BREXPIPRAZOLE: AT THE CROSSROADS OF NEUROPSYCHIATRIC SYMPTOMS
Faculty:
L. Austin Fredrickson, MD, FACP
L. Austin Fredrickson is an Associate Professor of Internal Medicine at Northeast Ohio Medical University, where he serves as core faculty and teaches diagnostics, therapeutics, clinical skills, and health humanities. He is board-certified in general internal medicine and practices rural primary care. 
Sandra Rogers, MD
Sandra Rogers is a primary care physician in Texas. She is board-certified through the American Board of Family Medicine and the American Board of Internal Medicine. She completed her dual residency at Eastern Virginia Medical School in Norfolk, Virginia. She has been practicing in Allen, Texas, for over 20 years.
Kristina (Tia) Neu, RN
Kristina (Tia) Neu is a licensed Registered Nurse and author currently developing in-service training for healthcare professionals. She is a National Board-Certified Health & Wellness and Lifestyle Medicine Coach. Her work experience includes work in several areas of the healthcare profession, including psychiatric nursing, medical nursing, motivational health coaching, chronic case management, dental hygiene, cardiac technician, and surgical technician.
Pamela Sardo, PharmD, BS
Pamela Sardo, PharmD, BS, is a freelance medical writer and licensed pharmacist. She is the founder and principal at Sardo Solutions in Texas. Pam received her BS from the University of Connecticut and her PharmD from the University of Rhode Island. Pam’s career spans many years in retail, clinics, hospitals, long-term care, Veterans Affairs, and managed health care responsibilities across a broad range of therapeutic classes and disease states.
Abstract
Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults, as well as the treatment of schizophrenia in patients aged 13 years and older. In 2023, the FDA approved the original form of brexpiprazole for the treatment of agitation symptoms associated with dementia due to Alzheimer’s disease. Brexpiprazole may also have promise in the treatment of unipolar and bipolar patients with treatment-resistant depression when used in combination with other drugs. Notable adverse effects include akathisia and weight gain. Data is limited comparing brexpiprazole to other antipsychotics, but it should be considered in patients who have not tolerated other antipsychotics well.
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This activity was planned by and for the healthcare team, and learners will receive 2 Interprofessional Continuing Education (IPCE) credits for learning and change.
Joint Universal Activity Number: The Joint Accreditation Universal Activity Numbers assigned to this activity are as follows:
Pharmacists: JA4008424-0000-26-028-H01-P
Pharmacy Technicians: JA4008424-0000-26-028-H01-T
Credits: 2 contact hour(s) (0.2 CEU(s)) of continuing education credit.
Credit Types:
IPCE Credits - 2 Credits
AAPA Category 1 Credit™️ - 2 Credits
AMA PRA Category 1 Credit™️ - 2 Credits
Pharmacy - 2 Credits
Type of Activity: Knowledge
Media: Computer-Based Training (i.e., online courses)
Estimated time to complete activity: 2 contact hour(s) (0.2 CEU(s)), including Course Test and course evaluation.
Release Date: March 14, 2026 Expiration Date: March 14, 2029
Target Audience: This educational activity is for Physicians, Physician Assistants, Pharmacists, and Pharmacy Technicians
How to Earn Credit: From March 14, 2026, through March 14, 2029, participants must:
Read the “learning objectives” and “author and planning team disclosures;”
Take the “Educational Activity Pre-Test;”
Study the section entitled “Educational Activity;” and
Complete the Educational Activity Post-Test and Activity Evaluation. The Educational Activity Post-Test will be graded automatically. Following successful completion of the Educational Activity Post-Test with a score of 70% or higher, a statement of participation will be made available immediately. (No partial credit will be given.)
CME Credit: Credit for this course will be uploaded to CPE Monitor® for pharmacists. Physicians may receive AMA PRA Category 1 Credit™️ and use these credits toward Maintenance of Certification (MOC) requirements. Physician Assistants may earn AAPA Category 1 CME credit, reportable through PA Portfolio. All learners shall verify their individual licensing board’s specific requirements and eligibility criteria.
