Zulresso (brexanolone) IV Infusion

Postpartum Depression

Postpartum depression (PPD) is a distinct and readily identified major depressive disorder that is the most common medical complication of childbirth, affecting a subset of women typically commencing in the third trimester of pregnancy or within four weeks after giving birth. PPD may have devastating consequences for a woman and for her family, which may include significant functional impairment, depressed mood and/or loss of interest in her newborn, and associated symptoms of depression such as loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy and poor self-esteem. Suicide is the leading cause of maternal death following childbirth. Postpartum depression affects approximately one in nine women who have given birth in the U.S. and 400,000 women annually. More than half of these cases may go undiagnosed without proper medical screening.

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Postpartum depression may be caused by several factors including:

  • Increased levels of stress hormones
  • Poor response to stress
  • Changes in hormone levels
  • Inadequate neurosteroid levels
  • Genetic risk factors
  • Neurocircuit dysfunction
  • History of abuse
  • Lack of support
  • Poor or irregular diet
  • Changes in social or professional life
  • Poor or irregular sleep schedule
  • Isolation and poor support

Symptoms of postpartum depression can include:

  • Exhaustion
  • Anxiety
  • Severe mood swings
  • Feeling like you’re a “bad mother”
  • Trouble sleeping or eating
  • Fears about hurting yourself or others
  • Suicidal thoughts or behaviors
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Zulresso (brexanolone) Intravenous infusion for postpartum depression

zulressoPostpartum depression is a serious illness with major consequences for mothers and their families. It’s very important to recognize and address postpartum depression as quickly as possible after diagnosis. In the past, options took weeks to work and new moms struggled for months without treatment or symptom relief. We now have a very effective medication for postpartum depression, and it works in a matter of hours. It’s an IV infusion medication called Zulresso, and we are one of the few doctors offering this effective treatment to patients.

What is Zulresso? Zulresso is a brand-name prescription medication that’s prescribed for postpartum depression (PPD) in adults. PPD is a type of depression that is associated with pregnancy and made worse by the hormonal fluctuations occurring following delivery. Having a history of depression or anxiety before becoming pregnant as well as depression in the second or third trimester are risk factors for postpartum depression. To be diagnosed with a postpartum mood disorder, symptoms are identified within weeks of giving birth and up to a year postpartum.  Zulresso does not cure PPD, but it can quickly help relieve PPD symptoms. These can include feeling extremely sad, anxious, and overwhelmed. It’s more severe than the “baby blues” many women have shortly after delivery. Untreated PPD can make a mother less able to care for her baby.

Interested in Treatment? Follow links below to get started.

What to Expect with Treatment

Zulresso contains the drug brexanolone. It’s given as an intravenous (IV) infusion, which goes into your vein. Patients receive the infusion over a period of 60 hours (2.5 days). During this time, patients are cared for at Balance Women’s Health’s infusion center. This allows our doctors and nurses to safely provide the treatment while monitoring patients for side effects.

Patients follow a normal schedule for eating and sleeping during treatment. Patients can also spend time with visitors, including their infant (or children), but a family member is responsible for their care as patients will be receiving treatment and may not be able. Patients typically start treatment on Friday morning, and may be discharged to go home on Sunday evening or Monday morning.

Zulresso is only available at a REMS-certified facility. REMS (Risk Evaluation and Mitigation Strategies Trusted Source) is a program created by the Food and Drug Administration (FDA). It helps make sure that drugs are used safely and provided by specially trained healthcare professionals. Balance Women’s Health is a REMS-certified facility.

Zulresso can cause serious side effects, such as severe sedation. Symptoms can include extreme sleepiness, trouble thinking clearly, and not being able to drive or use heavy machinery. Because of how severe these side effects can be, Zulresso is only given in certain healthcare facilities. These facilities have doctors who are specially trained to monitor and treat the possible side effects of Zulresso. This helps make sure you receive Zulresso safely.

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Safety and Efficacy of Zulresso

Clinical trials of Zulresso showed statistically significant reductions in observed depressive symptoms compared to placebo in women with postpartum depression. The treatment was well tolerated with a rapid onset of statistically significant effect from day 3 through two weeks and maintained for four weeks after treatment.

Beginning at day 3, 45% of women had REMISSION of their symptoms and 72% of women had RESPONDED (with at least a 50% reduction in symptoms). By the end of the study, 53% of patients achieved REMISSION from their symptoms and 75% had RESPONDED (with at least a 50% reduction in symptoms). This is a very high rate of response when compared with other pharmacotherapies for depression.

