The Silent Burden of Mental Illness - The Road to Recovery
Schizophrenia

Schizophrenia

Major Depressive Disorder

Major
Depressive Disorder

Alzheimer's Disease

Alzheimer's Disease

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Select Your Dedicated Resource Stream

Direct access to scientific precision for prescribers, and compassionate guidance for caregivers.

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HCP Portal

Healthcare Professionals

Access rigorous clinical pharmacology, clinical trial endpoints, renal/hepatic dosing adjustments, and CYP450 interaction tables.

verified Pivotal Efficacy Trials
verified CYP2D6 & 3A4 Dosimetry
verified Akathisia Incidence Data
verified DCGI Monograph
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Patient & Family

Patients & Caregivers

Supportive guidance on understanding behavioral episodes, daily medication adherence routines, managing agitation, and doctor discussion guides.

check_circle Dementia Agitation Guide
check_circle Behavior Tracking Sheet
check_circle Caregiver Respite Tips
check_circle What to Expect in Week 1-4
Therapeutic Spectrum

Three Distinct Indications. One Measured Balance.

Refer to country-specific regulatory approvals. Indian DCGI approval applies to Schizophrenia; adjunct MDD and AD-related agitation are recognized in US FDA guidelines.

Schizophrenia Therapeutic Focus
DCGI & FDA Approved Monotherapy

Schizophrenia

Acute treatment of exacerbations and maintenance treatment for relapse prevention. Improves positive and negative symptoms while supporting emotional engagement.

Starting Dose: 1 mg / day (Days 1–4)
Target Dose: 2 mg to 4 mg / day
Dosing Protocol for Schizophrenia arrow_forward
Major Depressive Disorder Therapeutic Focus
Adjunctive MDD US FDA Indicated

Major Depressive Disorder

Adjunctive therapy to antidepressants for the treatment of MDD in adults who demonstrate inadequate response to ongoing standard antidepressant monotherapy.

Starting Dose: 0.5 mg or 1 mg / day
Target Dose: 2 mg / day (Max 3 mg)
MDD Adjunctive Evidence arrow_forward
Agitation in Alzheimer's Dementia Therapeutic Focus
Alzheimer's Agitation US FDA Indicated

Agitation in Dementia

Indicated for the treatment of agitation associated with dementia due to Alzheimer's disease. Helps reduce severe physical and verbal aggressive behaviors.

Starting Dose: 0.5 mg / day (Days 1–7)
Target Dose: 2 mg / day (Max 3 mg)
Dementia Agitation Support arrow_forward
Molecular Pharmacology

The Science of Balanced Modulation

Unlike full antagonist antipsychotics that provoke high receptor shutdown and severe EPS, or first-wave partial agonists with higher intrinsic stimulation, Brexpiprazole acts as a fine-tuned neuro-modulator.

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Sub-Maximal D2 Intrinsic Agonism Provides sufficient tone to prevent Parkinsonian tremor while blocking hyperactivity responsible for agitation.
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Superior 5-HT1A Affinity Exceptional sub-nanomolar affinity facilitates serotonin modulation, delivering anxiolytic properties.
Comparative Agonist Profile Spectrum Target Zone: Therapeutic Calmness
Full Agonist (Dopamine Baseline) 100% Intrinsic Stimulation
Early Partial Agonists (Aripiprazole) ~60% - 70% Intrinsic Activity (Akathisia Risk)
check_circle BRESLEY™ (Brexpiprazole) ~43% Intrinsic Activity (Optimal Calmness Zone)

Reduces excessive dopaminergic spikes without triggering motor agitation or complete emotional blunting.

Pure Antagonists (Haloperidol, Risperidone) 0% Intrinsic Activity (Elevated EPS & Hyperprolactinemia)
Precision Dosing Architecture

Six Calibrated Strengths. Zero Tablet Splitting.

Fine micro-titration designed for fragile psychiatric profiles and elderly Alzheimer's patients, avoiding the erratic serum spikes of crushed or split tablets.

Ultra-Low Start
0.25
0.25 mg CYP Poor-Metabolizers
AD Initial Step
0.5
0.5 mg Days 1–7 Titration
Base Step
1.0
1 mg Initial Schiz. Dose
Target Standard
2.0
2 mg Target MDD & AD
High Response
3.0
3 mg Max Dose in AD Agit.
Max Efficacy
4.0
4 mg Target in Schizophrenia

Need Indication-Specific Titration Schedules?

Review full tables for CYP2D6/CYP3A4 co-administration dose adjustments and moderate-to-severe hepatic impairment adjustments.

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Supporting Those Who Support Others

Managing behavioral agitation in Alzheimer's disease or caring for a loved one with schizophrenia is emotionally exhaustive. BRESLEY provides structured observational tools and educational guides to help restore predictability to daily life.

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Agitation Diary

Log triggers, time of day, and physical episodes for your doctor.

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Caregiver Respite

Practical methods to prevent burnout and recognize emotional fatigue.

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Doctor Checklist

Key questions to ask during monthly psychiatric reviews.

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Calming De-Escalation Tip

"When agitation starts to escalate, avoid direct confrontation or arguing about facts. Step into their emotional reality, reduce background noise and light, and redirect gently."

From: BRESLEY Family Guide Read All 12 Strategies →
Medical Affairs & Safety

Clinical Inquiries & Pharmacovigilance

Healthcare practitioners and patients may request medical product literature, off-label inquiry disclaimers, or report adverse reactions directly to our qualified pharmacovigilance cell.

phone_in_talk Toll-Free Safety Line: 1800-BRESLEY
mail safety@bresley-rx.com
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WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS

Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. BRESLEY is not approved for the treatment of patients with dementia-related psychosis without agitation associated with dementia due to Alzheimer's disease.

Suicidal Thoughts and Behaviors: Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and after changes in dosing. BRESLEY is not approved for pediatric patients.

Contraindications & Cerebrovascular Adverse Events expand_more

BRESLEY is contraindicated in patients with a known hypersensitivity to brexpiprazole or any components in the formulation. Reactions have included rash, facial swelling, urticaria, and anaphylaxis.

In placebo-controlled trials in elderly patients with dementia, there was a significantly higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities.

Neuroleptic Malignant Syndrome (NMS) & Tardive Dyskinesia expand_more

A potentially fatal symptom complex known as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs. Clinical manifestations include hyperpyrexia, muscle rigidity, altered mental status, and autonomic instability. Immediately discontinue treatment if NMS is suspected.

The risk of developing tardive dyskinesia (potentially irreversible, involuntary, dyskinetic movements) increases with the duration of treatment and the total cumulative dose.

Metabolic Changes & Pathological Compulsive Behaviors expand_more

Atypical antipsychotics have been associated with metabolic changes including hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain. Regular baseline and periodic blood glucose and lipid assessments are recommended.

Postmarketing reports indicate that patients can experience intense urges, particularly for gambling, binge eating, compulsive shopping, and sexual urges while taking brexpiprazole.

DCGI Reg. No: CL-ND/04/2023 • Schedule H Prescription Drug View Complete Prescribing Information & Medication Guide (PDF)