Statement of Need
Brexpiprazole is a newer second-generation antipsychotic with expanding uses in schizophrenia, major depressive disorder, and agitation associated with Alzheimer’s dementia. Clinicians need to understand the pharmacologic profile and real-world outcomes of this treatment option relative to other treatment options. An individualized approach to treatment and shared decision-making is important. Clinical decision-making can be complicated because head-to-head published data is limited and nuanced. Brexpiprazole’s distinct serotonin-dopamine receptor binding and partial agonist activity may translate into distinct neuromotor, metabolic, and sedation effects. Healthcare professionals must weigh risks and benefits and recognize contraindications, boxed warnings, and serious adverse effects. Evidence-based education is needed so healthcare teams can prescribe and monitor individualized dosing, optimize safety considerations, and counsel patients who may be candidates for brexpiprazole.
Learning Objectives: Upon completion of this educational activity, participants should be able to:
Describe the basic pharmacological profile and clinical outcomes of brexpiprazole treatment
Identify the uses for brexpiprazole
Compare the benefits and risks of brexpiprazole use for patients with chronic mental illness compared to other antipsychotics
Identify the contraindications and potential side effects of brexpiprazole
Disclosures
The following individuals were involved in planning, developing, and/or authoring this activity: L. Austin Fredrickson, MD, FACP; Sandra Rogers, MD; Kristina (Tia) Neu, RN; and Pamela Sardo, PharmD, BS. None of the individuals involved in developing this activity has a conflict of interest or financial relationships related to the subject matter. There are no financial relationships or commercial or financial support relevant to this activity to report or disclose by RxCe.com or any of the individuals involved in the development of this activity.
© RxCe.com LLC 2026: All rights reserved. No reproduction of all or part of any content herein is allowed without the prior, written permission of RxCe.com LLC.
Educational Activity Pre-Test
There is a brexpiprazole product that is now FDA-approved to treat
agitation symptoms associated with dementia due to Alzheimer’s disease.
all dementia-related psychoses.
Post-Traumatic Stress Disorder (PTSD).
somatic symptom disorder (SSD).
A mother who is taking brexpiprazole and who plans to breastfeed her newborn should know that
brexpiprazole is NOT excreted in breast milk.
brexpiprazole is contraindicated in women who are breastfeeding.
there is no relevant, published information on brexpiprazole and breastfeeding.
brexpiprazole has an RID of > 10%.
The incidence of akathisia increases with
an increase in the brexpiprazole dose.
a reduction in the brexpiprazole dose.
the concomitant administration of brexpiprazole and a benzodiazepine.
the concomitant administration of brexpiprazole and a beta-blocker.
Educational Activity
Brexpiprazole: At the Crossroads of Neuropsychiatric Symptoms
Introduction
Brexpiprazole is an atypical antipsychotic currently indicated for use as an adjunctive therapy for the treatment of major depressive disorder in adults, as well as the treatment of schizophrenia in adults and in patients ages 13 and older. The original form of the drug was recently approved for the treatment of agitation associated with dementia due to Alzheimer's disease. Brexpiprazole is also being studied as a possible treatment for unipolar and bipolar patients with treatment-resistant depression when used in combination with other drugs.
History of Brexpiprazole
In 2015, brexpiprazole (Rexulti®) was approved by the Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD) in adults, as well as the treatment of schizophrenia.1,2 In 2021, brexpiprazole was FDA-approved to treat schizophrenia in patients aged 13 and older.3 In 2023, the FDA approved the original form of brexpiprazole for the treatment of agitation symptoms associated with dementia due to Alzheimer’s Disease.4 Generic brexpiprazole formulations’ labeled uses are limited to use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) and schizophrenia in adults.5
Compared with some of the newer second-generation antipsychotics, double-blind, placebo-controlled trials of brexpiprazole identified a more balanced serotonin/dopamine receptor binding profile, leading to fewer neuromotor adverse effects.6 There is also less sedation and less weight gain reported with brexpiprazole.6 Clinical studies on the risk-benefit profile of brexpiprazole are discussed in later sections.
