Buspirone

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Buspirone

Buspirone

Buspirone is a anti-anxiety medicine (anxiolytic, drug used to reduce anxiety) that is used to treat anxiety disorders primarily used to treat generalized anxiety disorder (GAD) or in the short-term treatment of symptoms of anxiety such as fear, tension, irritability, dizziness, pounding heartbeat, and other physical symptoms 1, 2. However, buspirone usually is not used for anxiety or tension caused by the stress of everyday life. Buspirone has been used off label to treat depression (often in combination with other agents) and as treatment for substance abuse, post-traumatic stress disorder (PTSD), bruxism (teeth grinding and clenching), tardive dyskinesia (a neurological syndrome that involves involuntary or out of your control movements that can develop if you take an antipsychotic medication and/or other types of medications) and other psychiatric and neurological conditions, but its efficacy in these situations has not been proven. Buspirone was approved for use in the United States in 1986 3. Buspirone works by changing the amounts of certain natural neurotransmitters in your brain. Buspirone appears to interact with dopamine and serotonin (5‐HT1A) receptors, but its precise mechanism of action to relieve the symptoms of anxiety is not known.

It is important to recognize that buspirone has no use in treating withdrawal symptoms from benzodiazepines, barbiturates, or alcohol 1. This relates to the lack of gamma-aminobutyric acid (GABA) receptor activity. Furthermore, the effects of buspirone have been shown to diminish in patients who have had previous treatment with benzodiazepines 4. A randomized controlled trial concluded that buspirone improves central apnea, apnoea-hypopnoea index (AHI), and oxygen saturation in patients with heart failure 5. Another study identified buspirone as a useful agent for treating gastroparesis and functional dyspepsia 6. However, significant research in clinical trials is necessary before approving the use of buspirone for the indications mentioned earlier in clinical practice.

Buspirone is available in tablets of 5, 10, 15 and 30 mg in several generic forms and under the brand name Buspar. Buspirone usually is taken twice daily and must be taken consistently, either always with food or always without food each time. Typical doses are 15 to 30 mg daily in divided doses. The initial recommended dose for generalized anxiety disorder (GAD) treatment is 15 mg daily, given as either 7.5 mg twice per day or 5 mg three times per day. Every 2 to 3 days, the dosage may be increased by 5 mg until the desired clinical response is achieved. The maximum daily dosage is 60 mg per day. In clinical trials, a typical range of therapeutic effects was between 20 to 30 mg per day in divided doses.

Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. 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 (2 to 4 weeks) before you reach a dose that works for you 1. Your doctor will assess your level of anxiety using the GAD-7 (general anxiety disorder-7) tool at baseline and follow-up visits to assess response to therapy. Similarly, your doctor can use the Hamilton Anxiety Scale (HAM-A) to objectify and rate your anxiety severity 7, 8.

Common side effects of buspirone include drowsiness, dizziness, headache, nausea, abdominal discomfort and rash. Dizziness is a common side effect that occurs in over 10% of patients 9.

Of note, buspirone has minimal sexual side effects when compared to selective serotonin reuptake inhibitors (SSRI). Buspirone has even been shown to help relieve the adverse sexual effects of SSRIs when given as an “augmenting agent” (a medication added to an existing antidepressant treatment to potentially improve its effectiveness) 10. Patients should receive a warning about the possibility of central nervous system depression. In addition, clinicians should inform patients of the rare potential for akathisia (a neuropsychiatric movement disorder characterized by a subjective feeling of inner restlessness and an inability to sit still, often accompanied by a compulsion to move, particularly in the legs) likely due to central dopamine antagonism and serotonin syndrome 2. Postmarketing surveillance reports cases of somnambulism (sleepwalking) associated with buspirone. However, altered neurobiology due to psychiatric disorders should also be considered 11. Long QT syndrome (LQTS) has also been reported in patients with preexisting heart conditions 12.

How does buspirone work?

Buspirone is classified in the azapirone drug class 13, 14.. Buspirone appears to interact with dopamine and serotonin (5‐HT1A) receptors, but its precise mechanism of action to relieve the symptoms of anxiety is not known. Buspirone has a strong affinity for serotonin 5‐HT1A receptors, where it acts as a partial agonist, which some researchers believe produces the preponderance of clinical effects. It also has a weak affinity for serotonin 5HT2 receptors and acts as a weak antagonist of dopamine D2 autoreceptors. There is no effect on benzodiazepine GABA receptors. The underlying mechanism behind how the partial serotonin 5‐HT1A receptor agonism translates into clinical results remains largely unknown. It is proposed from increased serotonergic activity in the amygdala and other parts of the brain’s anxiety/fear circuitry. Due to the delayed anxiolytic effects seen clinically, buspirone likely provides relief through adaptations in serotonin 5‐HT1A receptors 15.

