Buspirone hydrochloride
Generic name: buspirone hydrochloride · Brand names: BuSpar
Quick facts
Drug class
Section
DESCRIPTION
Source text (exact source wording)
Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs.
Medlineplus source text (exact source wording)
Buspirone is in a class of medications called anxiolytics.
Rx or otc
Rx (label title: 'Rx only'; DailyMed 'Product Type HUMAN PRESCRIPTION DRUG')
Controlled schedule
Section
DRUG ABUSE AND DEPENDENCE - Controlled Substance Class
Source text (exact source wording)
Buspirone hydrochloride is not a controlled substance.
Forms and strengths
- Buspirone hydrochloride is supplied as tablets for oral administration contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively).
- 5 mg: white to slightly off-white, oval, uncoated tablets, debossed with “349” on one side and a score on the other side.
- 7.5 mg: white to slightly off-white, oval, uncoated tablets, debossed with “350” on one side and a score on the other side.
- 10 mg: white to slightly off-white, oval, uncoated tablets, debossed with “351” on one side and a score on the other side.
- 15 mg: white to slightly off-white, rectangular, uncoated tablets, debossed with “3” and “52” with a score in between on one side and two scores on the other side.
- 30 mg: white to slightly off-white, rectangular, uncoated tablets, debossed with “3” and “53” with a score in between on one side and two scores on the other side.
Forms note
Standard tablets only (the Bucapsol capsule is a separate product). Imprints are those of the AiPing label and differ for other makers.
Generic available
Value
yes
Source
DailyMed Marketing Information of the chosen label: 'ANDA ANDA202087'; many ANDA buspirone tablet labels on DailyMed
Common use one line
Used for the management of anxiety disorders or the short-term relief of the symptoms of anxiety (label, Indications and Usage).
What it is used for
Buspirone treats anxiety disorders and gives short-term relief of anxiety symptoms. Anxiety or tension from the stress of everyday life usually does not need treatment with an anxiolytic. Its effect in long-term use, for more than 3 to 4 weeks, has not been shown in controlled trials, so a doctor who uses it for longer should periodically reassess whether it still helps.
Section
INDICATIONS AND USAGE
Source text (exact source wording)
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 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.
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 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.
Medlineplus source text (exact source wording)
Buspirone is used to treat anxiety. Buspirone is in a class of medications called anxiolytics. It works by changing the amounts of certain natural substances in the brain.
How it works
The label says the way buspirone works is unknown. In lab studies it has a high affinity for serotonin (5-HT1A) receptors and a moderate affinity for brain D2-dopamine receptors. Unlike benzodiazepines, it does not have anticonvulsant or muscle relaxant effects and lacks their prominent sedative effect.
Section
CLINICAL PHARMACOLOGY
Source text (exact source wording)
The mechanism of action of buspirone is unknown. Buspirone differs from typical benzodiazepine anxiolytics in that it does not exert anticonvulsant or muscle relaxant effects. It also lacks the prominent sedative effect that is associated with more typical anxiolytics. In vitro preclinical studies have shown that buspirone has a high affinity for serotonin (5-HT1A) receptors. Buspirone has no significant affinity for benzodiazepine receptors and does not affect GABA binding in vitro or in vivo when tested in preclinical models.
Buspirone has moderate affinity for brain D2-dopamine receptors. Some studies do suggest that buspirone may have indirect effects on other neurotransmitter systems.
Buspirone has moderate affinity for brain D2-dopamine receptors. Some studies do suggest that buspirone may have indirect effects on other neurotransmitter systems.
Dosage: adults
The recommended initial dose is 15 mg daily (7.5 mg b.i.d.). The dose may be increased 5 mg per day at intervals of 2 to 3 days, as needed. The maximum daily dosage should not exceed 60 mg per day. Divided doses of 20 mg to 30 mg per day were commonly used in clinical trials. Take it the same way each time, either always with or always without food. At least 14 days should pass between stopping an MAOI for depression and starting buspirone, and at least 14 days after stopping buspirone before starting an MAOI antidepressant.
Section
DOSAGE AND ADMINISTRATION
Source text (exact source wording)
The recommended initial dose is 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 mg to 30 mg per day were commonly employed.
The bioavailability of buspirone is increased when given with food as compared to the fasted state (see CLINICAL PHARMACOLOGY). 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.
At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with buspirone hydrochloride tablets. Conversely, at least 14 days should be allowed after stopping buspirone hydrochloride tablets before starting an MAOI antidepressant (see CONTRAINDICATIONS and DRUG INTERACTIONS).
The bioavailability of buspirone is increased when given with food as compared to the fasted state (see CLINICAL PHARMACOLOGY). 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.
At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with buspirone hydrochloride tablets. Conversely, at least 14 days should be allowed after stopping buspirone hydrochloride tablets before starting an MAOI antidepressant (see CONTRAINDICATIONS and DRUG INTERACTIONS).
Dosage: children
The label gives no pediatric dose. In two 6-week placebo-controlled trials of 559 patients aged 6 to 17 years with GAD, there were no significant differences between buspirone and placebo on GAD symptoms. There are no long-term safety or efficacy data in this population.
Section
Pediatric Use (PRECAUTIONS)
Source text (exact source wording)
The safety and effectiveness of buspirone were evaluated in two placebo-controlled 6-week trials involving a total of 559 pediatric patients (ranging from 6 to 17 years of age) with GAD. Doses studied were 7.5 mg to 30 mg b.i.d. (15 to 60 mg/day). There were no significant differences between buspirone and placebo with regard to the symptoms of GAD following doses recommended for the treatment of GAD in adults. Pharmacokinetic studies have shown that, for identical doses, plasma exposure to buspirone and its active metabolite, 1-PP, are equal to or higher in pediatric patients than adults. No unexpected safety findings were associated with buspirone in these trials. There are no long-term safety or efficacy data in this population.
