Zoloft

Zoloft (sertraline HCl) is a selective serotonin reuptake inhibitor (SSRI) approved by the FDA for the treatment of major depressive disorder (MDD), obsessive-compulsive disorder (OCD), panic disorder, posttraumatic stress disorder (PTSD), social anxiety disorder, and premenstrual dysphoric disorder (PMDD). As a first-line pharmacological intervention, it functions by increasing serotonin activity in the central nervous system, which is instrumental in regulating mood, emotion, and anxiety. Its well-established efficacy, extensive clinical history, and generally favorable tolerability profile make it a cornerstone in modern psychopharmacology. This product card provides a comprehensive overview for healthcare professionals considering Zoloft for their patients.

Features

• Active Pharmaceutical Ingredient: Sertraline Hydrochloride
• Available Dosage Forms: Oral tablets (25 mg, 50 mg, 100 mg) and oral concentrate (20 mg/mL)
• Pharmacologic Class: Selective Serotonin Reuptake Inhibitor (SSRI)
• FDA-approved for multiple psychiatric indications
• Bioavailability: Approximately 44% following oral administration
• Time to Peak Plasma Concentration: 4.5 to 8.4 hours post-dose
• Half-life: Approximately 26 hours
• Metabolism: Hepatic, primarily via CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A4
• Excretion: Urinary and fecal

Benefits

• Demonstrates significant improvement in Montgomery-Åsberg Depression Rating Scale (MADRS) scores in patients with MDD.
• Reduces the frequency and intensity of obsessive thoughts and compulsive behaviors in OCD.
• Effective in decreasing the incidence of panic attacks and anticipatory anxiety.
• Alleviates symptoms of social anxiety, including fear and avoidance of social situations.
• Provides relief from the severe emotional and physical symptoms associated with PMDD.
• Generally well-tolerated with a lower incidence of anticholinergic and cardiovascular side effects compared to older antidepressants.

Common use

Zoloft is primarily prescribed for the management of major depressive disorder, characterized by persistent low mood, anhedonia, changes in sleep or appetite, low energy, poor concentration, and feelings of worthlessness. It is also widely used for obsessive-compulsive disorder, helping to reduce the cycle of intrusive thoughts and repetitive behaviors. Clinicians frequently employ it for panic disorder, where it reduces the frequency of unexpected panic attacks and phobic avoidance. Its application extends to posttraumatic stress disorder, mitigating symptoms like re-experiencing, avoidance, and hyperarousal. Furthermore, it is indicated for social anxiety disorder and the more severe form of premenstrual syndrome known as premenstrual dysphoric disorder.

Dosage and direction

Dosage must be individualized based on the patient’s condition and response. For major depressive disorder and OCD, the recommended starting dose for adults is 50 mg once daily, which may be increased in increments of 50 mg at intervals of no less than one week, depending on therapeutic response and tolerability. The maximum recommended dose is 200 mg/day. For panic disorder, PTSD, and social anxiety disorder, therapy should be initiated at 25 mg once daily to minimize the potential for initial agitation or anxiety, with an increase to 50 mg after one week. The oral concentrate must be diluted before administration; it can be mixed with 4 oz (½ cup) of water, ginger ale, lemon/lime soda, lemonade, or orange juice only. Doses are typically administered once daily, either in the morning or evening, with or without food, though consistency is advised.

Precautions

Patients should be monitored closely for clinical worsening, suicidality, or unusual changes in behavior, particularly during the initial few months of therapy or following dosage changes. Zoloft carries a Black Box Warning regarding this increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults. Use with caution in patients with a history of seizures. SSRIs like Zoloft can impair platelet aggregation and may increase the risk of bleeding, especially when used concomitantly with NSAIDs, aspirin, or other drugs that affect coagulation. Caution is advised in patients with hepatic impairment; a lower or less frequent dose should be considered. Discontinuation of treatment should involve a gradual taper of the dose to avoid withdrawal symptoms such as dizziness, sensory disturbances, agitation, anxiety, nausea, and sweating. Activation of mania/hypomania can occur in patients with bipolar disorder; screen patients for bipolar disorder prior to initiating treatment.

