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Not actual patients

Understanding postpartum depression

Approximately 1 in 8 moms suffers from PPD symptoms. If left untreated, symptoms may persist for months and up to a year.1,2


What is postpartum depression?

PPD is considered a perinatal/postpartum mood and anxiety disorder and is one of the most common medical complications during and after pregnancy.1,2

The definition of PPD varies among medical organizations:

The American College of Obstetricians and Gynecologists (ACOG) notes that perinatal depression, also known as PPD, includes major and minor depressive episodes that occur during pregnancy or within 12 months of delivery2

According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), PPD is a major depressive episode with peripartum onset, occurring during pregnancy or within the first 4 weeks postpartum3


Symptoms of postpartum depression

A history of depression is one of the greatest risk factors for PPD. According to the DSM-5, at least 5 symptoms of depression, 1 either depressed mood or loss of interest in activities, during the same 2-week period are required to diagnose PPD. Symptoms of PPD include:3,4

  • Depressed mood most of the day, nearly every day (eg, feels sad, empty, hopeless)
  • Markedly diminished interest or pleasure in all, or almost all, activities most of the day, nearly every day
  • Significant weight loss when not dieting or weight gain (change of more than 5% of body weight in a month), or decrease or increase in appetite, nearly every day
  • Insomnia or hypersomnia nearly every day
  • Psychomotor agitation or retardation nearly every day
  • Fatigue or loss of energy nearly every day
  • Feelings of worthlessness or excessive or inappropriate guilt nearly every day
  • Diminished ability to think or concentrate, or indecisiveness, nearly every day
  • Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideation without a specific plan, or a suicide attempt or a specific plan for committing suicide

How to screen for PPD

Screening is the first step to diagnosis of PPD, which may reduce the duration or severity of depressive symptoms.1-3,5,6 The American College of Obstetrics and Gynecology (ACOG) recommends screening for PPD using a validated screening tool at least once during the perinatal period, including a mandatory assessment at the comprehensive postpartum visit, which should be conducted no later than 12 weeks after birth.2,7 Approximately 50% of cases may go undiagnosed without proper screening.

PPD is a serious and debilitating condition for new moms, so be sure to encourage discussion around available treatment options to help address depressive symptoms.

While there is evidence that screening alone can have clinical benefits, the initiation of treatment or referral to mental healthcare providers can maximize those benefits.2,7


The Edinburgh Postnatal Depression Scale (EPDS)

The EPDS is a validated screening tool for PPD. The EPDS questionnaire asks women to self-report their experiences in the last week using 10 simple questions. It takes approximately 5 minutes to complete.7-9

A person scoring 12/13 or above is most likely suffering from depression in the peripartum period. Data suggest that lowering the threshold to a score of 9/10 may increase the detection of symptoms of PPD.9

Mom talking to Doctor

If you feel a patient would benefit from treatment with ZULRESSO® (brexanolone), you can start the process of enrolling them with the ZULRESSO Risk Evaluation and Mitigation Strategy (REMS) and getting them started on their path to treatment.

See more about ZULRESSO REMS and patient enrollment

INDICATION

ZULRESSO® is indicated for the treatment of postpartum depression in adults.

IMPORTANT SAFETY INFORMATION

WARNING: EXCESSIVE SEDATION AND SUDDEN LOSS OF CONSCIOUSNESS

Patients treated with ZULRESSO are at risk of excessive sedation or sudden loss of consciousness during administration.

Because of the risk of serious harm, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring. Patients must be accompanied during interactions with their child(ren).

Because of these risks, ZULRESSO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ZULRESSO REMS.

WARNINGS AND PRECAUTIONS

Excessive Sedation and Sudden Loss of Consciousness

In clinical studies, 5% of ZULRESSO-treated patients compared to 0% of placebo-treated patients experienced sedation and somnolence that required dose interruption or reduction. Loss of consciousness or altered state of consciousness was reported in 4% of ZULRESSO-treated patients compared with 0% of placebo-treated patients.

During the infusion, monitor patients for sedative effects every 2 hours during planned, non-sleep periods. Immediately stop the infusion if there are signs or symptoms of excessive sedation. After symptoms resolve, the infusion may be resumed at the same or lower dose as clinically appropriate. Immediately stop the infusion if pulse oximetry reveals hypoxia. After hypoxia, the infusion should not be resumed.

Concomitant use of opioids, antidepressants, or other CNS depressants such as benzodiazepines or alcohol may increase the likelihood or severity of adverse reactions related to sedation. Patients must be accompanied during interactions with their child(ren) while receiving the infusion because of the potential for excessive sedation and sudden loss of consciousness.