Dosage adjustments
Drug interaction caps
With erythromycin, a low dose of buspirone (e.g., 2.5 mg b.i.d.) is recommended. With itraconazole or nefazodone, a low dose (e.g., 2.5 mg q.d.) is recommended. With rifampin the buspirone dose may need adjusting. With a potent CYP3A4 inhibitor a low dose used cautiously is recommended, and with a potent inducer the dose may need adjusting.
Section
PRECAUTIONS: Drug Interactions (CYP3A4)
Source text (exact source wording)
Erythromycin: ... If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg b.i.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.
Itraconazole: ... If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg q.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.
Nefazodone: ... If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg q.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.
Rifampin: ... If the two drugs are to be used in combination, the dosage of buspirone may need adjusting to maintain anxiolytic effect.
Consequently, when administered with a potent inhibitor of CYP3A4, a low dose of buspirone used cautiously is recommended. When used in combination with a potent inducer of CYP3A4 the dosage of buspirone may need adjusting to maintain anxiolytic effect.
Itraconazole: ... If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg q.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.
Nefazodone: ... If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg q.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.
Rifampin: ... If the two drugs are to be used in combination, the dosage of buspirone may need adjusting to maintain anxiolytic effect.
Consequently, when administered with a potent inhibitor of CYP3A4, a low dose of buspirone used cautiously is recommended. When used in combination with a potent inducer of CYP3A4 the dosage of buspirone may need adjusting to maintain anxiolytic effect.
Kidney
In patients with impaired kidney function, buspirone levels were higher and its half-life longer. After multiple doses in patients with Clcr = 10 to 70 mL/min/1.73 m2, steady-state AUC rose 4-fold. Use in patients with severe kidney impairment cannot be recommended.
Section
Use in Patients With Impaired Hepatic or Renal Function; CLINICAL PHARMACOLOGY - Renal Impairment
Source text (exact source wording)
Buspirone is metabolized by the liver and excreted by the kidneys. A pharmacokinetic study in patients with impaired hepatic or renal function demonstrated increased plasma levels and a lengthened half-life of buspirone. Therefore, the administration of buspirone hydrochloride tablets to patients with severe hepatic or renal impairment cannot be recommended (see CLINICAL PHARMACOLOGY).
After multiple-dose administration of buspirone to renally impaired (Clcr = 10 to 70 mL/min/1.73 m2) patients, steady-state AUC of buspirone increased 4-fold compared with healthy (Clcr ≥ 80 mL/min/1.73 m2) subjects (see PRECAUTIONS).
After multiple-dose administration of buspirone to renally impaired (Clcr = 10 to 70 mL/min/1.73 m2) patients, steady-state AUC of buspirone increased 4-fold compared with healthy (Clcr ≥ 80 mL/min/1.73 m2) subjects (see PRECAUTIONS).
Liver
In patients with liver impairment, steady-state AUC of buspirone increased 13-fold. Use in patients with severe liver impairment cannot be recommended.
Section
Use in Patients With Impaired Hepatic or Renal Function; CLINICAL PHARMACOLOGY - Hepatic Impairment
Source text (exact source wording)
Buspirone is metabolized by the liver and excreted by the kidneys. A pharmacokinetic study in patients with impaired hepatic or renal function demonstrated increased plasma levels and a lengthened half-life of buspirone. Therefore, the administration of buspirone hydrochloride tablets to patients with severe hepatic or renal impairment cannot be recommended (see CLINICAL PHARMACOLOGY).
After multiple-dose administration of buspirone to patients with hepatic impairment, steady-state AUC of buspirone increased 13-fold compared with healthy subjects (see PRECAUTIONS).
After multiple-dose administration of buspirone to patients with hepatic impairment, steady-state AUC of buspirone increased 13-fold compared with healthy subjects (see PRECAUTIONS).
Elderly
In one study, the 605 patients aged 65 or older had safety and efficacy similar to younger patients. Greater sensitivity of some older patients cannot be ruled out. Age had no effect on buspirone pharmacokinetics.
Section
Geriatric Use (PRECAUTIONS)
Source text (exact source wording)
In one study of 6632 patients who received buspirone for the treatment of anxiety, 605 patients were ≥65 years old and 41 were ≥75 years old; the safety and efficacy profiles for these 605 elderly patients (mean age = 70.8 years) were similar to those in the younger population (mean age = 43.3 years). Review of spontaneously reported adverse clinical events has not identified differences between elderly and younger patients, but greater sensitivity of some older patients cannot be ruled out.
There were no effects of age on the pharmacokinetics of buspirone (see CLINICAL PHARMACOLOGY: Special Populations).
There were no effects of age on the pharmacokinetics of buspirone (see CLINICAL PHARMACOLOGY: Special Populations).
Missed dose
MedlinePlus says to take a missed dose as soon as you remember. If it is almost time for the next dose, skip the missed one. Do not take a double dose.
Source text (exact source wording)
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Overdose
In trials, doses as high as 375 mg/day in healthy male volunteers caused nausea, vomiting, dizziness, drowsiness, miosis, and gastric distress. Complete recovery was the usual outcome in the few overdose cases reported. No specific antidote is known, and treatment is supportive. For an overdose, call poison control at 1-800-222-1222. If the person has collapsed, had a seizure, has trouble breathing, or can't be awakened, call 911.