Contraindications

Zoloft is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping an MAOI due to the risk of serotonin syndrome. A 14-day washout period must elapse after stopping Zoloft before initiating an MAOI. It is also contraindicated in patients taking pimozide due to the potential for QT prolongation. Concomitant use with disulfiram is contraindicated when using the oral concentrate formulation because it contains alcohol. Hypersensitivity to sertraline or any component of the formulation is an absolute contraindication.

Possible side effect

The most commonly observed adverse reactions (incidence ≥5% and at least twice that of placebo) include nausea, diarrhea/loose stools, insomnia, somnolence, dry mouth, increased sweating, dizziness, fatigue, tremor, indigestion, decreased appetite, and sexual dysfunction (including decreased libido, ejaculatory delay, and anorgasmia). Other potential side effects include serotonin syndrome (agitation, hallucinations, coma, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea), hyponatremia (especially in elderly patients or those on diuretics), angle-closure glaucoma, and QT interval prolongation. Any unusual symptoms should be reported to a healthcare provider immediately.

Drug interaction

Zoloft has a significant potential for drug interactions due to its metabolism by multiple CYP450 enzymes and its serotonergic activity. Concomitant use with other serotonergic drugs (e.g., other SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, tramadol, tryptophan, buspirone, and St. John’s Wort) increases the risk of serotonin syndrome. Drugs that inhibit CYP2C19 (e.g., cimetidine, fluconazole, fluvoxamine) may increase sertraline plasma levels. Sertraline itself is an inhibitor of CYP2D6 and can increase levels of drugs metabolized by this enzyme, such as tricyclic antidepressants, antipsychotics (e.g., haloperidol, risperidone), and certain beta-blockers (e.g., metoprolol). Concurrent use with drugs that prolong the QT interval (e.g., certain antipsychotics, antibiotics) should be approached with caution. It can increase the anticoagulant effect of warfarin, requiring close monitoring of INR.

Missed dose

If a dose is missed, it should be taken as soon as the patient remembers. However, if it is almost time for the next scheduled dose, the missed dose should be skipped, and the regular dosing schedule resumed. Patients should not take a double dose to make up for a missed one, as this increases the risk of adverse effects.

Overdose

Symptoms of overdose (singly or in combination with other drugs) may include serotonin syndrome, somnolence, nausea, vomiting, tachycardia, dizziness, agitation, tremor, and dilated pupils. In severe cases, unconsciousness or ECG changes may occur. There is no specific antidote for sertraline overdose. Management involves establishing and maintaining an airway and ensuring adequate oxygenation and ventilation. Gastric lavage with a protected airway may be considered if performed soon after ingestion. Activated charcoal may be administered. Cardiac and vital sign monitoring is recommended, along with general symptomatic and supportive measures.

Storage

Store Zoloft tablets and oral concentrate at room temperature, 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep the bottle tightly closed to protect from moisture and light. The oral concentrate must be stored in the original bottle; once diluted, the dose must be taken immediately. Keep all medications out of the reach of children and pets.

Disclaimer

This information is intended for educational purposes and healthcare professionals. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The content is based on the manufacturer’s prescribing information but may not encompass all data, uses, precautions, or interactions.

Reviews

(Note: As a prescription medication, reviews are aggregated from clinical literature and post-marketing surveillance rather than consumer websites.)

Zoloft is consistently reviewed in clinical literature as a highly effective and generally well-tolerated SSRI. A meta-analysis published in The Lancet reviewing 21 antidepressants found sertraline to be among the most efficacious and acceptable treatments for the acute-phase treatment of adults with major depressive disorder. Its broad spectrum of indications makes it a versatile tool in psychiatry. Post-marketing surveillance and decades of clinical use have solidified its safety profile, though vigilance for the Black Box Warning regarding suicidality in young adults remains paramount. Common points noted in clinical practice include its effectiveness in reducing anxiety components of depression and its relatively lower weight gain potential compared to some other antidepressants. The side effect profile, particularly initial nausea and sexual dysfunction, is frequently cited as a reason for discontinuation in a minority of patients, though many adverse effects are transient.