What are the newest psychotropic medications on the market for a general adult population with various psychiatric conditions?

Newest Psychotropic Medications on the Market

Most Recent FDA-Approved Psychotropic Medications

Brexpiprazole represents one of the newest atypical antipsychotics approved for major depressive disorder (adjunctive therapy) and schizophrenia, with initial FDA approval in 2015 and recent label updates in 2024. 1

Brexpiprazole (FDA-Approved 2015, Updated 2024)

For major depressive disorder (MDD) as adjunctive therapy to antidepressants:

• Starting dosage: 0.5-1 mg/day orally 1
• Target dosage: 2 mg/day 1
• Maximum dosage: 3 mg/day 1
• Administered once daily with or without food 1

For schizophrenia:

• Starting dosage: 1 mg/day 1
• Target dosage: 2-4 mg/day 1
• Maximum dosage: 4 mg/day 1

Critical dosage adjustments required:

• Patients with moderate to severe hepatic impairment: maximum 2 mg/day for MDD, 3 mg/day for schizophrenia 1
• Patients with CrCl <60 mL/minute: maximum 2 mg/day for MDD, 3 mg/day for schizophrenia 1
• Patients taking strong CYP2D6 or CYP3A4 inhibitors: administer half of recommended dosage 1
• Patients taking both strong/moderate CYP2D6 and CYP3A4 inhibitors: administer one-quarter of recommended dosage 1
• Known CYP2D6 poor metabolizers taking strong/moderate CYP3A4 inhibitors: administer one-quarter of recommended dosage 1

Most Common Adverse Reactions with Brexpiprazole

In MDD patients: weight gain, somnolence, and akathisia occurred in ≥5% of patients at rates at least twice that of placebo 1

In schizophrenia patients: weight gain occurred in ≥4% of patients at rates at least twice that of placebo 1

Critical Safety Warnings for Brexpiprazole

Black box warnings include:

• Increased mortality in elderly patients with dementia-related psychosis (brexpiprazole is NOT approved for this indication) 1
• Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients when used as adjunctive antidepressant therapy 1
• Safety and effectiveness have NOT been established in pediatric patients with MDD 1

Additional serious warnings:

• Cerebrovascular adverse reactions (stroke, TIA) in elderly patients with dementia-related psychosis 1
• Neuroleptic malignant syndrome requiring immediate discontinuation 1
• Tardive dyskinesia requiring consideration of discontinuation 1
• Metabolic changes including hyperglycemia/diabetes, dyslipidemia, and weight gain requiring monitoring 1
• Pathological gambling and other compulsive behaviors requiring dose reduction or discontinuation 1
• Leukopenia, neutropenia, and agranulocytosis requiring CBC monitoring in high-risk patients 1
• Orthostatic hypotension and syncope requiring blood pressure monitoring 1
• Seizures requiring caution in susceptible patients 1
• Cognitive and motor impairment requiring caution with machinery operation 1

Recent FDA Approvals (2018-2023)

Between 2018 and 2022, the FDA approved 12 novel psychiatric medications, representing a very small percentage of total FDA approvals during that period. 2

These medications include agents with novel mechanisms of action or improved efficacy and safety profiles designed to address treatment-resistant populations. 2

As of August 2022 and June 2023, additional psychotropic medications received FDA approval that may provide innovative advances in psychopharmacotherapy. 3, 4

Clinical Context for Newer Medications

Approximately 50% of patients treated with antidepressants show inadequate response, and approximately one-third of schizophrenia patients demonstrate treatment-refractory illness. 2

This high rate of treatment resistance creates pressing need for medications with novel mechanisms of action or new indications, particularly for patients who are fully or partially refractory to first-line options. 2

Broader Spectrum Psychotropic Medications

Quetiapine has emerged as a broad-spectrum psychotropic medication with efficacy across multiple diagnostic categories beyond schizophrenia. 5

Quetiapine demonstrates clinical utility in:

• Mood and anxiety disorders 5
• Obsessive-compulsive disorder 5
• Aggression and hostility 5
• Posttraumatic stress disorder 5
• Borderline personality disorder 5
• Delirium 5
• Comorbid substance abuse 5

Quetiapine's low affinity and fast dissociation from postsynaptic dopamine-2 receptors confer the lowest risk of acute extrapyramidal side effects, tardive dyskinesia, and neuroleptic malignant syndrome among antipsychotics. 5

Critical Considerations When Prescribing Newer Psychotropics

Drug-drug interactions between psychotropic medications require careful evaluation before prescribing, particularly since 70% of antidepressants and 90% of anxiolytics are prescribed by non-psychiatric physicians. 6

Patients frequently receive concurrent medical medications for somatic conditions, necessitating thorough interaction screening before initiating psychotropic therapy. 6