Section
OVERDOSAGE (label); MedlinePlus 'In case of emergency/overdose'
Poison control
1-800-222-1222
Source text (exact source wording)
Signs and Symptoms
In clinical pharmacology trials, doses as high as 375 mg/day were administered to healthy male volunteers. As this dose was approached, the following symptoms were observed: nausea, vomiting, dizziness, drowsiness, miosis, and gastric distress. A few cases of overdosage have been reported, with complete recovery as the usual outcome. No deaths have been reported following overdosage with buspirone hydrochloride tablets alone. Rare cases of intentional overdosage with a fatal outcome were invariably associated with ingestion of multiple drugs and/or alcohol, and a causal relationship to buspirone could not be determined.
Recommended Overdose Treatment
General symptomatic and supportive measures should be used along with immediate gastric lavage. Respiration, pulse, and blood pressure should be monitored as in all cases of drug overdosage. No specific antidote is known to buspirone, and dialyzability of buspirone has not been determined.
In clinical pharmacology trials, doses as high as 375 mg/day were administered to healthy male volunteers. As this dose was approached, the following symptoms were observed: nausea, vomiting, dizziness, drowsiness, miosis, and gastric distress. A few cases of overdosage have been reported, with complete recovery as the usual outcome. No deaths have been reported following overdosage with buspirone hydrochloride tablets alone. Rare cases of intentional overdosage with a fatal outcome were invariably associated with ingestion of multiple drugs and/or alcohol, and a causal relationship to buspirone could not be determined.
Recommended Overdose Treatment
General symptomatic and supportive measures should be used along with immediate gastric lavage. Respiration, pulse, and blood pressure should be monitored as in all cases of drug overdosage. No specific antidote is known to buspirone, and dialyzability of buspirone has not been determined.
Medlineplus source text (exact source wording)
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include:
nausea, vomiting
dizziness
drowsiness
blurred vision
Symptoms of overdose may include:
nausea, vomiting
dizziness
drowsiness
blurred vision
Storage
Store at 20° to 25° C (68° to 77° F) in a tight, light-resistant container. MedlinePlus adds: keep it in the container it came in, tightly closed, out of reach of children, away from light, excess heat and moisture (not in the bathroom).
Section
HOW SUPPLIED
Labeler specific note
Wording is from the AiPing label; other labelers may differ.
Source text (exact source wording)
Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Medlineplus source text (exact source wording)
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from light, excess heat, and moisture (not in the bathroom).
Boxed warning
The label has no boxed warning.
Value
NONE
Note
No boxed warning appears in the chosen label.
Contraindications
Do not use buspirone if you are hypersensitive to it. Do not use it with an MAOI for depression, or within 14 days of stopping either one. Do not start buspirone in a patient being treated with a reversible MAOI such as linezolid or intravenous methylene blue, because of the risk of serotonin syndrome.
Section
CONTRAINDICATIONS
Source text (exact source wording)
Buspirone hydrochloride tablets are contraindicated in patients hypersensitive to buspirone hydrochloride.
The use of monoamine oxidase inhibitors (MAOIs) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure. The use of buspirone within 14 days of stopping an MAOI intended to treat depression is also contraindicated.
Starting buspirone in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS, DOSAGE AND ADMINISTRATION and DRUG INTERACTIONS).
The use of monoamine oxidase inhibitors (MAOIs) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure. The use of buspirone within 14 days of stopping an MAOI intended to treat depression is also contraindicated.
Starting buspirone in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS, DOSAGE AND ADMINISTRATION and DRUG INTERACTIONS).
Warnings and precautions
Using buspirone with an MAOI may pose a hazard. Elevated blood pressure has been reported when buspirone was added to a regimen including an MAOI, so the label recommends not using them together.
Heading
WARNINGS - MAOIs
Source text (exact source wording)
The administration of buspirone hydrochloride tablets 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 hydrochloride tablets not be used concomitantly with an MAOI.
A potentially life-threatening serotonin syndrome has been reported, particularly with other serotonergic drugs (including triptans), MAOIs, or antipsychotics. Symptoms may include agitation, hallucinations, delirium, coma, fast heartbeat, unstable blood pressure, dizziness, sweating, flushing, high body temperature, tremor, rigidity, muscle jerks, incoordination, seizures, nausea, vomiting and diarrhea. Patients should be monitored. If used with a triptan, careful observation is advised. Use with tryptophan is not recommended. Treatment is stopped immediately if these events occur.
Heading
WARNINGS - Serotonin Syndrome
Source text (exact source wording)
The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs, SSRIs, and other serotonergic drugs, including buspirone, alone but particularly with concomitant use of other serotonergic drugs (including triptans), with drugs that impair metabolism of serotonin (in particular, MAOIs, including reversible MAOIs such as linezolid and intravenous methylene blue), or with antipsychotics or other dopamine antagonists.
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for emergence of serotonin syndrome.
If concomitant use of buspirone with a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
The concomitant use of buspirone with serotonin precursors (such as tryptophan) is not recommended.
Treatment with buspirone and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for emergence of serotonin syndrome.
If concomitant use of buspirone with a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
The concomitant use of buspirone with serotonin precursors (such as tryptophan) is not recommended.
Treatment with buspirone and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.
Buspirone has no established antipsychotic activity, so it should not be used in place of appropriate antipsychotic treatment.
Heading
WARNINGS - No antipsychotic activity
Source text (exact source wording)
Because buspirone hydrochloride tablets have no established antipsychotic activity, it should not be employed in lieu of appropriate antipsychotic treatment.