Brexpiprazole and other similar drugs are referred to as second-generation or atypical antipsychotics because they were developed 20-30 years after the first antipsychotics, such as haloperidol and thioridazine, had been in use.7 Atypical antipsychotics are less likely to cause adverse effects like extrapyramidal symptoms (EPS) that are relatively common for typical antipsychotics like haloperidol and thioridazine.6,7
Atypical antipsychotics are also distinct from typical antipsychotics in their pharmacologic actions, and these differences influence their adverse effect profile and clinical effectiveness. The primary mechanism of action of the typical antipsychotics is dopamine2 receptor antagonism.6,7 Atypical antipsychotics have this effect, as well, but to a lesser degree; the binding of the atypical antipsychotics to dopamine receptors may not be as strong or as lasting as for the typical antipsychotics, and this may explain the decreased risk for EPS compared to the typical antipsychotics.6,7 In addition, atypical antipsychotics are powerful serotonin receptor antagonists, and their ability to act as serotonin receptor antagonists is often stronger than their dopamine2 receptor blockade.6,7
Pharmacological Profile
Brexpiprazole exerts its primary mechanism of action as a partial agonist at D2 and 5-HT1A receptors, with antagonistic activity at 5-HT2A receptors.6,7 Brexpiprazole also has partial agonist activity at D3 and 5-HT1A receptors, antagonist activity at 5-HT2B, α1A, α1B, α1D, and α2C receptors, and affinity for H1 receptor and M1 receptors.6,7 The partial agonism of D2 receptors theoretically reduces dopamine output when the dopamine concentrations are high and increases dopamine output when dopamine concentrations are low. These two actions are thought to improve the positive and negative symptoms of schizophrenia.2,6,7 The partial agonist activity at 5-HT1A receptors is what is responsible for mood, anxiety, and cognitive changes.2,6,7 Agonistic activity at 5-HT2A receptors enhances dopamine release in certain brain regions, thereby reducing motor side effects. Lastly, blockade of receptor α1B may reduce agitation associated with dementia and reduce motor side effects such as akathisia.2,6,7
The mean half-life of brexpiprazole is 91 hours, and that of its major metabolite is 86 hours.2 The major metabolite of DM-3411 is not considered to contribute to the therapeutic effects of brexpiprazole.2 After a single dose, the peak plasma concentration was observed at 4 hours post-administration, with 95% bioavailability.2 A steady state was achieved within 10-12 days of dosing.2 Brexpiprazole is 99% protein-bound, and the protein binding is not affected by renal or hepatic impairment.2 Nearly half of the metabolized brexpiprazole will be eliminated through the GI tract, and one-fourth will be renally eliminated. 2
Brexpiprazole Uses
Brexpiprazole is available in tablet strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg.2 Dosing should be individualized, and is typically once daily, with or without food. Prescribing information for schizophrenia and MDD may be obtained from the package inserts or drug summary.2
Labeled Uses
Brexpiprazole is approved to treat schizophrenia in adults and in patients ages 13 and older.2 For patients diagnosed with schizophrenia, the treatment goal is a reduction in positive and negative symptoms, with the patient recognizing that the symptoms may not be eliminated completely. If brexpiprazole does not work as monotherapy, additional add-on therapies include valproic acid, mood-stabilizing anticonvulsants, lithium, topiramate, and benzodiazepines.1,2
Brexpiprazole is approved as an adjunctive therapy for the treatment of major depressive disorder in adults.2 For the adjunctive treatment of MDD, treatment should continue until symptoms are significantly reduced or gone, and treatment should continue for 1 year if it is the first episode of depression, but may need to be indefinite in the second or subsequent episodes.1,2
Brexpiprazole is approved for the treatment of agitation associated with dementia due to Alzheimer's disease. For the treatment of agitation associated with Alzheimer's dementia, the primary efficacy endpoint is a reduction from baseline in the Cohen-Mansfield Agitation Inventory total (CMAI).2
Unlabeled Uses
Brexpiprazole is also used off-label for the following conditions:
The treatment of borderline personality disorder (BPD).10 Suicidality, aggression, and substance abuse are common presentations of BPD.10
The treatment of bipolar disorder.11 It is used in cases of bipolar depression, bipolar maintenance, or acute mania/mixed episodes.11
