What are the FDA‑approved indications for Zoloft (sertraline)?

Zoloft FDA-Approved Indications

Zoloft (sertraline) is FDA-approved for six psychiatric conditions: major depressive disorder (MDD), obsessive-compulsive disorder (OCD), panic disorder (PD), posttraumatic stress disorder (PTSD), social anxiety disorder (SAD), and premenstrual dysphoric disorder (PMDD). 1

Complete List of FDA Indications

The FDA has approved Zoloft for the following conditions 1:

• Major Depressive Disorder (MDD) – For adults, with initial dosing at 50 mg daily, therapeutic range 50-200 mg daily 1

• Obsessive-Compulsive Disorder (OCD) – Approved for both adults and pediatric patients:

  • Ages 6-12 years: Start 25 mg daily, therapeutic range 50-200 mg daily 1
  • Ages 13-17 years and adults: Start 50 mg daily, therapeutic range 50-200 mg daily 1

• Panic Disorder (PD) – For adults, with initial dosing at 25 mg daily, increasing to 50 mg after one week, maximum 200 mg daily 1

• Posttraumatic Stress Disorder (PTSD) – For adults, with initial dosing at 25 mg daily, increasing to 50 mg after one week, maximum 200 mg daily 1

• Social Anxiety Disorder (SAD) – For adults, with initial dosing at 25 mg daily, increasing to 50 mg after one week, maximum 200 mg daily 1

• Premenstrual Dysphoric Disorder (PMDD) – For adult women only, with two dosing options 1:

  • Continuous dosing: 50 mg daily throughout menstrual cycle, may increase to 150 mg daily
  • Intermittent dosing: Starting 14 days before menses, 50 mg daily (or 50 mg for 3 days then 100 mg for remaining days), maximum 100 mg daily

Critical Safety Information

All patients receiving Zoloft must be monitored for suicidal thoughts and behaviors, particularly in pediatric and young adult patients, as antidepressants carry an FDA black box warning for increased risk of suicidality in these age groups. 1 Close monitoring is especially important during the first months of treatment and following dosage adjustments 2

Dosing Considerations

• Dose adjustments should occur at one-week intervals minimum, given sertraline's 24-hour elimination half-life 1
• Patients with mild hepatic impairment require half the standard dose 1
• Moderate to severe hepatic impairment is a contraindication to use 1
• At least 14 days must elapse when switching to or from MAOI antidepressants 1