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Generic name: zuranolone (zuu RAN oh lone)
Brand name: Zurzuvae®
Capsules: 20mg, 25mg, 30mg
All FDA warnings are at the end of this fact sheet. Please consult them before taking this medication.
Zuranolone is an antidepressant medication that works in the brain. It is approved for the treatment of postpartum depression (PPD).
Symptoms of postpartum depression include:
Zuranolone may cause you to feel very sleepy (excessive sedation). It is not recommended to drive a motor vehicle or engage in other potentially hazardous activities like operating machinery until at least 12 hours after the dose was taken. This applies to the full 14 day treatment course.
Based on animal studies, zuranolone may cause fetal harm. Patients who may become pregnant should use effective contraception during treatment and for 1 week after the final dose of taking zuranolone. If you become pregnant during treatment with zuranolone, talk to your health care provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
Let your health care provider know if you are breastfeeding or plan to breastfeed. Zuranolone passes into breast milk at low levels. Talk to your health care provider about the risks and benefits of breastfeeding and about the best way to feed your baby while receiving zuranolone.
Zuranolone is usually taken once daily in the evening with fat-containing food (400 to 1,000 calories). It is typically taken for 14 days. The usual dose is 50 mg daily but may be reduced to 40 mg daily in the evening based on tolerability.
Zuranolone may be given alone or in addition to another oral antidepressant.
Zuranolone may make you feel dizzy and sleepy. Do not drive a car or do other activities that require mental alertness for at least 12 hours after taken a dose.
Do not drink alcohol. Drinking alcohol while receiving zuranolone can increase the risk of excess sleepiness.
Postpartum depression and certain other psychiatric disorders are themselves associated with the risk of suicide. Women with postpartum depression, may experience worsening of their depression and/or emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications. This risk may persist until significant remission occurs. Zuranolone and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger. All patients being treated with antidepressants for any indication should watch for and notify their health care provider for worsening symptoms, suicidality and unusual changes in behavior, during treatment.
There is a risk of physical and/or emotional dependence (addiction). Talk to your provider about the risk.
Central nervous system depressants, such as benzodiazepines, opioids, or tricyclic antidepressants, may enhance the feeling of sedation when taken with zuranolone.
In clinical studies, zuranolone caused sleepiness and confusion in a dose dependent way. This risk can be even higher if taking another central nervous system depressant (like alcohol, opioids, benzodiazepines) at the same time. Patients taking zuranolone should let their health care providers know about any other medications they may be taking at the same time.
Due to the higher risk of sleepiness and confusion, people taking zuranolone may be at higher risk of falls and dizziness. This sometimes required changing the dose for certain individuals in the clinical studies. If patients experience sleepiness, confusion, falls or dizziness while taking zuranolone, they should talk to their health care provider.
The level of sleepiness due to zuranolone also caused impaired driving ability in two driving simulation studies. Patients taking zuranolone should avoid driving, operating machinery or other potentially dangerous activities that require mental alertness for at least 12 hours after each zuranolone dose.
©2023 The American Association of Psychiatric Pharmacists (AAPP) and the National Alliance on Mental Illness (NAMI). AAPP and NAMI make this document available under the Creative Commons Attribution-NoDerivatives 4.0 International License. Last Updated: January 2016.