As an adjunctive treatment of Post-Traumatic Stress Disorder (PTSD).12,13 In September 2025, the FDA rejected a supplemental New Drug Application for brexpiprazole combined with sertraline for PTSD treatment, citing a lack of substantial evidence of effectiveness despite clinical trial data showing symptom reduction in some studies.14
While specific Alzheimer's agitation is approved, it is used off-label for broader behavioral symptoms in various dementias, e.g., behavioral and psychological symptoms of dementia (BPSD).15 Brexpiprazole’s package insert states that it is not an approved treatment for patients with dementia-related psychosis;2 however, it has been used as an off-label treatment for severe BPSD. The FDA has required a boxed warning for antipsychotic drugs used to treat geriatric patients for dementia-related psychosis, noting increased death in this population.2
The treatment of somatic symptom disorder (SSD) as an adjunct to SSRIs and general psychotic disorders.16
Dosing Adjustments
Several dosing adjustments need to be considered involving the CYP2D6 and CYP3A4 enzymes. In patients with reduced CYP2D6 activity, a half-normal dose of brexpiprazole is recommended. If a patient has decreased CYP2D6 activity and is also taking a strong CYP3A4 inhibitor, one-fourth the normal dose should be used. In a patient taking a strong CYP2D6 or CYP3A4 inhibitor, half the usual dose should be used. When patients are taking a strong CYP2D6 inhibitor and a strong CYP3A4 inhibitor, the dose should be reduced to one-quarter of the normal dose. Patients taking drugs that are strong CYP3A4 inducers will need the dose doubled over two weeks.2
Brexpiprazole is metabolized by the liver, and the area under the curve (AUC) of brexpiprazole is increased in patients who have moderate to severe hepatic impairment.2 For patients with moderate to severe hepatic impairment, Child-Pugh category B or C, the maximum daily dose is 2 mg for the treatment of MDD and 3 mg for the treatment of schizophrenia.2 Liver test abnormalities reportedly occurred in ~ 1% of patients on long-term therapy with brexpiprazole, but the risk for this was equivalent to that of patients taking a placebo. There is no published information on acute liver injury caused by brexpiprazole.17
Renal impairment increases the AUC of brexpiprazole when the creatinine clearance (CrCL) is < 60 mL/minute. The maximum daily dose should be adjusted to 2 mg for MDD and 3 mg for schizophrenia.2
Contraindications, Adverse Effects, Warnings, and Precautions
Brexpiprazole’s prescribing information states that it is contraindicated in patients with hypersensitivity to brexpiprazole or any of its components.2 A patient taking brexpiprazole may present with a rash, facial swelling, or urticaria. Anaphylaxis has been reported with brexpiprazole use.2
Brexpiprazole use includes several warnings and precautions relevant for shared decision-making. Key warnings include the following:2,18-21
An increased risk of death in elderly patients with dementia-related psychosis.
An increased risk of suicidal thoughts and actions in pediatric and young adult patients.
Potential serious side effects include neuroleptic malignant syndrome, tardive dyskinesia, and metabolic changes.
Many of these adverse effects have not been reported with the use of brexpiprazole, but it is structurally and pharmacologically similar to other atypical antipsychotics.7,22 Moreover, because it is comparatively new, it is possible that with more clinical use, some of the listed potential adverse effects may be reported with the use of brexpiprazole. A prudent healthcare professional should evaluate a patient for risk factors associated with these effects before prescribing brexpiprazole and then monitor the patient during the therapeutic period.
The most common adverse reactions seen with the use of brexpiprazole are weight gain and akathisia. These adverse effects are also linked to metabolic changes, such as dyslipidemia and hyperglycemia.2,7 Adverse effects from brexpiprazole, such as dose-related akathisia, increased serum triglycerides, and weight gain, have been reported with incidence rates of >10%.2
Other warnings and precautions that should be considered when prescribing brexpiprazole are “cerebrovascular adverse reactions in elderly patients with dementia-related psychosis, neuroleptic malignant syndrome, tardive dyskinesia, leukopenia, orthostatic hypotension, and seizures.”7 There are boxed warnings and precautions listed for pregnant women.2,7 As a consequence, precautions should be taken in individuals with the following health conditions or a history of a prior adverse response to brexpiprazole.2,7
Central Nervous System
