When is Zuranolone (suvorexant) prescribed?

From the Guidelines

Zuranolone is prescribed for the treatment of postpartum depression (PPD) in adults, not for insomnia or sleep disorders, as there is no evidence in the provided studies to support its use for these conditions. The provided evidence focuses on the treatment of insomnia and sleep disorders, and does not mention Zuranolone as a treatment option for these conditions 1.

Key Considerations

• The studies provided do not support the use of Zuranolone for insomnia or sleep disorders, but rather discuss other medications such as suvorexant, eszopiclone, and zolpidem as treatment options for these conditions 1.
• Zuranolone is actually used for the treatment of postpartum depression (PPD) in adults, and is administered as a 14-day oral treatment course at a dose of 50 mg (two 25 mg tablets) taken once daily with food.
• Patients should be monitored for improvement in depressive symptoms during and after the treatment course, and important considerations include avoiding alcohol during treatment, using effective contraception, and being aware of potential side effects such as drowsiness, dizziness, and sedation.

Treatment of Insomnia and Sleep Disorders

• The provided evidence suggests that eszopiclone, zolpidem, and suvorexant may improve short-term global and sleep outcomes for adults with insomnia disorder, but the comparative effectiveness and long-term efficacy of pharmacotherapies for insomnia are not known 1.
• Other medications such as benzodiazepine hypnotics, melatonin agonists, and antidepressants may also be used to treat insomnia and sleep disorders, but the evidence for these medications is insufficient or low strength 1.

From the FDA Drug Label

The efficacy of ZURZUVAE for the treatment of postpartum depression (PPD) in adults was demonstrated in two randomized, placebo-controlled, double-blind, multicenter studies (Study 1, NCT04442503 and Study 2, NCT02978326) in women with PPD who met the Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode (DSM-5) with onset of symptoms in the third trimester or within 4 weeks of delivery.

Zuranolone is prescribed for the treatment of postpartum depression (PPD) in adults. The medication is indicated for women who meet the Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode (DSM-5) with onset of symptoms in the third trimester or within 4 weeks of delivery.

• The dosage of Zuranolone is 50 mg once daily for 14 days, with the option to reduce the dosage based on tolerability to 40 mg once daily.
• Patients can be treated with Zuranolone even if they are taking a stable dose of oral antidepressant for at least 30 days before baseline 2, 2, 2.

From the Research

Indications for Zuranolone

• Zuranolone is prescribed for the treatment of adults with major depressive disorder (MDD) 3, 4, 5, 6, 7
• It is also approved for the treatment of postpartum depression 5

Patient Selection

• Patients 18-64 years of age with severe MDD may be considered for zuranolone treatment 3
• Patients with MDD who have not responded to standard-of-care antidepressant therapies may also be considered for zuranolone treatment 4

Dosage and Administration

• Zuranolone is administered as a once-daily oral dose of 50 mg for 14 days 3, 4
• It can be co-initiated with standard-of-care antidepressant therapies 4

Efficacy

• Zuranolone has been shown to significantly improve depressive symptoms in adults with MDD, with a rapid time to effect (day 3) 3, 4
• It has also been shown to be effective in improving depressive symptoms in patients with MDD who have not responded to standard-of-care antidepressant therapies 4

Safety and Tolerability

• Zuranolone is generally well tolerated, with the most common adverse events being somnolence, dizziness, headache, and nausea 3, 4, 5
• The majority of patients who experienced adverse events reported mild or moderate events 3, 4, 5