Brexanolone Side Effects
Brexanolone's most critical side effects are sudden loss of consciousness and excessive sedation, requiring continuous pulse oximetry monitoring during the entire 60-hour infusion, with additional common effects including dizziness, dry mouth, headache, and flushing. 1, 2
Serious Adverse Effects Requiring Monitoring
- Loss of consciousness, presyncope, or syncope occurs in approximately 4% of patients, representing the most severe safety concern 1
- Excessive sedation and somnolence are frequent enough to mandate continuous pulse oximetry throughout the infusion 2, 3
- Due to these risks, brexanolone is only available through a Risk Evaluation and Mitigation Strategies (REMS) program, requiring administration in a supervised medical setting with continuous monitoring 1, 4
Common Adverse Effects
The most frequently reported side effects during clinical trials include:
- Sedation - among the most common adverse events 1, 2
- Dizziness - frequently reported across studies 1, 2
- Dry mouth - common tolerability issue 2
- Headache - frequently observed 1, 2
- Flushing - noted in clinical trials 2
- Somnolence - related to the drug's GABAergic mechanism 1
Clinical Management Considerations
- Continuous pulse oximetry is mandatory throughout the entire 60-hour infusion period due to risks of sudden loss of consciousness and excessive sedation 2
- Administration must occur in a certified healthcare facility with appropriate monitoring capabilities 4
- The drug has an acceptable overall safety profile when administered with proper monitoring, with most adverse effects being manageable 2, 5
Tolerability Profile
- Brexanolone was generally well-tolerated in all three pivotal clinical trials when administered with appropriate monitoring 2, 5
- The adverse effects are primarily related to its mechanism as a positive allosteric modulator of GABAA receptors, enhancing inhibitory neurotransmission 3, 5
- No serious adverse effects related to transmission of infectious agents or anaphylaxis have been reported, unlike some other intravenous therapies 2