Clozapine in Florida: Comprehensive Guide for Treatment-Resistant Schizophrenia

Clozapine is the gold-standard antipsychotic for individuals with treatment-resistant schizophrenia (TRS), offering unique benefits such as reduced suicide risk and improved overall mortality. Despite its efficacy, clozapine remains underutilized due to historical safety concerns and complex monitoring requirements. This guide provides Florida residents with essential information on clozapine, including its clinical use, safety updates, and expert discussions.

What Is Clozapine?

Clozapine is an atypical antipsychotic approved by the FDA for:

• Treatment-resistant schizophrenia (TRS)

• Reducing suicidal behavior in schizophrenia and schizoaffective disorder​

TRS is defined by the failure to respond to at least two adequate trials of antipsychotic medications. Approximately one-third of individuals with schizophrenia meet this criterion. Clozapine has demonstrated a response rate of 40–60% in TRS cases, compared to less than 7% with other antipsychotics .​

Clozapine in Florida: Access and Monitoring

As of February 2025, the FDA has rescinded the Risk Evaluation and Mitigation Strategy (REMS) requirement for clozapine, simplifying access for patients and providers . However, prescribers are still advised to monitor patients' absolute neutrophil count (ANC) levels according to the prescribing information .​

Expert Discussions on Clozapine

The Psychiatry & Psychotherapy Podcast, hosted by Dr. David Puder, offers in-depth discussions on clozapine.

• Episode 236: Clozapine & Schizophrenia
  An updated clinical guide on clozapine, covering pharmacology, initiation best practices, side effect management, and emerging uses. Article by Joanie Burns, APRN, and David Puder, MD.

• Episode 049: Clozapine and Schizophrenia
  An earlier discussion highlighting clozapine's unique effects, including its role in reducing suicide and violence in patients. ​

• Episode 190: Schizophrenia Treatment: Clozapine, LAIs
  Explores the history and use of clozapine, addressing its underutilization and the need for effective implementation strategies.

• Episode 129: Managing Treatment-Resistant Psychosis
  Discusses clozapine's impact on reducing suicide risk and all-cause mortality, despite its adverse effect profile.

Side Effects and Management

While clozapine is effective, it carries potential side effects, including:​

• Severe neutropenia

• Constipation (which can lead to bowel obstruction)

• Sialorrhea (excessive salivation)

• Seizures

• Sedation

• Myocarditis

• Tachycardia

• Orthostatic hypotension

• Benign fever

• Cardio-metabolic effects

Management strategies include minimizing other anticholinergic medications, ensuring adequate hydration, and initiating a bowel regimen to address constipation.

Additional Resources

• FDA Information on Clozapine: Provides comprehensive details on clozapine's uses, risks, and monitoring requirements.

If you or a loved one are struggling with treatment-resistant schizophrenia or need specialized care involving clozapine, our experts Joanie Burns, APRN, and David Puder, MD, are here to help.

Reach out today to schedule your consultation and take the next step toward effective, personalized treatment:

📞 Call: (407) 706-5747
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