Patient stories
about ZURZUVAE

KATLYN:

I always knew that I wanted to be a mom. I have one son. His name is Cayson. I love the busyness, the—the imagination that he has…

… and just—every day is different.

I experienced some symptoms of depression a few years prior to being pregnant with Cayson.

I did take medication. I stopped medication while I was pregnant. After Cayson was born, I started noticing some symptoms of depression within a few weeks.

I was a single mom and felt so alone. I lost motivation to do the hobbies I used to love, like crafting.

I felt like a failure—like I wasn’t a good enough mom. I stopped taking care of myself—even doing simple things like showering. All I wanted to do was sleep.

I had talked to my OB at my six-week follow-up and kind of let them know how I was feeling. Initially, I didn’t want to tell her, because I thought it was something I had to deal with myself. But at the end of the day, I knew I needed to say something, because I didn’t want to feel like that anymore.

I completed a screener, which meant answering a list of questions about my symptoms. My OB asked me some follow-up questions and, based on my answers, she diagnosed me with postpartum depression, or PPD. She and I decided I should go back on the medication I was on before pregnancy.

My medications weren’t helping as much as I would have liked. I was hoping that there was something else out there to help. It was about eight months after Cayson was born that I had found the clinical trial for women with postpartum depression. I actually heard about the clinical trial scrolling on social media. It was testing an investigational medication…

… which would later be known as ZURZUVAE (zuranolone). I learned more about the trial and took all the steps I needed to enroll. The trial staff told me that I would receive ZURZUVAE or a placebo, which is a fake pill, but I wouldn’t know which one.

They said it was okay for me to continue taking my other medication during the trial. We talked about potential side effects and what to expect. They told me not to drive for at least 12 hours after taking the treatment, since ZURZUVAE may decrease awareness and alertness.

Yeah, I was a little nervous about maybe how the medication could possibly affect me, just being a single mom and being by myself. I decided to join the trial just for that small chance of getting relief from my symptoms of postpartum depression.

Also, with my doctor’s agreement, I had continued taking my other medication for depression throughout the trial.

Treatment with ZURZUVAE was 14 days, but the trial had an observational period that lasted longer.

I started feeling better within three or four days of starting ZURZUVAE. I felt my depression symptoms lifting. My mood started improving. Of course, this is just my experience. Everyone’s experience with ZURZUVAE may be different.

I had a couple of appointments during and after the trial for the nurses and doctors to document how I was doing.

They checked for potential side effects, such as sleepiness, drowsiness, dizziness, common cold, diarrhea, feeling weak, or having no energy, but I don’t remember experiencing any of those.

When my symptoms improved, it felt easier to do more for Cayson, and more for myself. After the 14-day treatment with ZURZUVAE, I felt motivated to get out of the house again—taking Cayson out shopping or going to dinner with friends. I started enjoying old hobbies again. I was grateful to do these things without feeling so weighed down by my PPD symptoms.

After the trial, I received a phone call from the trial staff where they told me that I had received ZURZUVAE, not a placebo. Now, I’m newly married to a wonderful man, and I’m in school for a career I’m passionate about. I have hope for the future. I still dream about having a big family. But for now, I love watching my son grow into his own person.

My advice for moms who may not feel like themselves is to talk to a friend or family member, and to their healthcare team, about how they’re feeling. If their doctor does diagnose them with PPD, they should discuss treatment options to find one that’s right for them.

I want women to know that they’re not alone, and it’s not their fault. A lot of women go through this, and there’s an oral treatment approved for PPD, ZURZUVAE, that may be able to help.

VO:

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ZURZUVAE^®?

ZURZUVAE may cause serious side effects, including:

• Decreased ability to drive or do other dangerous activities. ZURZUVAE may decrease your awareness and alertness, which can affect your ability to drive safely or safely do other dangerous activities.
  • Do not drive, operate machinery, or do other dangerous activities until at least 12 hours after taking each dose during your 14-day treatment course of ZURZUVAE
  • You may not be able to tell on your own if you can drive safely or tell how much ZURZUVAE is affecting you
• Decreased awareness and alertness [central nervous system (CNS) depressant effects]. ZURZUVAE may cause sleepiness, drowsiness, slow thinking, dizziness, confusion, and trouble walking
  • Because of these symptoms, you may be at a higher risk for falls during treatment with ZURZUVAE
  • Taking alcohol, other medicines that cause CNS depressant effects, or opioids while taking ZURZUVAE can make these symptoms worse and may also cause trouble breathing
  • Tell your healthcare provider if you develop any of these symptoms, or if they get worse during treatment with ZURZUVAE. Your healthcare provider may decrease your dose or stop ZURZUVAE treatment if you develop these symptoms

ZURZUVAE is a federally controlled substance (C-IV) because it contains zuranolone, which can be abused or lead to dependence. Keep ZURZUVAE in a safe place to protect it from theft. Do not sell or give away ZURZUVAE, because it may harm others and is against the law.

Before taking ZURZUVAE, 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 liver or kidney problems
• are pregnant or plan to become pregnant. ZURZUVAE may harm your unborn baby
• are breastfeeding or plan to breastfeed. 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 ZURZUVAE

Females who are able to become pregnant:

• Tell your healthcare provider right away if you become pregnant during treatment with ZURZUVAE
• You should use effective birth control (contraception) during treatment with ZURZUVAE and for 1 week after the final dose
• There is a pregnancy registry for females who are exposed to ZURZUVAE during pregnancy. The purpose of the registry is to collect information about the health of females exposed to ZURZUVAE and their baby. If you become pregnant during treatment with ZURZUVAE, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visit online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZURZUVAE and some medicines may interact with each other and cause serious side effects. ZURZUVAE may affect the way other medicines work, and other medicines may affect the way ZURZUVAE works.

Especially tell your healthcare provider if you take antidepressants, opioids, or CNS depressants such as benzodiazepines.

What should I avoid while taking ZURZUVAE?

• Do not drive a car, operate machinery, or do other dangerous activities until at least 12 hours after taking each dose of ZURZUVAE, because ZURZUVAE may make you feel sleepy, confused, or dizzy
• Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking ZURZUVAE without talking to your healthcare provider

See “What is the most important information I should know about ZURZUVAE?”

ZURZUVAE may cause serious side effects, including:

See “What is the most important information I should know about ZURZUVAE?”

• Increased risk of suicidal thoughts or actions. ZURZUVAE and other antidepressant medicines may increase the risk of suicidal thoughts and actions in people 24 years of age and younger. ZURZUVAE is not for use in children

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

The most common side effects of ZURZUVAE include:

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

These are not all of the possible side effects of ZURZUVAE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What is ZURZUVAE?

ZURZUVAE is a prescription medicine used to treat adults with postpartum depression (PPD).

It is not known if ZURZUVAE is safe and effective in children.

Please see full Prescribing Information, including Boxed Warning and Medication Guide.