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Zoloft (sertraline)
Selective serotonin reuptake inhibitor (SSRI) that blocks the serotonin transporter, increasing synaptic serotonin to improve mood and reduce anxiety.
Sertraline is an SSRI indicated for major depressive disorder, obsessive-compulsive disorder, and panic disorder in adults. It demonstrates linear dose-proportional pharmacokinetics with a 26-hour half-life and achieves steady-state after approximately one week of once-daily dosing. Major contraindications include concurrent or recent MAOI use due to serotonin syndrome risk, and caution is warranted with protein-bound drugs like warfarin due to potential displacement interactions. The drug undergoes extensive hepatic metabolism with significant accumulation of active metabolites, requiring careful monitoring in patients on interacting medications.
At a glance
| Generic name | sertraline |
|---|---|
| Also known as | Zoloft, Lustral |
| Sponsor | Pfizer Inc. |
| Drug class | SSRI (Selective serotonin reuptake inhibitor) |
| Target | Cytochrome P450 2C19, Melanocortin receptor 5, 5-hydroxytryptamine receptor 2A |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1991-12-30 (United States) |
| Annual revenue | 350 |
Mechanism of action
Sertraline selectively inhibits the reuptake of serotonin at the presynaptic membrane, increasing serotonin availability in the synaptic cleft. It was developed by Pfizer and became one of the most prescribed antidepressants worldwide (as Zoloft). It has the broadest FDA-approved indication profile of any SSRI, including depression, OCD, PTSD, panic disorder, social anxiety disorder, and PMDD.
Approved indications
- Depressive disorder
- Obsessive-compulsive disorder
- Panic disorder
- Posttraumatic stress disorder
- Premenstrual dysphoric disorder
- Social phobia
Common side effects
- Nausea
- Diarrhea/loose stool
- Tremor
- Dyspepsia
- Decreased appetite
- Hyperhidrosis
- Ejaculation failure
- Decreased libido
- Erectile dysfunction
- Ejaculation disorder
- Male sexual dysfunction
- Fever
Serious adverse events
- Serotonin syndrome
Drug interactions
- Warfarin
- Digitoxin
- Cimetidine
- Diazepam
Key clinical trials
- The Efficacy of Statins in Management of Major Depression Disorder (MDD) Among Adult Patients Attending the Outpatient Clinics of El Demerdash Hospital. (Phase 3)
- Assessing Tolerability and Efficacy of Vortioxetine Versus SSRIs in Elderly Patients With Depression: a Pragmatic, Multicenter, Open-label, Parallel-group, Superiority, Randomized Trial (Phase 4)
- Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) Therapy Versus Selective Serotonin Reuptake Inhibitors (SSRIs) in the Treatment of Post-Traumatic Stress Disorder: A Randomized Control (NA)
- Effects and Consequences for Mother and Child From Treatment for Depression, A Prospective Randomized, Placebo- Controlled, Trial With Internet-based Cognitive Behavior Therapy and Sertraline or Place (Phase 4)
- A PHASE IV, SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSSOVER STUDY TO DETERMINE THE RELATIVE BIOAVAILABILITY OF ZOLOFT (REGISTERED) ORAL SOLUTION (20 MG/ML; FARMASIERRA MANUFACTURING, S.L.) COMPAR (Phase 4)
- Electroretinogram (ERG) as a Potential Biomarker of Serotonin Selective Reuptake Inhibitor (SSRI)-Responsive Posttraumatic Stress Disorder (PTSD): A Pilot Study (NA)
- Sertraline and Cognitive Therapy in Depressed Alcoholics (Phase 2)
- Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Zoloft CI brief — competitive landscape report
- Zoloft updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI