Buspirone (Buspirone Hydrochloride) - Summary

BUSPIRONE SUMMARY

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:

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 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.

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NEWS HIGHLIGHTS

Media Articles Related to Buspirone

Easing Needle Anxiety
Source: Anxiety / Stress News From Medical News Today [2009.11.19]
Needle! For some people, the word-almost as much as the sight of one sliding into skin-is enough for people to cringe, cry, even swoon if they're standing in line waiting for one. Experts believe fear of needles may be preventing people from rolling up their sleeves for the H1N1 vaccination.

Depression As Deadly As Smoking, But Anxiety May Be Good For You
Source: Anxiety / Stress News From Medical News Today [2009.11.19]
A study by researchers at the University of Bergen, Norway, and the Institute of Psychiatry (IoP) at King's College London has found that depression is as much of a risk factor for mortality as smoking.

At-Risk College Students Reduce HBP, Anxiety, Depression Through Transcendental Meditation
Source: Anxiety / Stress News From Medical News Today [2009.11.18]
The Transcendental Meditation technique may be an effective method to reduce blood pressure, anxiety, depression, and anger among at-risk college students, according to a new study to be published in the American Journal of Hypertension, December 2009.

Anxiety And Distress During Active Surveillance For Early Prostate Cancer
Source: Prostate / Prostate Cancer News From Medical News Today [2009.11.16]
UroToday.com - The present study found that the majority of men with early prostate cancer (PC) included in a protocol-based program for active surveillance (AS) show favorable anxiety and distress scores when compared to reference values and to groups of patients with PC who underwent other treatments.

Doctors gird for patient anxiety over Zetia data (Reuters)
Source: Y! Health Anxiety News [2009.11.16]
Reuters - The good news for Merck & Co's Zetia cholesterol fighter is that doctors do not seem unduly concerned about its latest setback in a clinical trial. The bad news is they think patient anxiety will cause its sales to drop anyway.

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Published Studies Related to Buspirone

A placebo-controlled trial of buspirone for the treatment of marijuana dependence. [2009.11.01]
The present study investigated the potential efficacy of buspirone for treating marijuana dependence. Participants received either buspirone (maximum 60mg/day) (n=23) or matching placebo (n=27) for 12 weeks, each in conjunction with motivational interviewing.Further study with buspirone in this population may be warranted; however, strategies to enhance study retention and improve outcome measurement should be considered in future trials.

Comparison of ketanserin, buspirone and propranolol on arousal, pupil size and autonomic function in healthy volunteers. [2009.07]
RATIONALE: The human pupil may be a suitable physiological test system for the assessment of excessive daytime sleepiness (EDS), but pupillometric assessment could be confounded by medication for comorbid hypertension and mood disorders. OBJECTIVES: We examined the profile of the 5HT-2/alpha1/H1 antagonist ketanserin, the 5HT1a agonist buspirone and the beta adrenoceptor antagonist propranolol on pupillary and other measures of arousal... CONCLUSIONS: Ketanserin but not propranolol had a fully sedative profile and may confound pupillometric assessment of EDS. Beta adrenergic receptors do not appear to participate in arousal and pupillary functions, while 5HT1a receptors reduce pupil size without affecting arousal. Pupil size may not be used unequivocally as an index of the level of alertness in the case of drug-induced changes, when drugs interfere with the central pupil control mechanism in ways that are unrelated to their effects on arousal.

Effect of buspirone on thermal sensory and pain thresholds in human volunteers. [2009.05.29]
BACKGROUND: Buspirone is a partial 5-HT1A receptor agonist. Animal studies have shown that modulation of serotoninergic transmission at the 5-HT1A receptor can induce analgesia in acute pain models. However, no studies have been published so far on the effects of serotonin receptor agonists on pain perception in humans... CONCLUSION: Buspirone in the maximal recommended dose was without significant effect on thermal pain. However, as it is only a partial agonist at the 5-HT1A receptor and also acts on other receptor types, the negative results of the present study do not rule out a possible analgesic effect of more specific 5-HT1A receptor agonists.

