Buspirone
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
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Overview
Buspirone is {{{aOrAn}}} Antianxiety that is FDA approved for the {{{indicationType}}} of anxiety disorders or the short-term relief of the symptoms of anxiety. Common adverse reactions include Nausea, Dizziness, Headache, Somnolence, Feeling nervous.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Anxiety Disorders
- Dosing information
- Recommended initial dose: 15 mg daily (7.5 mg b.i.d.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day, as needed. The maximum daily dosage should not exceed 60 mg per day. In clinical trials allowing dose titration, divided doses of 20 to 30 mg per day were commonly employed.
- The bioavailability of buspirone is increased when given with food as compared to the fasted state . Consequently, patients should take buspirone in a consistent manner with regard to the timing of dosing; either always with or always without food.
- When buspirone is to be given with a potent inhibitor of CYP3A4 the dosage recommendations described in the PRECAUTIONS, Drug Interactions section should be followed.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Buspirone in adult patients.
Non–Guideline-Supported Use
Depression
- Dosing information
- 5 mg administered 3 times daily for 4 weeks
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Buspirone FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Buspirone in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Buspirone in pediatric patients.
Contraindications
Buspirone Hydrochloride Tablets, USP are contraindicated in patients hypersensitive to buspirone hydrochloride.
Warnings
The administration of buspirone to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard. There have been reports of the occurrence of elevated blood pressure when buspirone hydrochloride has been added to a regimen including an MAOI. Therefore, it is recommended that buspirone not be used concomitantly with an MAOI. Because buspirone has no established antipsychotic activity, it should not be employed in lieu of appropriate antipsychotic treatment.
PRECAUTIONS
General
Interference With Cognitive and Motor Performance Studies indicate that buspirone is less sedating than other anxiolytics and that it does not produce significant functional impairment. However, its CNS effects in any individual patient may not be predictable. Therefore, patients should be cautioned about operating an automobile or using complex machinery until they are reasonably certain that buspirone treatment does not affect them adversely. While formal studies of the interaction of buspirone hydrochloride with alcohol indicate that buspirone does not increase alcohol-induced impairment in motor and mental performance, it is prudent to avoid concomitant use of alcohol and buspirone. Potential for Withdrawal Reactions in Sedative/Hypnotic/Anxiolytic Drug-Dependent Patients Because buspirone does not exhibit cross-tolerance with benzodiazepines and other common sedative/hypnotic drugs, it will not block the withdrawal syndrome often seen with cessation of therapy with these drugs. Therefore, before starting therapy with buspirone, it is advisable to withdraw patients gradually, especially patients who have been using a CNS-depressant drug chronically, from their prior treatment. Rebound or withdrawal symptoms may occur over varying time periods, depending in part on the type of drug, and its effective half-life of elimination. The syndrome of withdrawal from sedative/hypnotic/anxiolytic drugs can appear as any combination of irritability, anxiety, agitation, insomnia, tremor, abdominal cramps, muscle cramps, vomiting, sweating, flu-like symptoms without fever, and occasionally, even as seizures. Possible Concerns Related to Buspirone’s Binding to Dopamine Receptors Because buspirone can bind to central dopamine receptors, a question has been raised about its potential to cause acute and chronic changes in dopamine-mediated neurological function (e.g., dystonia, pseudo-parkinsonism, akathisia, and tardive dyskinesia). Clinical experience in controlled trials has failed to identify any significant neuroleptic-like activity; however, a syndrome of restlessness, appearing shortly after initiation of treatment, has been reported in some small fraction of buspirone-treated patients. The syndrome may be explained in several ways. For example, buspirone may increase central noradrenergic activity; alternatively, the effect may be attributable to dopaminergic effects (i.e., represent akathisia). See ADVERSE REACTIONS, Postmarketing Experience.
Adverse Reactions
Clinical Trials Experience
Commonly Observed
The more commonly observed untoward events associated with the use of buspirone not seen at an equivalent incidence among placebo-treated patients include dizziness, nausea, headache, nervousness, lightheadedness, and excitement.
Associated With Discontinuation of Treatment
One guide to the relative clinical importance of adverse events associated with buspirone is provided by the frequency with which they caused drug discontinuation during clinical testing. Approximately 10% of the 2200 anxious patients who participated in the buspirone premarketing clinical efficacy trials in anxiety disorders lasting 3 to 4 weeks discontinued treatment due to an adverse event. The more common events causing discontinuation included: central nervous system disturbances (3.4%), primarily dizziness, insomnia, nervousness, drowsiness, and lightheaded feeling; gastrointestinal disturbances (1.2%), primarily nausea; and miscellaneous disturbances (1.1%), primarily headache and fatigue. In addition, 3.4% of patients had multiple complaints, none of which could be characterized as primary.
Incidence in Controlled Clinical Trials
The table that follows enumerates adverse events that occurred at a frequency of 1% or more among buspirone hydrochloride patients who participated in 4 week, controlled trials comparing buspirone with placebo. The frequencies were obtained from pooled data for 17 trials. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. Comparison of the cited figures, however, does provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side-effect incidence rate in the population studied.
