Zuranolone: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
Zuranolone: clinical details
Prescribing considerations
- Initiate under specialist supervision.
- Review renal and hepatic function, pregnancy status, contraception, interacting medicines and concurrent CNS depressants.
- Assess baseline suicidality, substance-use history and the practical implications of sedation for driving, childcare and other safety-critical activities.
- Safety and efficacy have not been established in people younger than 18 years.
- Zuranolone is subject to additional safety monitoring; report suspected adverse reactions through the Yellow Card Scheme.
Contraindications and cautions
- Hypersensitivity to zuranolone or any excipient
- Pregnancy
Monitoring
- Clinical worsening, suicidal thoughts, self-harm risk and unusual behavioural changes
- Somnolence, sedation, dizziness, confusion and functional impairment
- Adherence to driving restrictions and avoidance of alcohol or other CNS depressants
- Pregnancy status and effective contraception where relevant
- Renal and hepatic function where impairment is known or suspected
Clinical pharmacology
Zuranolone is an orally bioavailable synthetic neuroactive steroid and positive allosteric modulator of synaptic and extrasynaptic GABA-A receptors. It is highly protein-bound, primarily metabolised by CYP3A and has an adult terminal half-life of approximately 20 to 25 hours.
Formulation and product differences
- Available as gelatin hard capsules in three strengths, differentiated by capsule colour and printed markings.
- Bottle presentations exist for all strengths; blister presentations are listed for the two lower strengths. Not all pack sizes may be marketed.
- The capsules contain mannitol and are essentially sodium-free.
Zuranolone preparations and strengths
Capsule
Route: Oral
Strengths: 20 mg, 25 mg, 30 mg
Zuranolone interactions
Check all prescribed, non-prescribed and herbal products before treatment.
Alcohol
May increase drowsiness, sedation and impairment of coordination or judgement.
Opioids, benzodiazepines, sleeping tablets, gabapentin, pregabalin and sedating antidepressants
Additive central nervous system depression may worsen sleepiness and psychomotor impairment.
Strong CYP3A inhibitors, including itraconazole, ketoconazole, clarithromycin and ritonavir
Can increase zuranolone exposure and adverse effects, requiring specialist review.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.