Talk to your healthcare provider
about ZURZUVAE

JUNE:

When my son Evan was born, I felt amazing…

… and I felt like I was a superhero—just capable of anything.

I was really excited to be a mom, but I was also scared, ’cause he needed to go to the NICU. I wanted to be helpful, but I found myself not even wanting to go see him, not feeling like I could tolerate being there.

I—I held a lot of—of guilt and anger towards myself around that. I couldn’t enjoy even going outside. I’d see someone pushing a stroller and not have my own baby with me, and it seemed like that wasn’t going to be my future at the time.

When Evan came home from the NICU, I was still struggling a lot. There were plenty of times that I felt like my son and my husband didn’t need me. Why was I even there? I’d had depression…

… and anxiety before, and with my doctor’s approval, continued taking medication for it during and after my pregnancy, but these symptoms felt different.

I decided to see my OB, Dr. Sandelin, about four weeks after Evan was born. Dr. Sandelin always made it a point to talk about the risk of postpartum depression. He had a questionnaire that he would have me fill out at every appointment.

DR. SANDELIN:

In June’s case, her answers showed she was feeling overly tired…

… kind of a lack of interest, both in normal aspects of her life and also in the baby, which also caused her a lot of guilt.

She also was overeating and just felt down.

JUNE:

After my conversations with Dr. Sandelin, where we talked about my answers, he felt confident in diagnosing me with postpartum depression. I was disappointed. I wasn’t ready for another label. I was worried about another long-term treatment. That’s when we talked about ZURZUVAE (zuranolone).

DR. SANDELIN:

In my experience, I find ZURZUVAE to be a good first choice for a lot of patients. It is the first and only FDA-approved oral treatment for adults with postpartum depression. It’s a prescription medicine, taken once a day in the evening with fat-containing food for 14 days.

I told June what I tell many of my patients: that based on the results of a clinical study, her symptoms may start to improve as early as the third day of treatment, and that she could maintain symptom improvement 45 days post-treatment.

JUNE:

The option to have a 14-day treatment was a bit of a relief. I didn’t know that a medication like this existed. I, of course, had questions. I first was concerned about side effects.

DR. SANDELIN:

We talked about the most common side effects of ZURZUVAE…

… which include sleepiness or drowsiness, dizziness, common cold, diarrhea, feeling tired, weak, or having no energy, and urinary tract infection.

I told her not to drive or operate dangerous machinery until at least 12 hours after each dose of ZURZUVAE, and that she might not be able to tell on her own how ZURZUVAE is affecting her.

I also advised June to use effective contraception during treatment with ZURZUVAE, and for one week after the final dose.

I also said to call me right away if she experienced serious side effects like decreased awareness and alertness, difficulty walking, thinking, or concentrating, or thoughts of suicide.

JUNE:

I also was worried about how I might need to adjust how I feed Evan while taking that treatment.

DR. SANDELIN:

June and I talked about the ways to feed her baby if she decided to take ZURZUVAE. We talked about a clinical study that showed there were low levels of ZURZUVAE in breast milk, and that the Prescribing Information does not have data on the effect of ZURZUVAE on infants who are breastfed.

JUNE:

Dr. Sandelin is great about always answering my questions.

He seemed very educated about ZURZUVAE, and the studies, and helped me make a good decision about feeding Evan. I had been supplementing with formula at the time, and so I felt confident, for me, that continuing with formula while I was taking ZURZUVAE was a good plan.

I talked with my family about it, and decided to try ZURZUVAE to treat my PPD symptoms.

I started feeling an improvement in my PPD symptoms around the third or fourth day of taking ZURZUVAE. After weeks of feeling hopeless and exhausted, to wake up and feel more like myself, it was very motivating. Very exciting. By the end of those 14 days, I started to be more of the mom I wanted to be.

I did experience some nausea and drowsiness during treatment. This is my experience, but everyone’s experience with ZURZUVAE may be different.

DR. SANDELIN:

I try to de-stigmatize postpartum depression for my patients because I want them to be open and honest. And I start talking about it even as early as 28 weeks during the pregnancy to let them know that, “Hey, we are gonna talk about this at each of your follow-up visits.” If they’re comfortable being open with me, we can work together to figure out how to help them.

JUNE:

I was so glad that I talked to Dr. Sandelin when I did. Knowing that I had someone that I could trust who was on my side—it really meant a lot to me. I tell other women I know to be aware of the potential symptoms of PPD and talk to their healthcare provider as soon as possible if they start to experience symptoms or have any questions. I’m really glad that I took ZURZUVAE. It was the right choice for me to make with my doctor.

Now that my PPD symptoms have improved, I am loving being a parent to a rambunctious, chaotic little boy. I love watching Evan just become his own person and show new emotions. I love watching him explore, learn new things, climb, get into trouble. I wouldn’t change a thing now, enjoying every—every little moment that happens.

VO:

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ZURZUVAE® (zuranolone)?

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 1-844-405-61851-844-405-6185 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-10881-800-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.