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Understanding postpartum depression

Approximately 1 in 8 moms in the US report experiencing symptoms of postpartum depression. 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 more 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 has been associated with a highly elevated risk for PPD. According to the DSM-5, during the same 2-week period of depressed mood or loss of interest or pleasure, moms can experience other symptoms including: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

Approximately 50% of cases may go undiagnosed. The American College of Obstetrics and Gynecology (ACOG) states that screening alone can have clinical benefits, although initiation of treatment or referral to mental health care providers offers maximum benefits.1-3,5,6 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

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.

The Edinburgh Postnatal Depression Scale (EPDS)

The EPDS is a validated screening tool for PPD. It consists of 10 questions regarding how patients felt and the frequency of their symptoms over the previous 7 days. 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

  • Any person answering the self-harm question affirmatively should be referred to a psychiatrist immediately. Always ensure your patient is talking to their healthcare provider if there is potential immediate harm or call 911.9
  • People screening positive for symptoms of PPD should be further assessed by a healthcare provider to confirm whether or not clinical depression is present. Screening tools are not a substitute for this clinical assessment, and scores just below the cutoff should not be taken to indicate the absence of depression, especially if the healthcare provider has other reasons to consider this diagnosis.8,9
Download the Edinburgh Postnatal Depression Scale
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 (PPD) in patients 15 years and older.

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 in adults, ZULRESSO caused sedation and somnolence that required dose interruption or reduction in some patients during the infusion (5% of ZULRESSO-treated patients compared to 0% of placebo-treated patients). Some adult patients were also reported to have loss of consciousness or altered state of consciousness during the ZULRESSO infusion (4% of the ZULRESSO-treated patients compared with 0% of the placebo-treated patients). Time to full recovery from loss or altered state of consciousness, after dose interruption, ranged from 15 to 60 minutes in clinical studies in adults. A healthy 55-year-old man participating in a cardiac repolarization study experienced severe somnolence and <1 minute of apnea while receiving two times the maximum recommended dosage of ZULRESSO (180 mcg/kg/hour).

In an open-label clinical study in 20 patients ages 15 to 17 years, one patient experienced dizziness and loss of consciousness.

All patients with loss of or altered state of consciousness recovered with dose interruption. There was no clear association between loss or alteration of consciousness and pattern or timing of dose. Not all patients who experienced a loss or alteration of consciousness reported sedation or somnolence before the episode.

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.

Adverse reactions reported in an open-label study in patients 15 to 17 years were generally similar to those observed in clinical studies of ZULRESSO in adults with PPD.

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 for the treatment of PPD have been established in patients 15 to 17 years. The safety and effectiveness of ZULRESSO in patients less than 15 years of age 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 patients 15 years and older.

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.