Postpartum Depression Pill Approved by the FDA

By Published On: August 8th, 2023

The 14-day treatment is the first oral pill to receive FDA approval specifically for postpartum depression.

Content Warning: This article discusses distressing themes, including suicide. 

Over the last decade or so, talking about postpartum depression (PPD) has become more and more normalized, which has spotlighted just how prevalent the mood disorder is. It’s estimated that around one in seven birthing parents experience symptoms of postpartum depression, which differ from the “baby blues” because they last longer than two weeks after the baby is born. Left untreated, PPD can become so severe that a birthing parent will have thoughts of, attempt, or complete suicide. In fact, suicide is the leading cause of maternal death in the first year after a baby is born.

Given these grim statistics, it’s clear that more needs to be done to support parents who are trying to adjust to life with a newborn while simultaneously coping with PPD. While common antidepressant medications, like Zoloft and Prozac, have long been the standard of care for PPD, on August 4, the US Food and Drug Administration (FDA) approved Zurzuvae, the first oral medication developed especially to treat PPD.

What is the PPD Pill?

Zurzuvae, the brand name for the drug zuranolone, is manufactured by Sage Therapeutics out of Cambridge, Massachusetts. It’s a once-daily oral pill that is taken over the course of 14 days and has been shown to “provide rapid improvements in depressive symptoms for [birthing parents] with PPD.” In clinical trials, the FDA says the effects of treatment lasted for four weeks (or 42 days) after the final dose of medication; however, longer-term effects are not known because trials did not follow up with patients after 45 days.

Prior to this most recent approval, in 2019, the FDA approved another PPD-specific treatment by Sage Therapeutics called Zulresso, the brand name for brexanolone. At the time, it was the first-ever treatment that specifically targeted PPD. However, while it was proven to be effective in improving the symptoms of PPD, receiving the treatment was incredibly inconvenient for a new parent because it required a 2 ½ day stay at a medical facility for 60 hours of continuous intravenous treatment. Now that this 14-day oral treatment is available, more birthing parents will be able to realistically take advantage of it without having to leave their newborn at home overnight.

When Will the PPD Pill Be Available?

In a recent press release, Sage Therapeutics explained that the next step in making the drug commercially available, it needs to be scheduled as a controlled substance by the US Drug Enforcement Administration (DEA). This typically happens within 90 days of FDA approval, and Sage Therapeutics anticipates that Zurzuvae will be available to consumers between October and December 2023.

How Much Will Zurzuvae Cost?

This is always the big question with new prescription medications (especially when it comes to healthcare in the U.S. … but that’s a topic for another day). At this point, Sage Therapeutics has not released how much they plan to charge for the drug, so whether or not it will be affordable is up in the air, as is whether or not insurers will cover it. We do know that Zulresso, which is very similar in makeup to Zurzuvae, costs $34,000 for the 2 ½ day treatment. In Zulresso’s case, many large insurers like Aetna, United Healthcare, and Cigna will cover the medication if it is deemed medically necessary, and Sage Therapeutics offers financial assistance to patients with high copays or who are uninsured or underinsured and meet certain criteria.

What Are the Side Effects?

As with most prescription medications, it’s important to be aware of the side effects of Zurzuvae before beginning treatment. In their press release, Sage Therapeutics lists the following common side effects:

  • Decreased ability to drive or do other dangerous activities for 12 hours after dose
  • Decreased alertness and awareness, including drowsiness, trouble walking, sleepiness, confusion, dizziness, and slow thinking
  • Illness or feeling unwell, including common cold, diarrhea, feeling weak, low energy, and urinary tract infection (UTI)
  • May increase the risk of suicidal thoughts and actions in patients 24 years old and younger

Also, Sage Therapeutics says patients taking Zurzuvae should not drink alcohol, should not take opioids, and should not take other medications that cause central nervous system depressive symptoms. They also warn against becoming pregnant while taking Zurzuvae and recommend using birth control until at least a week after your last dose of medication.

Is the PPD Pill Safe for Breastfeeding?

Just like during pregnancy, nursing parents need to be mindful about what medications they take while breastfeeding, as not all are considered safe—including some antidepressants used to treat PPD. At this time, the safety of Zurzuvae while breastfeeding is unknown. According to their press release, Sage Therapeutics says, “Zurzuvae passes into breast milk, and it is not known if it can harm your baby. Talk to your health care provider about the risks and benefits of breastfeeding and about the best way to feed your baby during treatment with Zurzuvae.”

While Zurzuvae is by no means a magic pill or the answer to all of our postpartum concerns, having another treatment option for PPD is still a big win for birthing parents. If you are having feelings of sadness, hopelessness, anxiety, overwhelm, worthlessness, or trouble sleeping, speak to your health care provider for help and guidance.

If you are currently experiencing a mental health crisis, go to your nearest emergency department or dial 988 to reach the suicide and crisis lifeline.