The studies also showed statistically significant improvements in anxiety and global functioning compared to placebo. The most common adverse event was somnolence, headache, dizziness, upper respiratory tract infection, diarrhea, nausea, sedation, vomiting, abnormal dreams and hyperhidrosis. There was no increased suicidal ideation or suicidal behavior compared to baseline.

How to Become a Patient

Frequently Asked Questions about depression during and after pregnancy

How common are maternal mental health disorders? Depression and Anxiety are the most common complications in pregnancy and postpartum. 1 in 7 women suffer from perinatal depression or anxiety. Only 15% of women will seek professional help.

Why don’t women get help?  There is a lack of awareness, screening and easy to access treatment. There is also ongoing stigma surrounding mental health issues and a fear that the baby will be taken away. Women spend a lot of time focused on their “birth plan”, including what pajamas they will wear in the hospital and what poses the birth photographer is going to use. Rarely, is treating or protecting one’s mental health part of the birth and postpartum plan. As women we have set unrealistically high expectations for childbirth and parenting and social media posting is contributing to the overall sense that we as women, and mothers, aren’t meeting expectations if everything isn’t perfect. Developing postpartum depression or anxiety wouldn’t be looked upon favorably by our peers so we don’t talk about it or get treatment. Talking about it opens conversations and helps to identify resources for women to access in their own communities.

What happens without treatment?  Postpartum depression occurs in 20% of postpartum moms and suicide is the most common cause of death in new moms. Without treatment depressed Moms are more likely to have impaired bonding with their babies. Untreated depression and anxiety during and after pregnancy can cause issues with children that are identifiable into adulthood including cognitive and developmental delays; poor self-control and aggression and an increase risk of substance abuse.

Are some women at higher risk for postpartum or maternal mental illness?  Yes, studies have identified certain genetic factors that increase risk of developing postpartum depression, it tends to run in families and women with a history of PMDD are at higher risk of postpartum mood and anxiety disorders. In addition; preexisting depression, anxiety or bipolar depression, a family history of mental illness, a personal history of trauma or abuse, experiencing a stressful event in the last year, an inadequate support system, financial stress, trouble breastfeeding and mom or baby with physical health issues during and after pregnancy.

What can someone do to decrease the risk of developing postpartum depression or anxiety?  In about 60 % of women, depression begins before or during pregnancy, so there is an opportunity to get into treatment before baby arrives. 40% of women don’t have symptoms until the postpartum period. The peak incidence is day 10-19 postpartum. In these women, it’s imperative that family members and health care providers are screening and talking about any concerns they have.

What treatments are available during pregnancy?  Interpersonal psychotherapy is highly effective in helping to develop a support system. Medication is helpful and has been shown to be safe in pregnancy. Risks of untreated mental health disorders are associated with poor health in the mom and baby. Healthy habits like exercise, eating a healthy diet and ensuring restful sleep can help as well. We encourage patients to create a maternal wellness plan to protect their postpartum mental health and be ready to address if it occurs.

What are the risks of medication during pregnancy?  We always need to balance and discuss the risks and benefits of medication treatment and risks of untreated depression. Untreated mental illness is more harmful than any prescribed medications, for mom and baby.

Are medications always required?  Not always, it depends on severity of symptoms and risk factors. We don’t want to wait until symptoms are so severe that hospitalization is required, we want to treat as soon as possible to get mom feeling back to her normal self and protect the mom and baby relationship.

Concerning signs a patient is at risk for postpartum depression

  • Feeling sad, hopeless, empty, or overwhelmed
  • Crying more often than usual or for no apparent reason
  • Worrying or feeling overly anxious
  • Feeling moody, irritable, or restless
  • Oversleeping, or being unable to sleep even when the baby is asleep
  • Having trouble concentrating, remembering details, and making decisions
  • Experiencing anger or rage
  • Losing interest in activities that are usually enjoyable
  • Physical aches and pains, including frequent headaches, stomach problems, and muscle pain
  • Eating too little or too much
  • Withdrawing from or avoiding friends and family
  • Having trouble bonding or forming an emotional attachment with the baby
  • Persistently doubting the ability to care for the baby
  • Thinking about harming herself or the baby
  • History of depression, anxiety/OCD or PPD
  • History of PMDD
  • Prior admission to inpatient psychiatry
  • A history of bipolar disorder or psychosis
  • Family history of mental illness
  • History of or current trauma
  • A stressful event in the last year
  • Single mom
  • Lack of help or support at home from partner or family members
  • Significant financial stress
  • History of infertility treatment
  • Baby with colic, reflux or other health problems
  • A history of previous miscarriage or stillbirth
  • A history of diabetes, thyroid problems
  • Being away from home country or culture
  • Experienced health problems during pregnancy or childbirth
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