On March 19, 2019, the Food & Drug Administration (FDA) approved Zulresso, the first-ever drug designed to treat postpartum depression (PPD). Zulresso is the brand name for a drug called brexanolone that works by mimicking progesterone and estrogen, two hormones in a woman’s body that often drop quickly after birth. By giving Zulresso, these hormones are replaced and the levels become more stable, improving the symptoms of PPD. Zulresso is the first drug for PPD developed to work in this way.

A Breakthrough in Postpartum Depression Treatment

PPD is a serious mood problem that occurs in women after having a baby. Doctors think that this condition is at least partially caused by the changing hormone levels in a woman’s body after giving birth.

Symptoms of PPD include:

  • Feeling sad or hopeless
  • Crying
  • Frequent bouts of worry or anger
  • Mood changes
  • Trouble bonding with one’s baby baby
  • Not being interested in their baby’s development
  • Thinking negative thoughts about their baby
  • Doubting their ability to care for their baby
  • Thinking about hurting herself or her baby

Up to this point, PPD has been treated in a few different ways. Doctors often first recommend therapy for PPD. One big reason for this is that a lot of drugs can be transmitted to infants through breast milk. If therapy does not improve symptoms, antidepressant medications may be prescribed. However, all the drugs used for PPD up until now were designed for other kinds of depression. An imperfect solution is better than no solution when it comes to PPD. When left untreated, PPD may lead to other issues like:

  • Trouble breastfeeding
  • Problems with the baby’s sleep
  • Problems with the baby’s development
  • Lower baby vaccination rates
  • Harsh parenting style
  • Marriage and relationship problems
  • Harming to oneself or one’s baby

Around 15 percent of women develop PPD. Although PPD can occur at any time in the first year after giving birth, more than 90 percent of women will get it within the first four months after birth.

Risk factors for PPD include:

  • Depression with other pregnancies
  • Prior mental health issues
  • Family history of mental health issues
  • Stress during or after being pregnant
  • Medical problems while pregnant or after birth
  • Negative attitude about being pregnant
  • Not having a strong family support system
  • History of substance abuse

Clinical Trials

Zulresso was studied in a few different trials. During these trials, doctors found that patients who took Zulresso had faster and more significant improvement in their PPD symptoms than patients who received a placebo. Symptom improvement started within days and remained a month after the treatment was finished.

While these trials were largely successful, doctors did find some side effects associated with Zulresso use, including:

  • Dizziness
  • Drowsiness
  • Passing out
  • Increased heartbeat
  • Headache
  • Flushing
  • Dry mouth

What This Means for the Future of PPD Treatment

Zulresso is likely to be reserved for women with severe cases of PPD. Some drawbacks will likely doctors from subscribing the medication to all women with PPD, including:

  • The medication can only be administered through an IV continuously over 60 hours (2.5 days)
  • Zulresso must be given in the hospital
  • The medication is currently expensive
  • Mothers must be watched during all contact with the baby after receiving the medication since drowsiness is a common side effect

Even so, Zulresso’s FDA approval is an important milestone in PPD treatment. Doctors hope that even if the drug is not used in a lot of women, it will lessen the stigma surrounding PPD. In turn, that may lead to more women seeking help for postpartum depression. Scientists are now studying to see if other similar drugs can be developed to help treat PPD.

Key Points: Zulresso and PPD

  • PPD occurs in 15 percent of women after pregnancy and can lead to serious problems for both mother and baby
  • Zulresso is the first drug of its kind
  • It is also the first drug the FDA has approved explicitly for PPD
  • It has been found to work within days, and the effects are long-lasting
  • Zulresso does carry some potentially dangerous side effects, including extreme sleepiness
  • Because Zulresso is currently expensive and requires a hospital stay, it is not likely to be used in all women with PPD
  • Scientists are working on new, similar drugs that also may help treat PPD

Some mothers who grapple with PPD may turn to substance use to find relief from their symptoms. If you or someone you love is living with co-occurring PPD and addiction, know that help is available. The Recovery Village specializes in dual diagnosis treatment for mental health and substance use disorders. Reach out to a representative today for more information.

    

Food and Drug Administration. “FDA approves first treatment for post-partum depression.” March 19, 2019.  Accessed April 8, 2019.

National Institute of Mental Health. “Postpartum Depression Facts.” (n.d.) Accessed April 4, 2019.

Archives of General Psychiatry. “Psychiatric disorders in pregnant and postpartum women in the United States.” July 2008. Accessed April 4, 2019.

Journal of Clinical Psychiatry. “Phenotypic differences between pregnancy-onset and postpartum-onset major depressive disorder.” December 2012. Accessed April 4, 2019.

Infant Behavior and Development. “Postpartum Depression Effects on Early Interactions, Parenting, and Safety Practices: A Review.” February 2010. Accessed April 4, 2019.

The American College of Obstetricians and Gynecologists. “FAQ: Postpartum Depression.” December 2013. Accessed April 8, 2019.

Lancet. “Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial.” July 29, 2017. Accessed April 8, 2019.

Lancet. “Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials.” September 22, 2018. Accessed April 8, 2019.

 

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