Absorption

Buspirone is rapidly absorbed and undergoes extensive first-pass metabolism. Peak plasma levels are attained within 40 to 90 minutes 16.

Distribution

Buspirone has approximately 86% plasma protein binding.

Metabolism

Buspirone is metabolized primarily by oxidation by P450 system (CYP 3A4) and converts to hydroxylated derivatives and a pharmacologically active metabolite, 1-pyrimidinylpiperazine (1-PP) 17.

Excretion

The elimination half-life of unchanged buspirone is approximately 2 to 3 hours. Buspirone is excreted in the urine as metabolites(29% to 63%); fecal excretion accounts for 18% to 38% of the dose.

Before taking Buspirone

You should not use buspirone if you are allergic to buspirone, any other medications, or any of the ingredients in buspirone tablets.

Do not use buspirone within 14 days before or 14 days after you have used an monoamine oxidase (MAO) inhibitor. A dangerous drug interaction could occur. Monoamine oxidase (MAO) inhibitors include isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, rasagiline, phenelzine (Nardil), selegiline (Emsam, Zelapar), and tranylcypromine (Parnate). You must wait at least 14 days after stopping an monoamine oxidase (MAO) inhibitor before you take buspirone.

You should know that buspirone may make you drowsy. Do not drive a car or operate machinery until you know how buspirone affects you. Remember that alcohol can add to the drowsiness caused by buspirone. Do not drink alcohol while taking buspirone. Alcohol use can worsen any sedation, and its use requires strict monitoring as well 18

To make sure buspirone is safe for you, tell your doctor if you have ever had:

  • Kidney disease: The bioavailability of buspirone is increased fourfold in patients with kidney impairment (creatine clearance = 10 to 70 mL/min/1.73 m); consequently, consider dose reduction in patients with kidney impairment.
  • Liver disease: The measured bioavailability (using the steady-state area under the curve) increased 13-fold in patients with liver impairment; consider dose reduction in patients with liver impairment.
  • History of alcohol or drug abuse.

The following nonprescription product may interact with buspirone: cimetidine (Tagamet). 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 doctor.

Grapefruit and grapefruit juice may interact with buspirone and lead to unwanted side effects 19. Grapefruit juice substantially increases plasma concentrations of buspirone.

If you become pregnant, plan to become pregnant, or are breast-feeding while taking buspirone, tell your doctor.

If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking buspirone.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children

Appropriate studies on the relationship of age to the effects of buspirone have not been performed in the pediatric population. However, no pediatric-specific problems have been documented to date.

Elderly

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of buspirone in the elderly.

Pregnancy

Buspirone is a Category B risk in pregnancy. On June 30, 2015, the FDA began implementation of the Pregnancy and Lactation Labeling Rule, which replaced the pregnancy letter category system (A, B, C, D, and X) with integrated narrative summaries of the risks of using a drug or biological product during pregnancy and lactation. The effect of buspirone use during pregnancy on labor and delivery is unknown. However, reproductive studies in rats did not cause any adverse effects on animals 20.

It is not known if buspirone can make it harder to get pregnant 21.

Miscarriage is common and can occur in any pregnancy for many different reasons. Studies have not been done to see if buspirone can increase the chance of miscarriage 21.

Every pregnancy starts out with a 3-5% chance of having a birth defect. This is called the background risk. It is not known if buspirone can increase the chance of birth defects above the background risk. Information from a pregnancy registry found no birth defects among 72 infants exposed to buspirone during pregnancy.

Studies have not been done to see if buspirone can increase the chance of other pregnancy-related problems, such as preterm delivery (birth before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth).

The use of some medications during pregnancy can cause temporary symptoms in newborns soon after birth 21. These symptoms are sometimes referred to as withdrawal. There is a report of one infant with decreased growth, tremors, low muscle tone, low blood sugar, and trouble feeding. The infant was exposed to buspirone, other medications, and cigarette smoke during pregnancy. It is not known if the symptoms in the baby were due to buspirone, other exposures, or a combination of factors. It is important that your doctor know you are taking buspirone so your baby can be monitored if needed.

Studies have not been done to see if buspirone can increase the chance of behavior or learning issues for the child 21.