Brexpiprazole may cause central nervous system (CNS) depression. Additionally, EPS, acute dystonia, akathisia, Parkinsonism, and tardive dyskinesia are well-known adverse effects of the atypical antipsychotic.2,23,24 Akathisia has been reported to occur in 4.0%-14% of patients.2 The dose of brexpiprazole and the incidence of akathisia are correlated; as the dose increases, so does the incidence of akathisia. Because of the dose/risk relationship, treatment of brexpiprazole-induced akathisia may begin with a dose reduction.2,25,26
Akathisia typically starts several days after the patient begins taking an antipsychotic, with 50% of cases developing within a month, and 90% developing within three months after the first dose.27 However, Stroup and Gray (2018) stated that while akathisia usually develops gradually during the days to weeks after treatment begins, it can present more acutely.28 Beta-blockers, benzodiazepines, or 5-HT2A antagonists can be used for the treatment of akathisia. Drug-induced Parkinsonism can be treated with benztropine, trihexyphenidyl, or amantadine. Lastly, tardive dyskinesia can be treated with valbenazine or deutetrabenazine,27 but the clinical utility of these agents is unclear.28
Hyperglycemia and Weight Gain
Hyperglycemia has been reported as an adverse effect of atypical antipsychotics, including brexpiprazole, and severe cases of hyperglycemia causing hyperosmolar coma, ketoacidosis, and death have occurred with the use of the atypical antipsychotics.2 Patients who have diabetes or who are prediabetic are more likely to develop hyperglycemia from an atypical antipsychotic.29 Hyperglycemia can resolve after discontinuing the use of the drug, with some patients requiring treatment of diabetes after discontinuation of therapy.29 The prescribing information for brexpiprazole states that there have been reports of hyperglycemia in patients treated with brexpiprazole, but no other published information on the topic was located.2
During clinical trials of patients with MDD, weight gain of ≥7% of body weight was reported in 2% to 5% of patients taking brexpiprazole and in 2% of patients receiving a placebo.2 During clinical trials of patients who had schizophrenia, a weight gain of ≥ 7% of body weight was reported in 10%-11% of patients taking the drug and in 4% of patients receiving a placebo.2 In open-label studies, 30% of patients who had MDD and 20% of patients who had schizophrenia had a weight gain of ≥ 7% of body weight.2
Schizophrenia and MDD patients treated with brexpiprazole have experienced weight gain; however, brexpiprazole may be grouped among antipsychotics with “the lowest propensity to induce weight increase in schizophrenia and in MDD.”30
Metformin is a common strategy used to help prevent or reverse antipsychotic-induced weight gain. Lifestyle modifications should also be a focus for patients with the potential for medication-related weight gain.
Cardiovascular
The risk for orthostatic hypotension from brexpiprazole appears to be greatest at treatment initiation or when the dose is increased.2 Brexpiprazole should be used cautiously in patients who cannot tolerate a sudden drop in blood pressure, who have cardiovascular disease, have cerebrovascular disease, are chronically dehydrated, or are taking blood pressure-lowering drugs.2
The clinical trials for MDD reported a 0.1% incidence of orthostatic hypotension in the brexpiprazole group, compared with 0.0% in the placebo group.2 The clinical trials for schizophrenia observed a 0.4% incidence of orthostatic hypotension for the brexpiprazole group compared to 0.2% of the placebo group.2 The overall incidence of syncope was 0.1% for brexpiprazole compared to 0% in all placebo groups.2
Falls
Brexpiprazole and other atypical antipsychotics can cause orthostatic hypotension, CNS depression, motor instability, and sensory instability. These adverse effects increase the risk for falls, particularly in elderly patients.2 Fall risk assessments should be completed upon initiation of brexpiprazole and reevaluated for long-term use.
Gastrointestinal
Antipsychotics have been associated with esophageal dysmotility and aspiration. Brexpiprazole should be used cautiously in patients who are at risk for aspiration, who have Alzheimer's disease or dementia, or patients > 75 years old.2
Dyslipidemia
Atypical antipsychotics, including brexpiprazole, can significantly increase serum triglyceride levels.2,31 Unlike some of the other atypical antipsychotics, brexpiprazole does not cause significant increases in fasting serum cholesterol, high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol.2
Seizure Disorder
