There’s no time to wait to talk to your patients about postpartum depression (PPD)

Prevalence
Risk factors
Symptoms
Screening

Prevalence

PPD is one of the most common medical conditions associated
with pregnancy,1 yet it is underdiagnosed and undertreated1-3

About 1 in 8 women report experiencing symptoms of
postpartum depression after giving birth4

Risk factors

Women often have numerous and overlapping factors that may compound risk for PPD1,5

Biological1,6-8*
  • Personal and family history of depression
  • Sleep disturbances
  • Hormonal changes
  • Genetics
Environmental1,9,10*
  • Stressful life events
  • Childcare stress
  • Partner violence
Obstetric5,11,12*
  • Obstetric complications
  • Traumatic birth experience
  • Difficulty breastfeeding
Psychosocial1,5*
  • Lack of social support
  • Race (as a social construct)
  • Employment status
  • Socioeconomic status
  • Pregnancy intendedness

*Not an all-inclusive list of risk factors associated with PPD.

Any woman can be at risk for PPD13

Symptoms

PPD symptom onset can occur during or after pregnancy1,14

While PPD symptoms may look like the baby blues, there are key differences5

Baby blues symptoms peak around 5 days postpartum and resolve within 2 weeks5,13

PPD symptoms are present for at least 2 weeks and cause significant distress or functional impairment1,14

Patients with a PPD diagnosis may be struggling with persistent symptoms that can be debilitating1,13,14

Mood5,13,14

  • Persistent sad or “empty” mood
  • Loss of interest or pleasure in daily activities
  • Irritability or frustration
  • Feelings of worthlessness or guilt
  • Hopelessness or pessimism
  • Anxiety or obsessive thinking
  • Feeling overwhelmed
  • Uncontrollable anger
  • Thoughts of death, suicide attempts, or self-harm

Cognitive13,14

  • Impaired ability to think or concentrate
  • Difficulty making decisions
  • Memory problems

Somatic/psychomotor13,14

  • Difficulty sleeping, waking early, or oversleeping
  • Restlessness or having trouble sitting still
  • Abnormal changes in weight or appetite
  • Fatigue or abnormal decrease in energy

Infant-related13

  • Trouble bonding or forming an attachment with the baby
  • Persistent doubts about ability to care for the baby
  • Thoughts of infant-related harm

Provide your patients with this guide to help them talk about depressive symptoms they may be experiencing

Screening

Screening early and often may support timely intervention1

ACOG recommends screening for depressive symptoms at multiple timepoints1

Patients should be screened for depressive symptoms at multiple timepoints during pregnancy and after delivery
using standardized and validated instruments like the EPDS or PHQ-91

About 50%
of women with a PPD diagnosis began experiencing depressive symptoms during pregnancy14
Get the EPDS screener tool
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ACOG, American College of Obstetricians and Gynecologists; EPDS, Edinburgh Postnatal Depression Scale; PHQ-9, Patient Health Questionnaire-9.

ACOG recommends screening for bipolar disorder before initiating pharmacotherapy for depression, if not previously done.1

ACOG recommends consideration of zuranolone for treatment of postpartum depression15

ACOG recommends consideration of zuranolone in the postpartum period (ie, within 12 months postpartum) for depression that has onset in the third trimester or within 4 weeks postpartum. The decision to use zuranolone should balance the benefits with the risks and challenges.15

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Learn about the 3 steps needed to start your patients with PPD on ZURZUVAE

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References: 1. American College of Obstetricians and Gynecologists. Screening and Diagnosis of Mental Health Conditions During Pregnancy and Postpartum: ACOG Clinical Practice Guideline No. 4. Obstet Gynecol. 2023;141(6):1232-1261. 2. Cox EQ, Sowa NA, Meltzer-Brody SE, et al. The Perinatal Depression Treatment Cascade: Baby Steps Toward Improving Outcomes. J Clin Psychiatry. 2016;77(9):1189-1200. 3. Sidebottom AC, Vacquier M, LaRusso E, et al. Prenatal and postpartum depression diagnosis in a large health system: prevalence and disparities. Ann Med. 2023;55(2):1-13. 4. Data on File. Biogen and Sage Therapeutics, Inc. 2024. 5. Thurgood S, Avery DM, Williamson L. Postpartum depression (PPD). Am J Clin Med. 2009;6:17-22. 6. Okun ML, Mancuso RA, Hobel CJ, et al. Poor Sleep Quality Increases Symptoms of Depression and Anxiety in Postpartum Women. J Behav Med. 2018;41(5):703-710. 7. Meltzer-Brody S, Kanes SJ. Allopregnanolone in postpartum depression: Role in pathophysiology and treatment. Neurobiol Stress. 2020;12:100212. 8. Guintivano J, Manuck T, Meltzer-Brod S. Predictors of Postpartum Depression: A Comprehensive Review of the Last Decade of Evidence. Clin Obstet Gynecol. 2018;61(3):591-603. 9. Qobadi M, Collier C, Zhang L. The Effect of Stressful Life Events on Postpartum Depression: Findings from the 2009–2011 Mississippi Pregnancy Risk Assessment Monitoring System. Matern Child Health J. 2016;20(suppl 1):164-172. 10. Norhayati MN, Hazlina NHN, Asrenee AR, et al. Magnitude and risk factors for postpartum symptoms: A literature review. J Affect Disord. 2015;175:34-52. 11. Robertson E, Grace S, Wallington T, et al. Antenatal risk factors for postpartum depression: a synthesis of recent literature. Gen Hosp Psychiatry. 2004;26(4):289-295. 12. Waller R, Kornfield SL, White LK, et al. Clinician-reported childbirth outcomes, patient-reported childbirth trauma, and risk for postpartum depression. Arch Womens Ment Health. 2022;25(5):985-993. 13. Perinatal depression. National Institutes of Mental Health. https://www.nimh.nih.gov/health/publications/perinatal-depression. Accessed February 10, 2024. 14. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed, Text Revision. American Psychiatric Publishing; 2022. 15. ACOG Practice Advisory. Zuranolone for the Treatment of Postpartum Depression. 2023. Updated January 30, 2024. Accessed August 8, 2024.