Breastfeeding

Information on the use of buspirone in breastfeeding is limited 21. Limited data indicate that maternal doses of buspirone up to 45 mg daily produce low levels of milk. No information is available on the long-term use of buspirone during breastfeeding; an alternate medication may be preferred, particularly while nursing a newborn or preterm infant 22.

One report included a woman who took buspirone (15mg/ 3 times a day) while breastfeeding. The levels of the medication were checked once and were too low to be found in the breastmilk. There are reports that looked at effects of buspirone in breastfed infants. One report found no short-term side effects in an 11-week-old baby whose mother was taking 2 medications including 10 mg/day of buspirone. Another report described seizure-like activity in a 3-week-old infant. However, the authors suggested that if one of the 3 prescription medications that the mother was taking contributed to the effects seen in the baby, it was unlikely to be buspirone. If you suspect the baby has any symptoms, contact the child’s doctor. Be sure to talk to your doctor about all your breastfeeding questions.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking Buspirone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using Buspirone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Isocarboxazid
  • Levoketoconazole
  • Phenelzine
  • Tranylcypromine

Using Buspirone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adagrasib
  • Alfentanil
  • Almotriptan
  • Alprazolam
  • Amitriptyline
  • Amoxapine
  • Amphetamine
  • Avacopan
  • Benzhydrocodone
  • Benzphetamine
  • Bromazepam
  • Bromopride
  • Buprenorphine
  • Bupropion
  • Butalbital
  • Butorphanol
  • Calcium Oxybate
  • Cannabidiol
  • Cannabis
  • Carbamazepine
  • Carbidopa
  • Carbinoxamine
  • Ceritinib
  • Cetirizine
  • Citalopram
  • Clarithromycin
  • Clonazepam
  • Clorgyline
  • Clozapine
  • Cobicistat
  • Codeine
  • Conivaptan
  • Cyclobenzaprine
  • Cyproheptadine
  • Dabrafenib
  • Daridorexant
  • Desvenlafaxine
  • Dexmedetomidine
  • Dextroamphetamine
  • Dextromethorphan
  • Plus many more not on this list.

Using Buspirone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Apalutamide
  • Diltiazem
  • Erythromycin
  • Ginkgo
  • Haloperidol
  • Mavacamten
  • Nefazodone
  • Rifampin
  • St John’s Wort
  • Tizanidine
  • Verapamil

Buspirone contraindications

Contraindications for Buspirone include the following:

  • History of hypersensitivity reaction with buspirone in the past
  • Avoid the use of monoamine oxidase (MAO) inhibitors within 14 days before or after buspirone therapy. Using monoamine oxidase inhibitors (MAOI) such as isocarboxazid (Marplan), rasagiline, phenelzine (Nardil), selegiline (Emsam, Zelapar), and tranylcypromine (Parnate), within 14 days before or after buspirone therapy can lead to the risk of developing serotonin syndrome and/or elevated blood pressure 23. You must wait at least 14 days after stopping an monoamine oxidase (MAO) inhibitor before you take buspirone.
  • Avoid buspirone in patients receiving reversible MAOIs such as linezolid (Zyvox) or IV methylene blue due to the risk of serotonin syndrome 24. You must wait at least 14 days after stopping an monoamine oxidase (MAO) inhibitor before you take buspirone.

What is Buspirone used for?

Buspirone is a anti-anxiety medicine (anxiolytic, drug used to reduce anxiety) that is used to treat anxiety disorders primarily used to treat generalized anxiety disorder (GAD) or in the short-term treatment of symptoms of anxiety such as fear, tension, irritability, dizziness, pounding heartbeat, and other physical symptoms. However, buspirone usually is not used for anxiety or tension caused by the stress of everyday life. Buspirone has been used off label to treat depression (often in combination with other agents) and as treatment for substance abuse, post-traumatic stress disorder (PTSD), bruxism (teeth grinding and clenching), tardive dyskinesia (a neurological syndrome that involves involuntary or out of your control movements that can develop if you take an antipsychotic medication and/or other types of medications) and other psychiatric and neurological conditions, but its efficacy in these situations has not been proven.

United States Food and Drug Administration-Approved (FDA) Indication

Buspirone is mainly used to treat anxiety disorders primarily used to treat generalized anxiety disorder (GAD) or in the short-term treatment of symptoms of anxiety such as fear, tension, irritability, dizziness, pounding heartbeat, and other physical symptoms. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis corresponds to generalized anxiety disorder (GAD) 25. Generalized anxiety disorder (GAD) is a mental health condition that causes fear, a constant feeling of being overwhelmed and excessive worry about everyday things such as job responsibilities, health or chores. Generalized anxiety disorder (GAD) can affect children and adults. However, buspirone has little efficacy as an acute anxiolytic as the clinical effect typically takes 2 to 4 weeks to achieve. It is as effective as benzodiazepine treatment for generalized anxiety disorder (GAD) 15.

