Zuranolone Dosage

Medically reviewed by Drugs.com. Last updated on Dec 5, 2023.

Usual Adult Dose for Postpartum Depression

Recommended dose: 50 mg orally once a day in the evening
Duration of therapy: 14 days

Comments:

• Administer with fat-containing food (e.g., 400 to 1000 calories, 25 to 50% fat)

Use: For the treatment of postpartum depression

Renal Dose Adjustments

• Mild renal impairment (eGFR 60 to 89 mL/min/1.73 m2): No adjustment recommended
• Moderate or severe renal impairment (eGFR less than 60 mL/min/1.73 m2): 30 mg orally once a day in the evening for 14 days

Liver Dose Adjustments

• Mild to moderate liver dysfunction (Child-Pugh A and B): No adjustment recommended
• Severe liver dysfunction (Child-Pugh C): 30 mg orally once a day in the evening for 14 days

Dose Adjustments

Dose Modifications for Concomitant Use with CYP450 3A4 Inhibitors and Inducers:

• CYP450 3A4 Inducers: Avoid concomitant use
• Strong CYP450 3A4 Inhibitors: 30 mg orally once a day in the evening for 14 days when used concomitantly
• Moderate CYP450 3A4 Inhibitors: No adjustment recommended

Central Nervous System (CNS) depressant effects within the 14-day period:

• Consider reducing the dosage to 40 mg once a day in the evening within the 14-day period.

Precautions

US BOXED WARNING:

• IMPAIRED ABILITY TO DRIVE OR ENGAGE IN OTHER POTENTIALLY HAZARDOUS ACTIVITIES: This drug causes driving impairment due to central nervous system (CNS) depressant effects; advise patients not to drive or engage in other potentially hazardous activities until at least 12 hours after administration of this drug for the duration of the 14-day treatment course. Inform patients that they may not be able to assess their own driving competence, or the degree of driving impairment caused by this drug.

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Pending

Dialysis

Data not available

Other Comments

Administration advice:

• This drug can be administered alone or as an adjunct to oral antidepressant therapy.
• Safety and effectiveness of use beyond 14 days in a single treatment course have not been established.
• If a dose is missed, the next dose should be taken at regular time the following evening; extra medication should not be taken to make up for a missed dose. Advise the patient to continue the once-daily schedule until the remainder of the 14-day treatment course is completed.

Storage requirements:

• Store at room temperature 20C to 25C (68F to 77F); excursions permitted between 15C to 30C (59F to 86F)

General:

• This drug has a dose-dependent abuse potential with associated risks of misuse and substance use disorder, including addiction. Abuse-related adverse reactions included euphoric mood, feeling drunk, and somnolence. Individuals with a history of drug abuse or substance use disorders may be at a higher risk. Healthcare providers should assess and discuss these risks with patients.
• This drug may cause physical dependence; adverse reactions reported upon discontinuation included insomnia, palpitations, decreased appetite, nightmares, nausea, hyperhidrosis, and paranoia. Healthcare providers should assess and discuss this with patients.

Patient advice:

• Read the US FDA-approved patient labeling (Package Information and Instructions for Use).
• This drug will impair your ability to drive or engage in hazardous activities. Take this drug in the evening and do not perform any activity that requires alertness after.
• Dizziness, sedation, and confusion have been reported with this drug. Do not take this drug with alcohol or any other medication.
• Contact your healthcare provider immediately if you experience thoughts of suicide.
• Take this medication with fat-containing foods and take the next scheduled dose if you miss a dose.
• This drug has the potential for abuse, misuse, and dependence; do not take more than advised by your healthcare provider.
• Patients of childbearing potential should use highly effective contraception during therapy and for 1 week after the last dose; notify your healthcare provider if you become pregnant.
• Pregnant patients should discuss with their healthcare provider about the risk to the fetus and registering at the pregnancy exposure registry that monitors outcomes while on this drug.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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