INDICATION

ZURZUVAE® (zuranolone) is indicated for the treatment of postpartum depression (PPD) in adults.

 

IMPORTANT SAFETY INFORMATION

 

WARNING: IMPAIRED ABILITY TO DRIVE OR ENGAGE IN OTHER POTENTIALLY HAZARDOUS ACTIVITIES

ZURZUVAE causes driving impairment due to central nervous system (CNS) depressant effects.

Advise patients not to drive or engage in other potentially hazardous activities until at least 12 hours after ZURZUVAE administration for the duration of the 14-day treatment course. Inform patients that they may not be able to assess their own driving competence, or the degree of driving impairment caused by ZURZUVAE.

 

WARNINGS AND PRECAUTIONS

 

Impaired Ability to Drive or Engage in Other Potentially Hazardous Activities

  • ZURZUVAE causes driving impairment due to central nervous system (CNS) depressant effects
  • Advise patients not to drive a motor vehicle or engage in other potentially hazardous activities requiring complete mental alertness, such as operating machinery, until at least 12 hours after ZURZUVAE administration for the duration of the 14-day treatment course. Inform patients that they may not be able to assess their own driving competence or the degree of driving impairment caused by ZURZUVAE

Central Nervous System Depressant Effects

  • ZURZUVAE can cause CNS depressant effects such as somnolence and confusion
  • Somnolence developed in 36% of patients who received ZURZUVAE (50 mg) and in 6% of patients who received placebo daily. Some ZURZUVAE-treated patients developed confusional state. One of these cases was severe, and was also associated with somnolence, dizziness, and gait disturbance
  • A higher percentage of ZURZUVAE-treated patients, compared to placebo-treated patients, experienced somnolence, dizziness, or confusion that required dosage reduction, interruption, or discontinuation
  • Because ZURZUVAE can cause CNS depressant effects, patients may be at higher risk of falls
  • Other CNS depressants such as alcohol, benzodiazepines, opioids, tricyclic antidepressants, or drugs that increase zuranolone concentration, may increase impairment of psychomotor performance or CNS depressant effects such as somnolence, cognitive impairment, and the risk of respiratory depression in ZURZUVAE-treated patients
  • To reduce the risk of CNS depressant effects and/or mitigate CNS depressant effects that occurs with ZURZUVAE treatment:
    • If patients develop CNS depressant effects, consider dosage reduction or discontinuation of ZURZUVAE
    • If use with another CNS depressant is unavoidable, consider dosage reduction
    • Reduce the ZURZUVAE dosage in patients taking strong CYP3A4 inhibitors
 

Suicidal Thoughts and Behavior

  • In pooled analyses of placebo-controlled trials of chronically administered antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with major depressive disorder (MDD)
  • ZURZUVAE does not directly affect monoaminergic systems. Consider changing the therapeutic regimen, including discontinuing ZURZUVAE, in patients whose depression becomes worse or who experience emergent suicidal thoughts and behaviors

Embryo-fetal Toxicity

  • Based on findings from animal studies, ZURZUVAE may cause fetal harm when administered to a pregnant woman
  • Advise a pregnant woman of the potential risk to an infant exposed to ZURZUVAE in utero. Advise females of reproductive potential to use effective contraception during treatment with ZURZUVAE and for one week after the final dose
 

ADVERSE REACTIONS

 
  • The most common adverse reactions (≥5% and greater than placebo) in ZURZUVAE-treated patients were somnolence, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection

 

DRUG INTERACTIONS

 

CNS Depressant Drugs and Alcohol

  • Caution should be used when ZURZUVAE is administered in combination with other CNS drugs or alcohol. If use with another CNS depressant is unavoidable, consider dosage reduction

Strong CYP3A4 Inhibitors

  • Reduce the ZURZUVAE dosage when used with a strong CYP3A4 inhibitor

CYP3A4 Inducers

  • Avoid concomitant use of ZURZUVAE with CYP3A4 inducers
 

USE IN SPECIFIC POPULATIONS

Pregnancy

  • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including ZURZUVAE, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/
  • Based on findings from animal studies, ZURZUVAE may cause fetal harm. Advise pregnant women of the potential risk to a fetus. Available data on ZURZUVAE use in pregnant women from the clinical development program are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Lactation

  • Available data from a clinical lactation study in 14 women indicate that zuranolone is present in low levels in human milk. There are no data on the effects of zuranolone on a breastfed infant and limited data on the effects on milk production
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZURZUVAE and any potential adverse effects on the breastfed child from ZURZUVAE or from the underlying maternal condition

Hepatic Impairment

  • The recommended ZURZUVAE dosage in patients with severe hepatic impairment (Child-Pugh C) is lower than patients with normal hepatic function

Renal Impairment

  • The recommended ZURZUVAE dosage in patients with moderate and severe renal impairment is lower than those with normal renal function
 

DRUG ABUSE AND DEPENDENCE

 
  • ZURZUVAE contains zuranolone, a Schedule IV controlled substance
  • Zuranolone has abuse potential with associated risks of misuse, abuse, and substance use disorder including addiction
  • ZURZUVAE may produce physical dependence
 
 

Please see full Prescribing Information, including Boxed Warning.

 
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