Atypical antipsychotics may lower the seizure threshold, and seizures associated with the use of brexpiprazole have been reported.2,31 Brexpiprazole should be used cautiously in patients who have a seizure disorder or may be at risk for seizures or are taking a medication that causes seizures or lowers the seizure threshold.2
Hematologic
Agranulocytosis, leukopenia, and neutropenia have been reported to be temporally associated with the use of antipsychotics.2,31 Possible risk factors for hematologic adverse effects include a pre-existing low white blood cell (WBC) count or absolute neutrophil count (ANC), and drug-induced leukopenia or neutropenia.2 Blood counts should be periodically measured if the patient has risk factors for these dyscrasias.2 If the patient has signs of blood dyscrasia or if the ANC is <1,000/mm3, drug use should be discontinued.2 For patients who have had drug-induced leukopenia or have a low ANC or WBC, the complete blood count (CBC) should be checked at baseline and frequently during the first few months of therapy.2
Neuroleptic Malignant Syndrome
Atypical antipsychotics can cause neuroleptic malignant syndrome (NMS), a rare and potentially fatal adverse drug reaction characterized by autonomic instability, hyperthermia, muscle rigidity, and neurological changes.2 Neuroleptic malignant syndrome may occur after rapid dose titration, or because of a higher total daily drug dose, but it usually occurs within the typical therapeutic dosage range of antipsychotics.29 There is currently no data available to determine the propensity for brexpiprazole to cause NMS; however, due to its mechanistic similarity to aripiprazole, clinicians should continue to monitor their patients for NMS when they are taking brexpiprazole.22
The onset of signs and symptoms usually begins within two weeks of starting therapy with an antipsychotic, and almost all cases of NMS occur within 30 days of the first dose, but NMS can occur after the first dose or after years of taking the same drug at the same dose and can even happen when the use of the drug is discontinued.22,32 If NMS occurs, the use of the antipsychotic drug should be discontinued immediately.29
Temperature Regulation
Antipsychotics have been associated with altered thermoregulation and can have anticholinergic effects, both of which can put the patient at risk for an elevated temperature.2 Dehydration, high ambient temperature, the concurrent use of anticholinergic drugs, and strenuous exercise may increase this risk.2 No specific information has been reported with Rexulti, but this is something that should be monitored with all atypical antipsychotics.
Geriatric Patients and Beers Criteria
US Boxed warnings for brexpiprazole include an increased risk for mortality in elderly patients with dementia-related psychosis.7 The Beers Criteria consider antipsychotics inappropriate for use in patients 65 years old who have dementia, as their use in this population may cause stroke, cognitive decline, and an increase in mortality.2 For the atypical antipsychotics, the Beers Criteria warns that their use in elderly patients who have dementia increases the risk for serious adverse effects, and they should only be used to treat behavioral problems in this patient population when non-pharmacological interventions have not worked, and the patient is a danger to self or to others.33
Suicidal Ideation and Behavior
The prescribing information for brexpiprazole includes a US Boxed Warning that states that antidepressants increase the risk of suicidal behavior and ideation in patients 24 years of age and younger.2,7 Brexpiprazole is not categorized as an antidepressant; however, atypical antipsychotics are often prescribed for patients who have unipolar major depression. Although the FDA data analysis that was the basis for the US Boxed Warning about antidepressants and suicide did not include information about the atypical antipsychotics, the prescribing information for brexpiprazole and the other atypical antipsychotics is required to include the US Boxed Warning about suicide.2
Pregnancy and Breastfeeding
Brexpiprazole has not been assigned a pregnancy category by the Food and Drug Administration, and there are no well-controlled studies examining the risks of taking brexpiprazole during pregnancy.2 The use of atypical antipsychotics during the third trimester has been associated with neonatal EPS and withdrawal signs and symptoms.2,7
There is a national exposure registry that collects information about atypical antipsychotics and pregnancy. There is no published information on the use of brexpiprazole and breastfeeding.34 If a woman chooses to breastfeed while on medication, the infant should be monitored for possible adverse effects of the medication.