The effect of oral buspirone, pyridostigmine, and bethanechol on esophageal function evaluated with combined multichannel esophageal impedance-manometry in healthy volunteers. [2009.03]
BACKGROUND: There is limited information on medications with promotility effects on the esophagus. Studies in healthy volunteers have shown the potential role of the direct cholinergic agonist bethanechol and the serotonin receptor agonist buspirone in improving esophageal motility. It has been also shown that an acetylcholinesterase inhibitor, the short-acting drug edrophonium administered intravenously caused a greater increase in the esophageal contraction amplitude and duration than bethanechol. Edrophonium cannot be used as a promotility therapy owing to short duration of action and lack of oral administration. The use of another acetylcholinesterase inhibitor pyridostygmine with longer duration of action has not been studied. The aim of the study was to evaluate the effect of oral pyridostygmine (60 mg), buspirone (20 mg), and bethanechol (25 mg) on esophageal function assessed by combined multichannel intraluminal impedance-esophageal manometry... CONCLUSIONS: Oral pyridostygmine, buspirone, and bethanechol enhance esophageal motility with pyridostygmine appearing to have the greatest effect. A potential effect on improving esophageal function and symptoms in patients requires further study.

Influence of buspirone on gastric sensorimotor function in man. [2008.12.01]
BACKGROUND: Previous studies have suggested involvement of 5HT(1) receptors in the control of gastric tone. AIM: To study the effect of buspirone, a 5HT(1A) agonist, on gastric sensorimotor function in healthy volunteers... CONCLUSION: Buspirone dose-dependently relaxes the proximal stomach in the fasting state and decreases the gastric emptying rate in healthy volunteers.

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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]

Dexmed/Buspirone Synergism on Shivering [Completed]
The purpose of this research is to determine if the combination of buspirone and dexmedetomidine are effective as a treatment to induce therapeutic hypothermia.

The design of the study includes four study days done in random order. The days are as follows: 1) Control (no drug); 2) Buspirone 60 mg orally; 3) Dexmedetomidine (delivered by a computer-controlled IV infusion to a target plasma concentration of 0. 6 ng/ml); and, 3) the combination of buspirone 60 mg and dexmedetomidine (target plasma concentration of 0. 6 ng/ml). a 20 cm-long catheter will be inserted into a cubital vein using standard aseptic technique In addition to the PIC line catheter, a simple peripheral catheter will be inserted into the other arm for drug administration.

Throughout the study period, mean-skin temperature will be maintained at 31°C by adjusting the temperature of circulating water (Cincinnati Sub-Zero, Cincinnati, OH) and forced-air warmers (Augustine Medical, Inc., Eden Prairie, MN). Furthermore, the back, upper-body, and lower-body will individually be maintained at the designated skin temperature. Lactated Ringer's solution cooled to ≈3°C will be infused via the PIC-line at rates sufficient to decrease tympanic membrane temperature ≈1. 5°C/h. Fluid will be administered as long as oxygen consumption or electromyographic intensity (see below) continues to increase or a total of 5 liters of fluid is given. Heart rate will be measured continuously using an electrocardiogram; blood pressure will be determined oscillometrically at 5 min intervals at the ankle. In case heart rate and/or blood pressure changes unexpectedly (by more than 30% of the baseline), the study will stop and the volunteer will be re-warmed immediately.

Effects of Buspirone in Opiate Withdrawal [Completed]
Dependence on heroin is a major public health problem because of its association with criminality, law enforcement costs and healthcare costs. Managed withdrawal is a required first step for a long term drug-free treatment of heroin addicts. Methadone and clonidine have been the mainstay of treatment for the relief of heroin withdrawal symptoms but both have limitations. The purpose of this study was to evaluate the efficacy of buspirone in the alleviation of the withdrawal symptoms experienced by heroin addicts when they stop using heroin. Buspirone is a non opiate drug with no abuse potential, no sedating effects and no withdrawal symptoms.

Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar [Completed]
Determine if there is a difference in treatment response for adults with ADHD who are treated with Strattera versus those treated with a combination of Strattera and buspirone

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