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.
What to Expect with Zulresso 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, allowing 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.
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.
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.