National Pregnancy Registry for Atypical Antipsychotics: For information, call 1-866-961-2388 |
Other Warnings and Precautions
Warnings about drug-induced QT prolongation, dysphagia and aspiration, hematologic abnormalities, and elevated prolactin levels are included in the prescribing information for brexpiprazole.2,36
Brexpiprazole Overdose
Atypical antipsychotics are relatively well tolerated, even if a patient overdoses.32,36 Fatalities are rare with atypical antipsychotics, but there is an increased risk of sudden cardiac death.2,28 Atypical antipsychotics usually cause anticholinergic effects, orthostatic hypotension, and sedation.2,28 Although serious cases can present with coma, QTc, and (occasionally) QRS prolongation, seizures, and respiratory depression, these are uncommon.2,7,28,34 The onset of effects usually is within one to two hours after ingestion, and the peak effects occur within six hours.7,28 No published cases of injury from brexpiprazole overdose were located, and the toxic doses of brexpiprazole are not known. Overdose cases have been reported during brexpiprazole studies, but the participants did not suffer any lasting effects from the overdose.22,26
Treatment of brexpiprazole overdose should be symptomatic and supportive; there is no antidote.32,37 Activated charcoal is recommended if its use would be appropriate and safe; gastric lavage should not be used.38 Atypical antipsychotics are highly protein-bound, have a high volume of distribution, and have low blood levels, so extracorporeal removal would be unlikely to be effective.32
If other protocols are not available: Call 911 for emergencies or poison control 800-222 1222 |
Drug Interactions
Brexpiprazole is primarily metabolized by CYP2D6 and CYP3A4. Concurrent use of brexpiprazole and the drugs that have strong effects on CYP3A4 and CYP2D6 may be contraindicated, or concurrent use should be done very cautiously and with dosing adjustment and close monitoring.2
Significant CYP3A4 inducers include phenytoin, rifampicin, St. John’s wort, carbamazepine, and barbiturates, while significant CYP3A4 inhibitors include clarithromycin, ketoconazole, and grapefruit juice.39
While not exhaustive, some significant CYP2D6 inhibitors include diphenhydramine, fluoxetine, haloperidol, and paroxetine. CYP2D6 is less susceptible to induction, so only CYP2D6 inhibitors may require dose adjustments.39
Some CYP inhibitors and inducers do not require dose adjustments for brexpiprazole. These include dextromethorphan (CYP2D6), lovastatin (CYP3A4), bupropion (CYP2D6 and 2B6), fexofenadine (P-gp), and gastric pH modifiers such as omeprazole.2
Studies Reviewing the Uses of Brexpiprazole
As mentioned above, brexpiprazole is approved to treat schizophrenia, as an adjunctive treatment for MDD, and to treat agitation in patients with Alzheimer's Disease. The following sections discuss study findings for these uses.2
Major Depressive Disorder
Atypical antipsychotics are recommended as an adjunctive treatment for the treatment of MDD.2 The FDA approved this indication for brexpiprazole based on results from two phase-3 trials.2,40,41 Patients who were unresponsive to therapy with at least one previous antidepressant were randomized to receive brexpiprazole (3 mg, 213 patients; 2 mg, 175 patients; 1 mg, 211 patients) plus an antidepressant, or an antidepressant plus a placebo (381 patients). After six weeks, the patients who were given 2 mg or 3 mg of brexpiprazole had significant improvement compared to the placebo-treated patients; the patients given 1 mg of brexpiprazole did not.40,41 The most commonly reported adverse effects in both trials were akathisia and weight increases, with some reports of headaches as well.40,41 Subsequent research has confirmed the effectiveness of brexpiprazole as an adjunctive therapy for MDD, but several reviews and meta-analyses have concluded that the evidence is limited and largely derived from a small number of short-term trials.42-44
Brexpiprazole, as adjunctive therapy, can be beneficial in effectively reducing the symptoms of depression.45 There are no studies that have directly compared the effectiveness of brexpiprazole to other atypical antipsychotics as an adjunctive treatment for MDD.44 A review found that there was no difference between aripiprazole, brexpiprazole, cariprazine, olanzapine, or risperidone in their effectiveness as an adjunctive treatment for MDD.43
Schizophrenia
Antipsychotics are the first-choice drug for acute and maintenance treatment of schizophrenia, and the efficacy of brexpiprazole as a treatment for schizophrenia was first established in two phase-3 clinical trials (VECTOR and BEACON trials).46-50 A third clinical trial, the LIGHTHOUSE trial, followed.46,50
In the VECTOR trial, patients who were having an acute exacerbation of psychotic symptoms of schizophrenia were randomized to receive brexpiprazole 0.25 mg, 2 mg, 4 mg, or placebo; 445 patients received brexpiprazole, and 178 received a placebo. After six weeks, the scores of the Positive and Negative Symptom Scale (PANSS) and the Clinical Global Impressions scale (CGI) were compared, and the PANSS and CGI scores for the patients who had taken 2 mg or 4 mg of brexpiprazole were significantly improved compared to the placebo-treated group.47
