Zurzuvae
Pronunciation: zur-ZOO-vay
Generic name: zuranolone
Dosage form: capsules (20 mg, 25 mg, 30 mg)
Drug class: Miscellaneous antidepressants
What is Zurzuvae?
Zurzuvae (zuranolone) is a once-daily capsule for postpartum depression (PPD) that rapidly starts to improve symptoms in 3 days. Zurzuvae capsules are taken once daily in the evening for 14 days, with foods that contain fat.
Zurzuvae improves postpartum depression by acting on GABAA receptors. GABA is a chemical messenger (neurotransmitter) that helps to regulate mood. Zurzuvae is from the class of medicines called positive allosteric modulator.
Zurzuvae FDA approval was granted on August 04, 2023, to treat adults with postpartum depression. It is a Schedule IV controlled substance.
How effective is Zurzuvae?
The clinical trial NCT04442503 evaluated the effectiveness of Zurzuvae 50mg for treating postpartum depression in adults.
The study found that women who took Zurzuvae 50mg daily for 2 weeks experienced a statistically significant reduction in depressive symptoms by day 15. The symptoms were measured using the 17-item Hamilton Rating Scale for Depression (HAMD-17).
- Zurzuvae 50mg reduced the depression score by −15.6 (HAMD-17) compared to the placebo score, which decreased by −11.6, a difference of -4.0.
- Symptoms of depression improved from day 3 and lasted through to day 42.
What is Postpartum depression?
Postpartum depression is a major depressive episode that can occur after childbirth, but can also start during the later stages of pregnancy. PPD is a serious condition in which women may feel intense anxiety, sadness, shame, guilt, problems sleeping, stress, panic attacks, and suicidal thoughts or attempts. This can make it difficult for mothers to care for and bond with their babies and may delay the child's physical and emotional development.
Zurzuvae Side Effects
Common Zurzuvae side effects may include:
- feeling weak or tired, drowsiness;
- dizziness;
- pain and burning when you urinate;
- diarrhea; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
Zurzuvae may cause serious side effects, including:
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Increased risk of suicidal thoughts or actions. Zurzuvae, along with other antidepressant medicines, may increase the risk of suicidal thoughts and actions in people that are 24 years of age and younger. This medicine is not for use in children. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
It is important to watch for and try to prevent suicidal thoughts and actions.
- Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.
- Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
Tell your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: attempts to commit suicide, panic attacks, thoughts about suicide or dying, new or worse irritability, new or worse depression, acting aggressive or being angry or violent, feeling very agitated or restless, an extreme increase in activity and talking, trouble sleeping, acting on dangerous impulses, new or worse anxiety, other unusual changes in behavior or mood.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Warnings
Zurzuvae can make you very drowsy. Tell your caregivers if you feel light-headed or feel like you cannot stay awake. Avoid driving or hazardous activity for at least 12 hours after taking zuranolone. Your reactions could be impaired.
People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.
Before taking this medicine
Tell your healthcare provider about all of your medical conditions, including if you:
- drink alcohol
- have abused or been dependent on prescription medicines, street drugs, or alcohol
- have kidney or liver problems.
Pregnancy
Tell your health care provider if you are pregnant or plan to become pregnant, as this medicine may harm your unborn baby.
If you are able to become pregnant, use effective birth control while using Zurzuvae and for at least 1 week after your last dose. Tell your doctor if you become pregnant or plan to become pregnant.
You should tell your healthcare provider right away if you become pregnant while on Zurzuvae.
Use effective birth control while using zuranolone and for at least 1 week after your last dose. Tell your doctor if you become pregnant or plan to become pregnant.
Breastfeeding
Zurzuvae passes into breast milk, and it is not known if it can harm your baby. Talk to your healthcare provider about the risks and benefits of breastfeeding and about the best way to feed your baby during treatment with this.
Dosing information
Zurzuvae is taken once a day in the evening, with fatty food, for 14 days (two weeks). Take with fat-containing food (e.g., 400 to 1000 calories, 25 to 50% fat)
Dose: 50 mg evening.
Duration: 14 days.
Comments: Patients unable to tolerate 50 mg once daily may have dose reduced to 40 mg.
This medicine can be used as a single therapy or together with other oral antidepressant medications.
Zurzuvae is available as 20mg, 25mg and 30mg capsules.
What happens if I miss a dose?
If you forget to take your capsule, skip the missed dose and take the next dose at your regular time the next evening. Do not take extra capsules to make up for the missed dose. Continue taking Zurzuvae once daily until you complete the rest of your treatment course.
What happens if I overdose?
If you take too much Zurzuvae, call your healthcare provider or Poison Help Line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
What to avoid
You should not drive a car, operate machinery, or do other dangerous activities until at least 12 hours after taking each dose of this medicine, as Zurzuvae may make you feel sleepy, confused, or dizzy.
You should not drink alcohol or take other medicines that make you sleepy or dizzy while taking this medicine without talking to your healthcare provider.
What other drugs will affect Zurzuvae?
Many drugs can interact with Zurzuvae. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.
It is especially important to tell your healthcare provider if you take:
- antidepressants
- opioids
- CNS depressants such as benzodiazepines.
Zurzuvae Package Insert
HCPs and patients often use the Zurzuvae Package Insert (PI) for more detailed information about this medicine. The Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not replace the need to discuss your treatment with your doctor.
The Package Insert is sometimes called the Zurzuvae Prescribing Information (PI) or FDA label.
Ingredients
Active ingredient: zuranolone
Inactive ingredients: Capsules contain colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate.
The capsule shells contain gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac glaze.
Storage
- Store at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep this medicine and all medicines out of the reach of children.
Company information
Manufactured for: Biogen Inc., 225 Binney Street, Cambridge, MA 02142
Registered trademark: Zurzuvae is a registered trademark of Sage Therapeutics, Inc.
Popular FAQ
How quickly does Zurzuvae (zuranolone) work for PPD?
Zurzuvae significantly improved symptoms of postpartum depression (PPD) as early as the 3rd day after starting treatment and effects were sustained through day 45, based on the SKYLARK Phase 3, placebo-controlled study.
Should I take Zurzuvae (zuranolone) with food?
Yes, take Zurzuvae capsule by mouth once daily in the evening with a fat-containing food for 14 days, the length of the treatment course. Talk to your healthcare provider about which types of high-fat foods you should eat.
Is sleepiness a side effect of taking Zurzuvae (zuranolone)?
Yes, in studies over one-third of people taking a Zurzuvae 50 mg dose experienced sleepiness. Take your dose in the evening so that it does not interfere with daily activities. Also avoid driving, operating machinery or other dangerous activities for 12 hours after a dose.
Is it safe to use Zurzuvae (zuranolone) beyond 14 days?
It is not known if it is safe to continue using Zurzuvae after the 14 day single treatment course. Take Zurzuvae exactly as your healthcare provider tells you to take it.
How does Zurzuvae differ from traditional antidepressants?
Zurzuvae differs from traditional antidepressants as it is the first oral treatment approved for postpartum depression (PPD), but it’s not yet approved for major depressive disorder (MDD). It’s only taken for 14 days and it’s a faster-acting antidepressant, with symptom improvement starting as early as the third day. Continue reading
References
- Effect of Zuranolone vs Placebo in Postpartum Depression
- Food and Drug Administration (FDA) Zurzuvae Product Label
- Biogen and Sage Therapeutics Announce FDA Accepts Filing of New Drug Application and Grants Priority Review of Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression
- FDA Approves First Oral Treatment for Postpartum Depression
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