Buspirone is also used as a second-line agent behind selective serotonin reuptake inhibitors (SSRIs) when a patient does not respond to or cannot tolerate the side effects of SSRIs. SSRIs (selective serotonin reuptake inhibitors) are medications that are the most commonly prescribed antidepressant used to treat depression, anxiety disorders, obsessive-compulsive disorder (OCD), panic disorders, and eating disorder bulimia nervosa and other mental health conditions 26, 27.

Buspirone has also been used as an “augmentation agent” (a medication added to an existing antidepressant treatment to potentially improve its effectiveness) to reduce SSRI’s sexual side effects such as such as lessened sexual desire, trouble reaching orgasm or trouble getting and keeping an erection. Unlike benzodiazepines and barbiturates, there is no associated risk of physical dependence or withdrawal with buspirone use due to the lack of effects on gamma-aminobutyric acid (GABA) receptors.

Off-label Clinical Use

Buspirone is used as an “augmentation agent” (a medication added to an existing antidepressant treatment to potentially improve its effectiveness) in the treatment of depression (major depressive disorder). The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial showed evidence suggesting that buspirone could be effective as “augmentation agent”, alongside SSRIs, for depression (major depressive disorder). Further studies have also found some utility in subduing the sexual side effects such as such as lessened sexual desire, trouble reaching orgasm or trouble getting and keeping an erection of SSRIs and use as a single agent for the treatment of depression. Although the FDA does not approve these uses, evidence supports that buspirone combined with melatonin can treat major depressive disorder and promote neurogenesis (growth and development of nervous tissue) 28, 29.

Buspirone dosage

The dose of Buspirone will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of Buspirone. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets)

  • For anxiety
    • Adults: At first, 7.5 mg two times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg a day.
      • Maintenance dose: The daily dose may be increased in 5 mg increments every 2 to 3 days up to 20 to 60 mg/day in divided doses.
      • Maximum dose: 60 mg per day
    • Children: Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of Buspirone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Buspirone side effects

Buspirone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • Dizziness is a common side effect that occurs in over 10% of patients 9.
  • Central nervous system (brain and spinal cord): Abnormal dreams, ataxia, confusion, dizziness, drowsiness, excitement, headache, nervousness, numbness, outbursts of anger, paresthesia
  • Blurred vision
  • Tinnitus
  • Chest pain
  • Nasal congestion
  • Diaphoresis, skin rash
  • Diarrhea, nausea, sore throat
  • Musculoskeletal pain, tremor, weakness
  • Isolated cases of liver serum enzyme elevations without jaundice 30
  • nausea
  • diarrhea
  • headache
  • excitement
  • confusion
  • fatigue
  • nervousness
  • difficulty falling asleep or staying asleep
  • feelings of anger or hostility
  • lightheadedness
  • headache
  • weakness
  • numbness
  • increased sweating

Some side effects can be serious. If you experience any of these symptoms, see your doctor immediately:

  • rash
  • hives
  • itching
  • 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.

Symptoms of buspirone overdose may include:

  • nausea
  • vomiting
  • dizziness
  • drowsiness
  • blurred vision
  • upset stomach.

In case of buspirone overdose, seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

There have been no deaths reported from a buspirone overdose alone 1. In pharmacological trials, healthy male patients were given Buspirone up to 375 mg daily and developed nausea, vomiting, dizziness, drowsiness, miosis, and gastric distress. While buspirone overdose typically resolves with complete recovery, high suspicion of other medication overdoses should be maintained and investigated 31, 32. In a literature review, multiple reports of movement disorders, including tardive dyskinesia (uncontrolled, involuntary muscle movement), akathisia (a movement disorder characterized by a subjective feeling of inner restlessness and an inability to sit still, often accompanied by a compulsion to move, particularly in the legs), myoclonus (sudden, brief, involuntary jerks or spasms of a muscle or group of muscles, often described as a “shock-like” movement), parkinsonism (a collection of movement disorders characterized by symptoms like tremors, slow movements, and stiffness) and dystonia (a neurological movement disorder characterized by involuntary muscle contractions causing twisting, repetitive movements, and abnormal postures, which can be painful and interfere with daily activities) have been reported 1.

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