research suggests that medical staff can help patients feel more at ease when they leave the hospital and that could...
Published Studies Related to Buspirone
A randomized trial of concurrent smoking-cessation and substance use disorder
treatment in stimulant-dependent smokers. 
CONCLUSIONS: These results suggest that providing smoking-cessation treatment to
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...
Clinical Trials Related to Buspirone
Exploring Occupancy of Dopamine D3 Receptor by Buspirone in Humans Using PET [Completed]
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.
Study of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence [Completed]
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.
Buspirone, Stress, and Attentional Bias to Marijuana Cues [Recruiting]
This project has two primary goals. The first goal is to further scientific understanding
about marijuana abuse by examining two recognized factors in marijuana use and relapse: (1)
stress/anxiety and (2) atypical reactivity to marijuana-related stimuli (e. g., attentional
bias). The second goal is to attenuate the influence of stress/anxiety and attentional bias
to marijuana stimuli via administration of buspirone.
Buspirone is uniquely suited to this project because it has effects on neurotransmitter
systems known to modulate both stress/anxiety and attentional bias.
Buspirone in the Treatment of 2-6 Year Old Children With Autistic Disorder [Active, not 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.
Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders [Withdrawn]
The main objective of this exploratory 8 week pilot study is to evaluate the safety and
efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism
spectrum disorders. The study results will be used to generate hypotheses for a larger
randomized controlled clinical trial with explicit hypotheses and sufficient statistical
Page last updated: 2016-09-21