Zoloft (Sertraline): A Guide to Its Uses and Evidence

What is Zoloft (Sertraline)?

Zoloft, known generically as sertraline, is a selective serotonin reuptake inhibitor SSRI commonly prescribed to treat a variety of mental health disorders. It works by increasing the amount of serotonin, a natural substance in the brain that helps with various mental health disorders.

FDA-Approved Uses and Patient Benefits:

Zoloft is FDA-approved for the treatment of the following conditions:

Clinical trials have shown that approximately 50-70% of patients with these conditions experience a significant reduction in symptoms when treated with Zoloft.

Off-Label Benefits Backed by Research:

In addition to its FDA-approved uses, Zoloft has been used off-label for conditions such as:

  • Generalized Anxiety Disorder (GAD)

  • Body Dysmorphic Disorder (BDD)

  • Major Depressive Disorder during Pregnancy 

  • Major Depressive Disorder while Breastfeeding

Dosing Information:

Here is a consolidated list of starting and maximum dosages for Zoloft (Sertraline) for each disorder:

  • Major Depressive Disorder (MDD): Starting dose is 50 mg per day, with a maximum dose of 200 mg per day.

  • Obsessive-Compulsive Disorder (OCD):

    • For ages 6-12, the starting dose is 25 mg per day, with a maximum dose of 200 mg per day.

    • For ages 13 and above, the starting dose is 50 mg per day, with a maximum dose of 400 mg per day.

  • Panic Disorder (PD), Post-Traumatic Stress Disorder (PTSD), Social Anxiety Disorder (SAD), Generalized Anxiety Disorder (GAD): Starting dose is 25 mg per day, with a maximum dose of 200 mg per day.

  • Premenstrual Dysphoric Disorder (PMDD) - Continuous Dosing: Starting dose is 50 mg per day, with a maximum dose of 150 mg per day.

  • Premenstrual Dysphoric Disorder (PMDD) - Intermittent Dosing: Starting dose is 50 mg per day during the luteal phase only, with a maximum dose of 100 mg per day during the luteal phase only.

  • Body Dysmorphic Disorder (BDD)

    • For ages 6-12, the starting dose is 25 mg per day, with a maximum dose of 200 mg per day.

    • For ages 13 and above, the starting dose is 50 mg per day, with a maximum dose of 400 mg per day.

It is important to follow your healthcare provider's instructions for dosing, as they will tailor it to your specific needs.

Optimal Timing for Taking Zoloft:

Zoloft can be taken with or without food, any time of day. It is generally recommended to take it at the same time each day to maintain an even level in your system.

Potential Side Effects:

These side effects range from mild, often improving over time, to severe, which may require immediate medical attention. Zoloft is among the most well-tolerated SSRIs, and the least likely to cause weight gain. It is also considered one of the safest for use during pregnancy and breastfeeding.

Here is a list of the top 15 side effects of Zoloft (sertraline), ordered from most to least common based on the provided sources:

  • Nausea: If you experience an upset stomach, taking it with food may help.

  • Diarrhea/Loose stool 

  • Insomnia 

  • Dizziness 

  • Tiredness or Sleepiness 

  • Sexual Dysfunction: Includes problems such as decreased libido, delayed orgasm, and erectile dysfunction.

  • Sweating 

  • Tremors 

  • Reduced Appetite

  • Dry Mouth 

  • Headaches 

  • Weight Changes: Includes both weight gain and weight loss, noted in some patients.

  • Increased Risk of Bleeding: Particularly when taken with other medications like NSAIDs or in patients with clotting disorders such as hemophilia or von Willebrand disease.

  • Serotonin Syndrome: A serious but less common side effect.

Black Box Warning for Patients Under 24 Years of Age:

The black box warning for Zoloft and other antidepressants highlights a small but increased risk of suicidal thoughts and behaviors in individuals aged 24 and younger when used to treat major depressive disorder and other mental health conditions, with the incidence being roughly 1 in 132 in this age group.

Potential Contraindications:

Patients should not take Zoloft if they are taking monoamine oxidase inhibitors (MAOIs), pimozide, or are allergic to sertraline. It is also advised to minimize alcohol use while taking Zoloft, as some patients notice a change in their tolerance. Patients who are pregnant, breast feeding, or have a history of seizures, liver, kidney, or heart disease should consult their healthcare provider before starting Zoloft. 

Citations:

  1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839s74s86

    s87_20990s35s44s45lbl.pdf

  2. https://www.urmc.rochester.edu/medialibraries/urmcmedia/medicine/gener

  3. al-medicine/patientcare/documents/Sertraline_Brochure.pdf

  4. https://medlineplus.gov/druginfo/meds/a697048.html

  5. https://labeling.pfizer.com/ShowLabeling.aspx?Section=MedGuide&id=517

  6. https://www.zoloft.com/en/Resources

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