Maximum Recommended Dose of Sertraline
The maximum recommended dose of sertraline is 200 mg per day for adults across all approved indications. 1
Dosing Guidelines for Adults
- The FDA-approved maximum dosage for sertraline in adults is 200 mg daily for major depressive disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, and social anxiety disorder 1
- For premenstrual dysphoric disorder (PMDD), the maximum dose is 150 mg/day when dosing daily throughout the menstrual cycle, or 100 mg/day when dosing during the luteal phase 1
- Dose changes should not occur at intervals of less than 1 week due to sertraline's 24-hour elimination half-life 1
Initial Dosing and Titration
- For major depressive disorder and obsessive-compulsive disorder, treatment should be initiated at 50 mg once daily 1
- For panic disorder, PTSD, and social anxiety disorder, treatment should begin at 25 mg once daily for one week, then increase to 50 mg once daily 1
- Patients not responding to a 50 mg dose may benefit from dose increases up to the maximum of 200 mg/day 1
- Dose increases should be made in 50 mg increments at intervals of at least one week 1, 2
Dosing Considerations
- The starting dose of 50 mg/day is considered the usually effective therapeutic dose and optimal dose for most patients when considering both efficacy and tolerability 2
- Sertraline can be administered once daily at any time of day, either morning or evening 1
- Unlike some other SSRIs, there is no need for altered dose recommendations in elderly patients 2
- Steady-state plasma concentrations vary widely (up to 15-fold) in patients receiving usual antidepressant dosages between 50 and 150 mg/day 3
Special Populations
- For children with OCD (ages 6-12), treatment should be initiated at 25 mg once daily 1
- For adolescents with OCD (ages 13-17), treatment should be initiated at 50 mg once daily 1
- The maximum dose for pediatric patients with OCD is also 200 mg/day 1
- For patients with Alzheimer's disease and depression, the maximum recommended dose remains 200 mg per day 4
Safety Considerations
- Higher doses are associated with increased side effects 5
- Common side effects include sweating, tremors, nervousness, insomnia or somnolence, dizziness, gastrointestinal disturbances, and sexual dysfunction 4
- Sertraline has minimal inhibitory effects on major cytochrome P450 enzymes, resulting in fewer drug-drug interactions compared to other SSRIs 4, 3
- When initiating antidepressant treatment, patients should be monitored closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of therapy or at times of dose changes 6
Clinical Pearls
- A fixed-dose study demonstrated that 50 mg daily is as effective as higher dosages for the treatment of major depression with fewer side effects and therapy discontinuations 5
- Sertraline is generally well tolerated in elderly patients and lacks the marked anticholinergic effects that characterize tricyclic antidepressants 7
- For maintenance treatment of major depressive disorder, the effective dose range is 50 to 200 mg/day (mean dose of 70 mg/day in clinical trials) 1