Further, patients who were having an acute exacerbation of psychotic symptoms of schizophrenia were randomized to receive brexpiprazole 0.25 mg, 2 mg, 4 mg, or placebo; 490 patients received brexpiprazole, and 184 received a placebo.2 After six weeks, the scores of the Positive and Negative Symptom Scale (PANSS) and the Clinical Global Impressions scale (CGI) were compared, and the PANSS and CGI scores for the patients who had taken 4 mg of brexpiprazole were significantly improved compared to the placebo-treated group.2 The PANSS and CGI scores in patients who received 1 mg or 2 mg of brexpiprazole showed numerical improvement compared with the placebo group, but the differences were not clinically significant.48
These trials were limited, but recent reviews suggest that short-term and long-term treatment plans using brexpiprazole may treat the symptoms of schizophrenia throughout the changes and phases that characterize this disorder.50,51
Agitation Associated with Alzheimer's Dementia
For the treatment of agitation associated with Alzheimer's dementia, a patient must have a diagnosis of probable Alzheimer's disease according to NINCDS-ADRDA criteria, have a Mini-Mental State Examination (MMSE) score of ≥5 and ≤22 and have a total score of ≥4 by the agitation/aggression item of the NPI/NPI-NH, and exhibit sufficient agitation behaviors at time of entry to warrant use of pharmacotherapy, after excluding other factors.2,8,9 Starting dose is 0.5 mg/day, with a target dose of 2 mg/day.2 The maximum dose is 3 mg/day.2
Brexpiprazole v. Aripiprazole and Cariprazine
Brexpiprazole and aripiprazole are both dopamine partial agonists.52-54 Brexpiprazole has lower intrinsic activity at D2 receptors than aripiprazole, which may result in fewer activating adverse events. Brexpiprazole is also more potent as a 5-HT1A partial agonist, 5-HT2A antagonist, and É‘1B antagonist than aripiprazole, which may reduce akathisia, EPS, and hyperprolactinemia. Brexpiprazole is a more potent H1 receptor antagonist than aripiprazole, but it has a more than 50-fold lower affinity for H1 receptors relative to D2/5-HT1A receptors, which may limit the risk of weight gain and sedating adverse effects.53 Citrome, et al. (2016) revealed that brexpiprazole (3 mg) had similar efficacy to aripiprazole (15 mg) for treatment in acute schizophrenia, measured by a reduction in PANSS scores; however, brexpiprazole was associated with a lower incidence of akathisia (9.4%) compared to aripiprazole (21.2%), and similar rates of weight gain from baseline to week 6.53
There are a few open-label trials comparing brexpiprazole and aripiprazole. A comparative study between aripiprazole, brexpiprazole, and cariprazine acknowledged the “clinical efficacy of aripiprazole, brexpiprazole, and cariprazine in the treatment of various psychiatric disorders,” but they highlighted the lack of “head-to-head comparisons between them.”55 This is important because “there are clinically meaningful differences in their effects that can be attributed to their specific pharmacological profiles.”55 One study, using Medicare data, found no difference in six-month mortality between new users of brexpiprazole and aripiprazole with diagnosed dementia.56
Ongoing Research
Brexpiprazole is being investigated for the treatment of unipolar and bipolar patients with treatment-resistant depression when used in combination with other drugs.57 A 2022 study reported on a drug treatment that combines brexpiprazole with maintenance esketamine or intravenous ketamine for unipolar and bipolar patients with treatment-resistant depression.57 The authors highlighted a possible connection between a reduction in suicidal behavior and improvements in cognition and patients’ abilities to function.57
Some challenges remain, such as patients experiencing “overlapping adverse events” from the combination of medication, cost, and availability. More research is needed before it can be considered as a treatment option for unipolar and bipolar patients with treatment-resistant depression.57
Summary
Brexpiprazole is an atypical, second-generation antipsychotic with its main mechanism of action as a dopamine partial agonist. It is indicated for the treatment of schizophrenia in adults and in patients ages 13 and older. For patients diagnosed with schizophrenia, the treatment goal is a reduction in positive and negative symptoms, with the patient recognizing that the symptoms may not be eliminated completely. An individualized approach to treatment is necessary for consideration as monotherapy or in combination with add-on therapies, such as valproic acid, mood-stabilizing anticonvulsants, lithium, topiramate, and benzodiazepines.
Brexpiprazole is also approved as an adjunctive therapy for the treatment of major depressive disorder in adults, and for the treatment of agitation associated with Alzheimer's dementia. The treatment goal is a reduction of symptoms associated with major depressive disorder or agitation.
Notable adverse effects include akathisia and weight gain. Data is limited comparing brexpiprazole to other antipsychotics, but it is prescribed as a treatment option in patients who have not tolerated other antipsychotics well.
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