Buspirone is less sedating than other anxiolytics, but its effects on the brain may not be predictable in any one person. Be careful driving or using complex machinery until you know how it affects you. The label says it is prudent to avoid alcohol with buspirone.
Heading
PRECAUTIONS - Interference with Cognitive and Motor Performance
Source text (exact source wording)
Studies indicate that buspirone hydrochloride tablets are 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.
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.
Buspirone will not block the withdrawal syndrome seen when benzodiazepines and similar drugs are stopped. Before starting, patients who have used a CNS-depressant drug chronically should be withdrawn gradually from it. Withdrawal can include irritability, anxiety, agitation, insomnia, tremor, abdominal cramps, muscle cramps, vomiting, sweating, flu-like symptoms without fever, and occasionally seizures.
Heading
PRECAUTIONS - Withdrawal reactions in sedative/hypnotic/anxiolytic drug-dependent patients
Source text (exact source wording)
Because buspirone hydrochloride tablets do 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 hydrochloride tablets, it is advisable to withdraw patients gradually, especially patients who have been using a CNS-depressant drug chronically, from their prior treatment.
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.
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.
Because buspirone binds to dopamine receptors, there is a question about movement problems such as dystonia, pseudo-parkinsonism, akathisia and tardive dyskinesia. Controlled trials found no significant neuroleptic-like activity, but a syndrome of restlessness shortly after starting has been reported in a small fraction of patients.
Heading
PRECAUTIONS - Dopamine receptor binding
Source text (exact source wording)
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.
Buspirone may cause a false positive on the urinary metanephrine/catecholamine test for pheochromocytoma. It should be stopped for at least 48 hours before a urine collection for catecholamines.
Heading
PRECAUTIONS - Drug/Laboratory Test Interactions
Source text (exact source wording)
Buspirone hydrochloride may interfere with the urinary metanephrine/catecholamine assay. It has been mistakenly read as metanephrine during routine assay testing for pheochromocytoma, resulting in a false positive laboratory result. Buspirone hydrochloride should therefore be discontinued for at least 48 hours prior to undergoing a urine collection for catecholamines.
Pregnancy and breastfeeding
No fetal damage was seen in rats and rabbits at doses of approximately 30 times the maximum recommended human dose, but adequate studies in pregnant women have not been done, so it should be used during pregnancy only if clearly needed. Whether buspirone passes into human milk is not known, but it does in rats, so the label says to avoid it in nursing women if clinically possible. MedlinePlus says to tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding, and to call if you become pregnant.
Section
PRECAUTIONS - Pregnancy: Teratogenic Effects; Labor and Delivery; Nursing Mothers
Source text (exact source wording)
Pregnancy Category B: No fertility impairment or fetal damage was observed in reproduction studies performed in rats and rabbits at buspirone doses of approximately 30 times the maximum recommended human dose. In humans, however, adequate and well-controlled studies during pregnancy have not been performed. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
The effect of buspirone hydrochloride tablets on labor and delivery in women is unknown. No adverse effects were noted in reproduction studies in rats.
Nursing Mothers: The extent of the excretion in human milk of buspirone or its metabolites is not known. In rats, however, buspirone and its metabolites are excreted in milk. Buspirone hydrochloride tablets administration to nursing women should be avoided if clinically possible.
The effect of buspirone hydrochloride tablets on labor and delivery in women is unknown. No adverse effects were noted in reproduction studies in rats.
Nursing Mothers: The extent of the excretion in human milk of buspirone or its metabolites is not known. In rats, however, buspirone and its metabolites are excreted in milk. Buspirone hydrochloride tablets administration to nursing women should be avoided if clinically possible.
Medlineplus source text (exact source wording)
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking buspirone, call your doctor.
Side effects
Common
The label lists these as the more commonly observed events not seen at an equivalent rate with placebo: dizziness, nausea, headache, nervousness, lightheadedness, and excitement.
Section
ADVERSE REACTIONS - Commonly Observed
Threshold
The label does not state a numeric threshold for this list. It names events 'not seen at an equivalent incidence among placebo-treated patients'.
Source text (exact source wording)
The more commonly observed untoward events associated with the use of buspirone hydrochloride tablets not seen at an equivalent incidence among placebo-treated patients include dizziness, nausea, headache, nervousness, lightheadedness, and excitement.
Less common
In 4-week placebo-controlled trials (buspirone n=477, placebo n=464), reactions in 1% or more included dizziness (12% vs 3%), drowsiness (10% vs 9%), nausea (8% vs 5%), headache (6% vs 3%), nervousness (5% vs 1%), fatigue (4% vs 4%), insomnia (3% vs 3%), lightheadedness (3% vs none listed), and dry mouth (3% vs 4%). Others at 2% or less included blurred vision, diarrhea, numbness, skin rash and weakness.
Section
ADVERSE REACTIONS - Incidence in Controlled Clinical Trials (table: TREATMENT-EMERGENT ADVERSE EXPERIENCE INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALS, percent of patients reporting)
Note
Table values are percent of patients, buspirone first then placebo. Reactions already named in 'common' also appear in this table with their percentages.
Source text (exact source wording)
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 hydrochloride tablets with placebo. The frequencies were obtained from pooled data for 17 trials.