Patients should be cautioned against engaging in potentially hazardous activities requiring mental alertness, such as driving, after infusion until any sedative effects of ZULRESSO have dissipated.

ZULRESSO Risk Evaluation and Mitigation Strategy (REMS)

ZULRESSO is available only through a restricted program under a REMS called the ZULRESSO REMS because excessive sedation or sudden loss of consciousness can result in serious harm.

Notable requirements of the ZULRESSO REMS include:

  • Healthcare facilities must enroll in the program and ensure that ZULRESSO is only administered to patients who are enrolled in the
    ZULRESSO REMS
  • Pharmacies must be certified with the program and must only dispense ZULRESSO to healthcare facilities who are certified in the
    ZULRESSO REMS
  • Patients must be enrolled in the ZULRESSO REMS prior to administration of ZULRESSO
  • Wholesalers and distributors must be registered with the program and must only distribute to certified healthcare facilities and pharmacies

Further information, including a list of certified healthcare facilities, is available at www.zulressorems.com or call 1-844-472-4379.

Suicidal Thoughts and Behaviors

In pooled analyses of placebo-controlled trials of chronically administered antidepressant drugs (SSRIs and other antidepressant classes) that include 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).

ZULRESSO does not directly affect monoaminergic systems. Because of this and the comparatively low number of exposures to ZULRESSO, the risk of developing suicidal thoughts and behaviors with ZULRESSO is unknown. If depression becomes worse or patients experience emergent suicidal thoughts and behaviors, consider changing the therapeutic regimen, including discontinuing ZULRESSO.

Adverse Reactions

The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were sedation/somnolence, dry mouth, loss of consciousness, and flushing/hot flush.

Use in Specific Populations

  • Pregnancy: Based on findings from animal studies of other drugs that enhance GABAergic inhibition, ZULRESSO may cause fetal harm
  • Lactation: Brexanolone is transferred to breastmilk in nursing mothers. There are no data on the effects of ZULRESSO on a breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZULRESSO and any potential adverse effects on the breastfed child from ZULRESSO or from the underlying maternal condition
  • Pediatric Use: The safety and effectiveness of ZULRESSO in pediatric patients have not been established
  • Renal Impairment: No dosage adjustment is recommended in patients with mild, moderate, or severe renal impairment. Avoid use of ZULRESSO in patients with end stage renal disease (ESRD)

Controlled Substance

ZULRESSO contains brexanolone, a Schedule IV controlled substance under the Controlled Substances Act.

Please also see Full Prescribing Information including Boxed Warning and Medication Guide for ZULRESSO.

To report SUSPECTED ADVERSE REACTIONS, contact Sage Therapeutics, Inc. at 1-844-4-SAGERX (1-844-472-4379) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATION
ZULRESSO® is indicated for the treatment of postpartum depression in adults.

IMPORTANT SAFETY INFORMATION
WARNING: EXCESSIVE SEDATION AND SUDDEN LOSS OF CONSCIOUSNESS
Patients treated with ZULRESSO are at risk of excessive sedation or sudden loss of consciousness during administration.
Because of the risk of serious harm, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring. Patients must be accompanied during interactions with their child(ren).
Because of these risks, ZULRESSO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ZULRESSO REMS.

References

  1. Bauman BL, Ko JY, Cox S, et al. Vital signs: postpartum depressive symptoms and provider discussions about perinatal depression—United States 2018, MMWR Morb Mortal Wkly Rep. 2020;69(19):575-581.
  2. American College of Obstetricians and Gynecologists. Optimizing postpartum care. ACOG Committee Opinion No. 736. Obstet Gynecol. 2018;131(5):e140-e150.
  3. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. American Psychiatric Association Publishing; 2013.
  4. National Institute of Mental Health. Depression. https://www.nimh.nih.gov/health/publications/depression/index.shtml. Accessed September 2021.
  5. Silverman ME, Reichenberg A, Savitz DA, et al. The risk factors for postpartum depression: a population-based study. Depress Anxiety. 2017;34(2):178-187.
  6. 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.
  7. American College of Obstetricians and Gynecologists. Screening for perinatal depression. ACOG Committee Opinion No. 757. Obstet Gynecol. 2018;132(5):e208-e212.
  8. Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression: development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987;150:782-786.
  9. Moses-Kolko EL, Roth EK. Antepartum and postpartum depression: healthy mom, healthy baby. J Am Med Womens Assoc. 2004;59(3):181-191.