Here’s What You Need to Know About the Latest FDA-Approved Postpartum Depression Pill, Zurzuvae™ (Zuranolone)

Key Takeaways

  • Postpartum Depression (PPD) impacts millions of women worldwide.  It affects up to 1 in 7 women, 75% of women receive no treatment.  Alarmingly, suicide combined with overdose is the leading cause of death in the postpartum period. Symptoms of PPD include intense feelings of sadness, worthlessness, guilt, sleep disturbances, and even thoughts of self-harm.
  • The FDA approved Zurzuvae (zuranolone) as the first and only oral, once-daily, 14-day treatment medication that can provide rapid improvements in depressive symptoms for women with PPD.
  • Zurzuvae is expected to be a less costly and more accessible alternative to the only other drug approved for postpartum depression called Zulresso (brexanolone), which requires a 60-hour intravenous infusion in a clinic or a hospital.

Navigating through motherhood is a journey filled with emotional highs and lows, but for some women, this beautiful transition can lead to a daunting Mental Health condition known as Postpartum Depression (PPD). Affecting approximately 1 in 7 women worldwide, PPD extends beyond mere baby blues, signifying a profound psychological issue that necessitates prompt identification and referral to empathic and expert treatment with psychotherapy and often medication.

Postpartum depression is more than a fleeting state of mind. It’s a widespread issue affecting millions of women globally, transcending cultural and geographical boundaries. According to the National Alliance on Mental Illness, PPD is often overshadowed and misunderstood as the general “baby blues.” However, this condition lasts much longer than the baby blues and encompasses a wider range of symptoms that go beyond temporary or fleeting feelings of sadness. As common as PPD is, the vast majority of women with PPD go undiagnosed and untreated.  Barriers to accessing care include a general lack of awareness in patients and families, inadequate screening by health care providers, and limited access to affordable mental health care.  Persistent mental health stigma and widely accepted but unrealistic expectations of pregnancy, childbirth and motherhood add to the shame and guilt women with PPD experience, preventing many from seeking help.

Recognizing PPD requires an understanding of its multifaceted symptoms. These symptoms represent a profound disturbance that goes beyond mere fatigue or Anxiety associated with new motherhood. Women suffering from Postpartum Depression may experience intense feelings of sadness, worthlessness, guilt, sleep disturbances, and even thoughts of self-harm.

Current treatments for postpartum depression include therapy, antidepressant medications like selective serotonin reuptake inhibitors (SSRIs), a continuous IV infusion over a total of 60 hours (2.5 days), and hormone therapy. These methods can be effective, but they might not work for everyone and can take time to show results.

However, a new postpartum depression treatment pill called Zurzuvae, recently approved after extensive clinical trials, is now heralded as a breakthrough. Zurzuvae (zuranolone) offers a unique mechanism of action, providing faster relief from postpartum depression symptoms by targeting specific neuroreceptors. Its rapid onset and fewer side effects provide hope for new mothers seeking swift and efficient recovery, potentially revolutionizing postpartum depression treatment.

Zurzuvae (zuranolone), is a once-daily oral pill taken for just two weeks and works much faster than other antidepressants.

Zurzuvae (zuranolone) vs Zulresso (brexanolone)

The only other drug approved for postpartum depression is brexanolone, marketed as Zulresso. But brexanolone, approved in 2019, requires a 60-hour intravenous infusion in a hospital or a clinic. Although the average out of pocket cost for a patient with health insurance is often less than $100, the cost of care is significant, the medication alone costs an average of $34,000, making it inaccessible to any woman without insurance coverage. 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.

Zulresso can cause serious side effects, such as sedation and loss of consciousness. These transient side effects necessitate monitoring and thoughtful education of patients and their families regarding safety.  Patients should avoid making big decisions, driving a car or operating heavy machinery and unassisted caretaking of their baby or young children during treatment. 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. 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 rapid and high rate of response when compared with other traditional pharmacotherapies for depression.