Adverse Experience Buspirone (n=477) Placebo (n=464)
Cardiovascular
Tachycardia/Palpitations 1 1
CNS
Dizziness 12 3
Drowsiness 10 9
Nervousness 5 1
Insomnia 3 3
Lightheadedness 3 -
Decreased Concentration 2 2
Excitement 2 -
Anger/Hostility 2 -
Confusion 2 -
Depression 2 2
EENT
Blurred Vision 2 -
Gastrointestinal
Nausea 8 5
Dry Mouth 3 4
Abdominal/Gastric Distress 2 2
Diarrhea 2 -
Constipation 1 2
Vomiting 1 2
Musculoskeletal
Musculoskeletal Aches/Pains 1 -
Neurological
Numbness 2 -
Paresthesia 1 -
Incoordination 1 -
Tremor 1 -
Skin
Skin Rash 1 -
Miscellaneous
Headache 6 3
Fatigue 4 4
Weakness 2 -
Sweating/Clamminess 1 -
*Events reported by at least 1% of buspirone hydrochloride patients are included.
- Incidence less than 1%.
Adverse Experience Buspirone (n=477) Placebo (n=464)
Cardiovascular
Tachycardia/Palpitations 1 1
CNS
Dizziness 12 3
Drowsiness 10 9
Nervousness 5 1
Insomnia 3 3
Lightheadedness 3 -
Decreased Concentration 2 2
Excitement 2 -
Anger/Hostility 2 -
Confusion 2 -
Depression 2 2
EENT
Blurred Vision 2 -
Gastrointestinal
Nausea 8 5
Dry Mouth 3 4
Abdominal/Gastric Distress 2 2
Diarrhea 2 -
Constipation 1 2
Vomiting 1 2
Musculoskeletal
Musculoskeletal Aches/Pains 1 -
Neurological
Numbness 2 -
Paresthesia 1 -
Incoordination 1 -
Tremor 1 -
Skin
Skin Rash 1 -
Miscellaneous
Headache 6 3
Fatigue 4 4
Weakness 2 -
Sweating/Clamminess 1 -
*Events reported by at least 1% of buspirone hydrochloride patients are included.
- Incidence less than 1%.
Serious
The label warns of potentially life-threatening serotonin syndrome. Rare postmarketing reports include allergic reactions (including urticaria), angioedema, dystonic reactions, extrapyramidal symptoms, acute and tardive dyskinesias, parkinsonism, akathisia, restless leg syndrome and urinary retention; a causal relationship has not been determined. MedlinePlus says to call your doctor immediately for rash, hives, itching, or swelling of the face, eyes, mouth, throat, tongue, or lips; fast or irregular heartbeat; blurred vision; uncontrollable shaking; or signs such as agitation, fever, sweating, shivering, severe muscle stiffness, seizures, hallucinations or loss of coordination.
Label section
WARNINGS; ADVERSE REACTIONS - Postmarketing Experience
Label source text (exact source wording)
The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs, SSRIs, and other serotonergic drugs, including buspirone, alone but particularly with concomitant use of other serotonergic drugs (including triptans), with drugs that impair metabolism of serotonin (in particular, MAOIs, including reversible MAOIs such as linezolid and intravenous methylene blue), or with antipsychotics or other dopamine antagonists.
Postmarketing Experience: 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 hydrochloride tablets treatment has not been determined.
Postmarketing Experience: 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 hydrochloride tablets treatment has not been determined.
Medlineplus source text (exact source wording)
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
rash, hives, itching, or swelling of the face, eyes, mouth, throat, tongue, or lips
fast or irregular heartbeat
blurred vision
uncontrollable shaking of a part of the body
agitation, fever, sweating, dizziness, flushing, confusion, fast or irregular heartbeat, shivering, severe muscle stiffness or twitching, seizures, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
rash, hives, itching, or swelling of the face, eyes, mouth, throat, tongue, or lips
fast or irregular heartbeat
blurred vision
uncontrollable shaking of a part of the body
agitation, fever, sweating, dizziness, flushing, confusion, fast or irregular heartbeat, shivering, severe muscle stiffness or twitching, seizures, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
Source text (exact source wording)
see label_source_text and medlineplus_source_text
Led to discontinuation
About 10% of the 2200 anxious patients in 3 to 4 week premarketing trials stopped treatment because of an adverse event. The more common causes were central nervous system disturbances (3.4%), gastrointestinal disturbances (1.2%), and miscellaneous disturbances (1.1%). Another 3.4% had multiple complaints.
Section
ADVERSE REACTIONS - Associated with Discontinuation of Treatment
Source text (exact source wording)
Approximately 10% of the 2200 anxious patients who participated in the buspirone hydrochloride tablets 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.
Medwatch
To report SUSPECTED ADVERSE REACTIONS, contact AiPing Pharmaceutical, Inc. at 1-844-374-0016 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Medlineplus less serious source text (exact source wording)
Buspirone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
dizziness
nausea, diarrhea
headache
excitement
confusion
fatigue
nervousness
difficulty falling asleep or staying asleep
feelings of anger or hostility
lightheadedness
weakness
numbness
dizziness
nausea, diarrhea
headache
excitement
confusion
fatigue
nervousness
difficulty falling asleep or staying asleep
feelings of anger or hostility
lightheadedness
weakness
numbness
Interactions
Drugs
Contraindicated: MAOIs for depression with buspirone or within 14 days of stopping either one. Do not start buspirone in a patient being treated with linezolid or intravenous methylene blue.
Name
MAO inhibitors (including linezolid and intravenous methylene blue)
Section
PRECAUTIONS: Drug Interactions - Psychotropic Agents
Source text (exact source wording)
The use of monoamine oxidase inhibitors (MAOIs) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure. The use of buspirone within 14 days of stopping an MAOI intended to treat depression is also contraindicated.