Other Events Observed During the Entire Premarketing Evaluation of Buspirone
During its premarketing assessment, buspirone was evaluated in over 3500 subjects. This section reports event frequencies for adverse events occurring in approximately 3000 subjects from this group who took multiple doses of buspirone in the dose range for which buspirone is being recommended (i.e., the modal daily dose of buspirone fell between 10 and 30 mg for 70% of the patients studied) and for whom safety data were systematically collected. The conditions and duration of exposure to buspirone varied greatly, involving well-controlled studies as well as experience in open and uncontrolled clinical settings. As part of the total experience gained in clinical studies, various adverse events were reported. In the absence of appropriate controls in some of the studies, a causal relationship to buspirone hydrochloride treatment cannot be determined. The list includes all undesirable events reasonably associated with the use of the drug. The following enumeration by organ system describes events in terms of their relative frequency of reporting in this data base. Events of major clinical importance are also described in the PRECAUTIONS section. The following definitions of frequency are used: Frequent adverse events are defined as those occurring in at least 1/100 patients. Infrequent adverse events are those occurring in 1/100 to 1/1000 patients, while rare events are those occurring in less than 1/1000 patients.
Cardiovascular
Frequent was nonspecific chest pain; infrequent were syncope, hypotension, and hypertension; rare were cerebrovascular accident, congestive heart failure, myocardial infarction, cardiomyopathy, and bradycardia.
Central Nervous System
Frequent were dream disturbances; infrequent were depersonalization, dysphoria, noise intolerance, euphoria, akathisia, fearfulness, loss of interest, dissociative reaction, hallucinations, involuntary movements, slowed reaction time, suicidal ideation, and seizures; rare were feelings of claustrophobia, cold intolerance, stupor, and slurred speech and psychosis.
EENT
Frequent were tinnitus, sore throat, and nasal congestion; infrequent were redness and itching of the eyes, altered taste, altered smell, and conjunctivitis; rare were inner ear abnormality, eye pain, photophobia, and pressure on eyes.
Endocrine
Rare were galactorrhea and thyroid abnormality.
Gastrointestinal
Infrequent were flatulence, anorexia, increased appetite, salivation, irritable colon, and rectal bleeding; rare was burning of the tongue.
Genitourinary
Infrequent were urinary frequency, urinary hesitancy, menstrual irregularity and spotting, and dysuria; rare were amenorrhea, pelvic inflammatory disease, enuresis, and nocturia.
Musculoskeletal
Infrequent were muscle cramps, muscle spasms, rigid/stiff muscles, and arthralgias; rare was muscle weakness.
Respiratory
Infrequent were hyperventilation, shortness of breath, and chest congestion; rare was epistaxis.
Sexual Function
Infrequent were decreased or increased libido; rare were delayed ejaculation and impotence.
Skin
Infrequent were edema, pruritus, flushing, easy bruising, hair loss, dry skin, facial edema, and blisters; rare were acne and thinning of nails.
Clinical Laboratory
Infrequent were increases in hepatic aminotransferases (SGOT, SGPT); rare were eosinophilia, leukopenia, and thrombocytopenia.
Miscellaneous
Infrequent were weight gain, fever, roaring sensation in the head, weight loss, and malaise; rare were alcohol abuse, bleeding disturbance, loss of voice, and hiccoughs.
Postmarketing Experience
Postmarketing experience has shown an adverse experience profile similar to that given above. Voluntary reports since introduction have included rare occurrences of allergic reactions (including urticaria), angioedema, cogwheel rigidity, dizziness (rarely reported as vertigo), dystonic reactions (including dystonia), ataxias, extrapyramidal symptoms, dyskinesias (acute and tardive), ecchymosis, emotional lability, serotonin syndrome, transient difficulty with recall, urinary retention, visual changes (including tunnel vision), parkinsonism, akathisia, restless leg syndrome, and restlessness. Because of the uncontrolled nature of these spontaneous reports, a causal relationship to buspirone treatment has not been determined.
Drug Interactions
There is limited information regarding Buspirone Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Buspirone in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Buspirone in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Buspirone during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Buspirone in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Buspirone in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Buspirone in geriatric settings.
Gender
There is no FDA guidance on the use of Buspirone with respect to specific gender populations.
Race
There is no FDA guidance on the use of Buspirone with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Buspirone in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Buspirone in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Buspirone in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Buspirone in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Buspirone Administration in the drug label.
Monitoring
There is limited information regarding Buspirone Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Buspirone and IV administrations.
Overdosage
There is limited information regarding Buspirone overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Buspirone Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Buspirone Mechanism of Action in the drug label.
Structure
There is limited information regarding Buspirone Structure in the drug label.
Pharmacodynamics
There is limited information regarding Buspirone Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Buspirone Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Buspirone Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Buspirone Clinical Studies in the drug label.
How Supplied
There is limited information regarding Buspirone How Supplied in the drug label.
Storage
There is limited information regarding Buspirone Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Buspirone Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Buspirone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Buspirone Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Buspirone Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.