Zuranolone

Zuranolone is a prescription medication used for the treatment of postpartum depression.

• Zuranolone is available under the following different brand names: Zurzuvae

Common side effects of Zuranolone include:

• sleepiness or drowsiness
• diarrhea
• dizziness
• feeling tired, weak, or having no energy
• common cold 
• urinary tract infection

Serious side effects of Zuranolone include:

• increased risk of suicidal thoughts or actions
• attempts to commit suicide
• panic attacks
• thoughts about suicide or dying
• new or worse irritability
• new or worse depression
• acting aggressive, being angry, or violent
• feeling very agitated or restless
• an extreme increase in activity and talking (mania)
• trouble sleeping (insomnia)
• acting on dangerous impulses
• new or worse anxiety
• other unusual changes in behavior or mood

Rare side effects of Zuranolone include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 20 mg
• 25 mg
• 30 mg

Postpartum depression

Adult dosage

• 50 mg orally every evening for 14 days; administer with fat-containing food
• Consider reducing the dose to 40 mg if CNS depressant effects occur within the 14-day treatment period
• May use alone or as an adjunct to oral antidepressant therapy
• Use beyond 14 days in a single treatment course has not been established

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Zuranolone has severe interactions with no other drugs
• Zuranolone has serious interactions with no other drugs
• Zuranolone has moderate interactions with no other drugs
• Zuranolone has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Zuranolone?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Zuranolone?”

Cautions

• Causes driving impairment due to CNS depressant effects
• May cause fetal harm when administered to pregnant women’s
• CNS depressant effects
  • CNS depressant effects reported (e.g., somnolence, confusion)
  • Patients may be at higher risk of falls
  • Other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) or drugs that increase Zuranolone concentration, may increase the impairment of psychomotor performance or CNS depressant effects such as somnolence, cognitive impairment, and the risk of respiratory depression
  • Reduce the risk of CNS depressant effects and/or mitigate CNS depression
  • If CNS depressant effects develop, consider dosage reduction or discontinuation
  • If use with another CNS depressant is unavoidable, consider dosage reduction
• Reduce dosage in patients taking strong CYP3A4 inhibitors
• Suicidal thoughts and behavior
  • In pooled analyses of placebo-controlled trials of long-term administration of antidepressant drugs (SSRIs and other antidepressants), the incidence of suicidal thoughts and behaviors in antidepressant-treated patients aged younger than 24 years was greater than in placebo-treated patients
  • Zuranolone does not directly affect monoaminergic systems; because of this and the comparatively low number of exposures to zuranolone, the risk of developing suicidal thoughts and behaviors is unknown
  • Consider changing the therapeutic regimen, including discontinuing zuranolone, in patients whose depression becomes worse or who experience emergent suicidal thoughts and behaviors
• Drug interaction overview
• CNS depressants
  • Avoid or modify the dose
  • Coadministration with CNS depressants (e.g., alcohol, opioids, benzodiazepines) may have additive pharmacological effects and increase the impairment of psychomotor performance or CNS depressant effects
  • If unavoidable, consider reducing the zuranolone dose
• CYP3A4 inducers
  • Avoid
  • CYP3A4 inducers decrease zuranolone systemic exposure, which may reduce efficacy
• Strong CYP3A4 inhibitors
  • Modify (reduce) zuranolone dose
  • Strong CYP3A4 inhibitors increase zuranolone systemic exposure, which may increase adverse effects

Pregnancy and Lactation

• Based on findings from animal studies, zuranolone may cause fetal harm
• Advise pregnant women of potential risk to a fetus
• Pregnancy exposure registry
• Registry monitors pregnancy outcomes in women exposed to antidepressants during pregnancy
• Clinicians are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online
• Contraception
  • Advise women patients of reproductive potential to use effective contraception during treatment and for 1 week after the final dose
• Lactation
  • Available data from a clinical lactation study in 14 women indicate that zuranolone is present in low levels in human milk
  • There are no data on the effects of zuranolone on breastfed infants and limited data regarding the effects on milk production