Starting buspirone in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.
Starting buspirone in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.
With a triptan, careful observation is advised, especially at the start and with dose increases. Use with tryptophan is not recommended.
Name
Serotonergic drugs, triptans and tryptophan
Section
WARNINGS - Serotonin Syndrome
Source text (exact source wording)
If concomitant use of buspirone with a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
The concomitant use of buspirone with serotonin precursors (such as tryptophan) is not recommended.
The concomitant use of buspirone with serotonin precursors (such as tryptophan) is not recommended.
Verapamil and diltiazem raised buspirone levels in a study of nine healthy volunteers. Side effects may be more likely, and the buspirone dose may need adjusting based on clinical assessment.
Name
Diltiazem and verapamil
Section
PRECAUTIONS: Drug Interactions - CYP3A4
Source text (exact source wording)
In a study of nine healthy volunteers, co-administration of buspirone (10 mg as a single dose) with verapamil (80 mg t.i.d.) or diltiazem (60 mg t.i.d.) increased plasma buspirone concentrations (verapamil increased AUC and Cmax of buspirone 3.4-fold while diltiazem increased AUC and Cmax 5.5-fold and 4-fold, respectively.) Adverse events attributable to buspirone may be more likely during concomitant administration with either diltiazem or verapamil. Subsequent dose adjustment may be necessary and should be based on clinical assessment.
Erythromycin raised buspirone levels (5-fold in Cmax and 6-fold in AUC) and side effects. If used together, a low buspirone dose (e.g., 2.5 mg b.i.d.) is recommended.
Name
Erythromycin
Section
PRECAUTIONS: Drug Interactions - CYP3A4
Source text (exact source wording)
In a study in healthy volunteers, co-administration of buspirone (10 mg as a single dose) with erythromycin (1.5 g/day for 4 days) increased plasma buspirone concentrations (5-fold increase in Cmax and 6-fold increase in AUC). These pharmacokinetic interactions were accompanied by an increased incidence of side effects attributable to buspirone. If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg b.i.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.
Itraconazole raised buspirone levels (13-fold in Cmax and 19-fold in AUC) and side effects. If used together, a low buspirone dose (e.g., 2.5 mg q.d.) is recommended.
Name
Itraconazole
Section
PRECAUTIONS: Drug Interactions - CYP3A4
Source text (exact source wording)
In a study in healthy volunteers, co-administration of buspirone (10 mg as a single dose) with itraconazole (200 mg/day for 4 days) increased plasma buspirone concentrations (13-fold increase in Cmax and 19-fold increase in AUC). These pharmacokinetic interactions were accompanied by an increased incidence of side effects attributable to buspirone. If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg q.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.
Nefazodone markedly raised buspirone levels (up to 20-fold in Cmax and up to 50-fold in AUC). If used together, a low buspirone dose (e.g., 2.5 mg q.d.) is recommended.
Name
Nefazodone
Section
PRECAUTIONS: Drug Interactions - CYP3A4
Source text (exact source wording)
In a study of steady-state pharmacokinetics in healthy volunteers, co-administration of buspirone (2.5 or 5 mg b.i.d.) with nefazodone (250 mg b.i.d.) resulted in marked increases in plasma buspirone concentrations (increases up to 20-fold in Cmax and up to 50-fold in AUC). If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg q.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.
Rifampin lowered buspirone levels (83.7% decrease in Cmax; 89.6% decrease in AUC). The buspirone dose may need adjusting to keep its effect.
Name
Rifampin
Section
PRECAUTIONS: Drug Interactions - CYP3A4
Source text (exact source wording)
In a study in healthy volunteers, co-administration of buspirone (30 mg as a single dose) with rifampin (600 mg/day for 5 days) decreased the plasma concentrations (83.7% decrease in Cmax; 89.6% decrease in AUC) and pharmacodynamic effects of buspirone. If the two drugs are to be used in combination, the dosage of buspirone may need adjusting to maintain anxiolytic effect.
Ketoconazole or ritonavir may raise buspirone levels, and dexamethasone, phenytoin, phenobarbital or carbamazepine may speed its breakdown. A dose adjustment may be needed. With a potent CYP3A4 inhibitor a low dose used cautiously is recommended.
Name
Other CYP3A4 inhibitors and inducers (ketoconazole, ritonavir, dexamethasone, phenytoin, phenobarbital, carbamazepine)
Section
PRECAUTIONS: Drug Interactions - CYP3A4
Source text (exact source wording)
Substances that inhibit CYP3A4, such as ketoconazole or ritonavir, may inhibit buspirone metabolism and increase plasma concentrations of buspirone while substances that induce CYP3A4, such as dexamethasone or certain anticonvulsants (phenytoin, phenobarbital, carbamazepine), may increase the rate of buspirone metabolism. If a patient has been titrated to a stable dosage on buspirone, a dose adjustment of buspirone may be necessary to avoid adverse events attributable to buspirone or diminished anxiolytic activity. Consequently, when administered with a potent inhibitor of CYP3A4, a low dose of buspirone used cautiously is recommended. When used in combination with a potent inducer of CYP3A4 the dosage of buspirone may need adjusting to maintain anxiolytic effect.
Buspirone with haloperidol increased serum haloperidol levels in volunteers; the clinical significance is not clear.
Name
Haloperidol
Section
PRECAUTIONS: Drug Interactions - Psychotropic Agents
Source text (exact source wording)
In a study in normal volunteers, concomitant administration of buspirone and haloperidol resulted in increased serum haloperidol concentrations. The clinical significance of this finding is not clear.