However, the fast-acting pill Zurzuvae can improve symptoms in as little as three days. In addition, taking a pill for two weeks is much easier, not requiring a mother to leave her baby for several days. Zurzuvae is a neuroactive steroid that works as a positive allosteric modulator of GABA-A receptors. Lower levels of GABA in the body have been linked to depression.

Drugmakers Sage Therapeutics and Biogen haven’t released the Zurzuvae price tag, but most analysts expect it to be lower than Zulresso pricing.

Zurzuvae (zuranolone) vs Antidepressants (SSRIs)

As a part of PDD treatment, clinicians have prescribed selective serotonin reuptake inhibitors (SSRIs). Compared to SSRIs, this newly approved drug works faster and with fewer doses than existing treatments. For example, SSRIs typically take 4 to 6 weeks to demonstrate improvement in mothers’ symptoms. Zuranolone is only a 2-week daily oral dose.

The majority of trial participants reported improvements in just three days of use. The mechanism of intervention is different as SSRIs work by increasing levels of serotonin in the brain while Zurzuvae (zuranolone) is a synthetic hormone replacement of allopregnanolone that helps calm down stress responses. Allopregnanolone is a naturally occurring neurosteroid that is produced in the brain from the hormone progesterone. Low levels of allopregnanolone have been associated with depressed mood. As allopregnanolone production is associated with progesterone, the dramatic drop of progesterone post-delivery leads to a correlating drop in allopregnanolone.

Zuranolone can offer relief by addressing this known hormone imbalance. For so many people affected by postpartum depression, this new drug is hope. Its specific intended use, or indication, for PPD could also reduce stigma and increase willingness to take the drug.

Zurzuvae’s Leap Forward

The breakthrough of Zurzuvae in the world of Mental Health care is an unprecedented stride toward treating Postpartum Depression. A recent FDA announcement praises the medication’s distinctively swift action and efficacy.

Unlike existing treatments, Zurzuvae’s action is not only rapid but also sustained, offering lasting relief. Its approval represents a monumental advancement in Mental Health care and provides a hopeful path to recovery for many women.

Additionally, as an acute therapy administered for just two weeks, Zurzuvae will be particularly attractive for patients who don’t want to be locked into taking long-term antidepressant maintenance therapy, especially mothers who may be concerned about any medication they take entering their breast milk.

Exploring Other Treatment Avenues for Postpartum Depression

Zurzuvae’s approval doesn’t eclipse other treatment avenues for Postpartum Depression. Every individual is unique, and the treatment must be tailored to personal needs and preferences. Options range from Individual or Group Therapy to Cognitive Behavioral approaches, Family Therapy, or alternative treatments. LifeStance offers an array of services catering to individual needs, ensuring that every woman has access to the Mental Health care that suits her best.

Some of these additional services include:

  • Anti-Anxiety or antidepressant medications
  • Psychotherapy
  • Participation in a group setting for emotional support and education

Bridging the Gap: From Awareness to Care

Postpartum Depression is a complex and sensitive issue. Beyond medications like Zurzuvae, recognizing the symptoms, understanding the available treatment options, and approaching the condition with compassion and empathy is vital.

Those interested in managing or supporting Depression might find healthy habits to support Depression treatment helpful. Additionally, general tips for managing Depression may also complement PPD treatment.

Zurzuvae stands as a beacon of hope for many and shows great promise for revolutionizing treatment for PPD.

Its unique properties, quick action, and lasting formula make it a promising option. However, a full spectrum of treatment choices, from therapy to medications, must be considered. If you or someone you know is experiencing signs of Postpartum Depression, the expert providers at LifeStance can guide you on the journey to recovery.

If you or someone you know may be struggling with suicidal thoughts, dial 988 to reach someone with the Suicide and Crisis Lifeline. They’re available 24 hours a day and provide services in multiple languages.

Authored By 

LifeStance Health
LifeStance Health

LifeStance is a mental healthcare company focused on providing evidence-based, medically driven treatment services for children, adolescents, and adults.