One report suggested 3- to 6-fold ALT elevations in a few patients using trazodone and buspirone. A similar study did not find this effect.
Name
Trazodone
Section
PRECAUTIONS: Drug Interactions - Psychotropic Agents
Source text (exact source wording)
There is one report suggesting that the concomitant use of Desyrel® (trazodone hydrochloride) and buspirone may have caused 3- to 6-fold elevations on SGPT (ALT) in a few patients. In a similar study attempting to replicate this finding, no interactive effect on hepatic transaminases was identified.
Cimetidine increased buspirone Cmax (40%) and Tmax (2-fold) but had minimal effects on AUC.
Name
Cimetidine
Section
PRECAUTIONS: Drug Interactions - Other Drugs
Source text (exact source wording)
Co-administration of buspirone with cimetidine was found to increase Cmax (40%) and Tmax (2-fold), but had minimal effects on the AUC of buspirone.
There was one report of prolonged prothrombin time when buspirone was added to warfarin. In vitro, buspirone may displace digoxin; the clinical significance is unknown.
Name
Warfarin and digoxin
Section
PRECAUTIONS: Drug Interactions - Protein Binding
Source text (exact source wording)
However, there has been one report of prolonged prothrombin time when buspirone was added to the regimen of a patient treated with warfarin. The patient was also chronically receiving phenytoin, phenobarbital, digoxin, and Synthroid®. In vitro, buspirone may displace less firmly bound drugs like digoxin. The clinical significance of this property is unknown.
Effects with most other psychotropic drugs have not been studied, so use with other CNS-active drugs should be approached with caution.
Name
Other psychotropics
Section
PRECAUTIONS: Drug Interactions - Psychotropic Agents
Source text (exact source wording)
Because the effects of concomitant administration of buspirone with most other psychotropic drugs have not been studied, the concomitant use of buspirone with other CNS-active drugs should be approached with caution.
Food and alcohol
Large amounts of grapefruit juice raised buspirone levels (4.3-fold in Cmax; 9.2-fold in AUC). Avoid drinking large amounts of grapefruit juice. MedlinePlus also says to avoid large amounts of grapefruit.
Name
Grapefruit juice
Section
PRECAUTIONS: Drug Interactions; Information for Patients
Source text (exact source wording)
Grapefruit Juice: In a study in healthy volunteers, co-administration of buspirone (10 mg as a single dose) with grapefruit juice (200 mL double-strength t.i.d. for 2 days) increased plasma buspirone concentrations (4.3-fold increase in Cmax; 9.2-fold increase in AUC). Patients receiving buspirone should be advised to avoid drinking such large amounts of grapefruit juice.
During your treatment with buspirone hydrochloride tablets, avoid drinking large amounts of grapefruit juice.
During your treatment with buspirone hydrochloride tablets, avoid drinking large amounts of grapefruit juice.
Food increases how much buspirone is absorbed, so take it the same way each time, either always with or always without food.
Name
Food (consistency)
Section
DOSAGE AND ADMINISTRATION
Source text (exact source wording)
The bioavailability of buspirone is increased when given with food as compared to the fasted state (see CLINICAL PHARMACOLOGY). Consequently, patients should take buspirone in a consistent manner with regard to the timing of dosing; either always with or always without food.
The label says it is prudent to avoid alcohol with buspirone. MedlinePlus says alcohol can add to drowsiness and not to drink alcohol while taking buspirone.
Name
Alcohol
Section
PRECAUTIONS - General
Source text (exact source wording)
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.
Other
MedlinePlus lists cimetidine as a nonprescription product that may interact. Tell your doctor and pharmacist and do not start it without talking to your provider.
Name
Cimetidine (MedlinePlus nonprescription)
Section
MedlinePlus 'What special precautions should I follow?'
Source text (exact source wording)
the following nonprescription product may interact with buspirone: cimetidine. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking buspirone. Do not start this medication while taking buspirone without discussing with your healthcare provider.
The label names ritonavir as a possible CYP3A4 inhibitor that may raise buspirone levels. The Liverpool checkers were not checked.
Name
Antiviral interactions
Section
PRECAUTIONS: Drug Interactions
Source text (exact source wording)
The label lists ritonavir (a CYP3A4 inhibitor used in antiviral regimens) as a substance that may inhibit buspirone metabolism. Liverpool HIV/HEP interaction checkers: not checked in this run.
Patient tips
Do not take an MAOI, including the antibiotic linezolid, and do not take one within 2 weeks of stopping buspirone unless your physician directs it. Tell your physician about all medicines, alcohol, or drugs you take, and if you are pregnant, planning pregnancy, or breast-feeding. Do not drive or use dangerous machinery until you know how it affects you. Take it the same way each time with regard to food, and avoid large amounts of grapefruit juice. MedlinePlus adds: take it exactly as directed, it may take several weeks to reach a dose that works, and do not drink alcohol while taking it.
Label source
PRECAUTIONS - Information for Patients; PATIENT INSTRUCTION SHEET (tablet-splitting instructions only)
Label source text (exact source wording)
Do not take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
Do not take an MAOI within 2 weeks of stopping buspirone unless directed to do so by your physician.
Do not start buspirone if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
Inform your physician about any medications, prescription or non-prescription, alcohol, or drugs that you are now taking or plan to take during your treatment with buspirone hydrochloride tablets.
Inform your physician if you are pregnant, or if you are planning to become pregnant, or if you become pregnant while you are taking buspirone hydrochloride tablets.
Inform your physician if you are breast-feeding an infant.
Until you experience how this medication affects you, do not drive a car or operate potentially dangerous machinery.
You should take buspirone hydrochloride tablets consistently, either always with or always without food.
During your treatment with buspirone hydrochloride tablets, avoid drinking large amounts of grapefruit juice.
Do not take an MAOI within 2 weeks of stopping buspirone unless directed to do so by your physician.
Do not start buspirone if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
Inform your physician about any medications, prescription or non-prescription, alcohol, or drugs that you are now taking or plan to take during your treatment with buspirone hydrochloride tablets.
Inform your physician if you are pregnant, or if you are planning to become pregnant, or if you become pregnant while you are taking buspirone hydrochloride tablets.
Inform your physician if you are breast-feeding an infant.
Until you experience how this medication affects you, do not drive a car or operate potentially dangerous machinery.
You should take buspirone hydrochloride tablets consistently, either always with or always without food.
During your treatment with buspirone hydrochloride tablets, avoid drinking large amounts of grapefruit juice.
Medlineplus source text (exact source wording)
Take twice daily and take consistently, either always with food or always without food each time.
Take buspirone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may start you on a low dose of buspirone and gradually increase your dose, not more often than once every 2 to 3 days. It may take several weeks before you reach a dose that works for you.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking buspirone.
you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
remember that alcohol can add to the drowsiness caused by this drug. Do not drink alcohol while taking buspirone.
Take buspirone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may start you on a low dose of buspirone and gradually increase your dose, not more often than once every 2 to 3 days. It may take several weeks before you reach a dose that works for you.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking buspirone.
you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
remember that alcohol can add to the drowsiness caused by this drug. Do not drink alcohol while taking buspirone.
Alternatives
Class
Anxiolytic / antianxiety agent (class wording, not an openFDA EPC)
Class source
Label DESCRIPTION: 'an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs'; MedlinePlus: 'a class of medications called anxiolytics'
Note
No recommendation of one over another.
Frequently asked questions
Question
What is buspirone used for?
Answer
The label says it is 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.
Source section
INDICATIONS AND USAGE
Source
DailyMed AiPing buspirone label
Question
Should I take buspirone with food?
Answer
Take it consistently, either always with food or always without food. Food increases how much buspirone is absorbed, so the timing should be consistent.
Source section
DOSAGE AND ADMINISTRATION
Source
DailyMed AiPing buspirone label
Question
What if I miss a dose?
Answer
The label has no missed-dose instruction. MedlinePlus says to take it as soon as you remember, skip it if it is almost time for the next dose, and not take a double dose.
Source section
MedlinePlus 'What should I do if I forget a dose?'
Source
MedlinePlus
Question
Can I have grapefruit juice or alcohol with buspirone?
Answer
Avoid drinking large amounts of grapefruit juice, because it raised buspirone levels in a study (4.3-fold in Cmax; 9.2-fold in AUC). The label says it is prudent to avoid alcohol with buspirone, and MedlinePlus says alcohol can add to drowsiness.
Source section
PRECAUTIONS: Drug Interactions; General
Source
DailyMed AiPing buspirone label; MedlinePlus
Question
What are the common side effects?
Answer
The label lists dizziness, nausea, headache, nervousness, lightheadedness, and excitement as the more commonly observed events not seen at an equivalent incidence among placebo-treated patients. In trials dizziness was 12% with buspirone vs 3% with placebo, and nausea 8% vs 5%.
Source section
ADVERSE REACTIONS
Source
DailyMed AiPing buspirone label
Question
Can I take buspirone while pregnant or breastfeeding?
Answer
Adequate and well-controlled studies in pregnant women have not been done, so the label says it should be used during pregnancy only if clearly needed. Whether buspirone passes into human milk is not known, and the label says to avoid it in nursing women if clinically possible.
Source section
PRECAUTIONS - Pregnancy; Nursing Mothers
Source
DailyMed AiPing buspirone label
Question
What should I not take with buspirone?
Answer
Do not use an MAOI for depression with buspirone or within 14 days of stopping either one, and do not start buspirone while being treated with linezolid or intravenous methylene blue. Use with tryptophan is not recommended, and drugs such as erythromycin, itraconazole, nefazodone, diltiazem, verapamil and rifampin change buspirone levels.
Source section
CONTRAINDICATIONS; WARNINGS; Drug Interactions
Source
DailyMed AiPing buspirone label
Question
Is buspirone habit-forming?
Answer
The label says buspirone is not a controlled substance. In human and animal studies it showed no potential for abuse or diversion and no evidence that it causes tolerance or physical or psychological dependence, though physicians should still evaluate patients for a history of drug abuse.
Source section
DRUG ABUSE AND DEPENDENCE
Source
DailyMed AiPing buspirone label
Sources
- DailyMed SPL - Buspirone hydrochloride tablets, AiPing Pharmaceutical, Inc. (primary generic label)
Set id: 55810b17-4796-49d0-90e4-8e075d62eda4 · Label effective or revised date: Revised: 07/2026 · Dailymed version date: DailyMed list publish date Jul 31, 2026 · Fetched at: 2026-11-03 · Sections used: all (label is in the older non-highlights format, no numbered sections) - MedlinePlus Buspirone
Set id: n/a · Label effective or revised date: Last Revised - 03/15/2026 · Fetched at: 2026-11-03 · Sections used: all patient sections - openFDA drug label API
Set id: n/a · Label effective or revised date: n/a · Fetched at: 2026-11-03 · Sections used: pharm_class_epc query returned 'Nothing to count' (NOT FOUND) - Drugs@FDA
Fetched at: 2026-11-03
Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug