Sertraline

In adults, Zoloft is labeled for major depressive disorder (MDD), obsessive-compulsive disorder (OCD), panic disorder, posttraumatic stress disorder (PTSD), social anxiety disorder, and premenstrual dysphoric disorder (PMDD).

For children and adolescents aged 6–17 years, OCD is the established labeled indication. Pediatric depression and other pediatric indications are not established in this label. This profile does not provide an exhaustive off-label prescribing guide.

For inadequate response, increase by 25–50 mg daily no more often than once weekly according to tolerability, up to 200 mg daily. Tablets may be taken with or without food. The concentrate requires dilution.

Start 50 mg daily in adult women. Continuous treatment: increase in 50 mg increments per menstrual cycle if needed, to a maximum 150 mg daily.

Intermittent treatment: dose during the luteal phase, starting 14 days before anticipated menstruation and continuing through the onset of menses. If 50 mg is inadequate, the next cycle may use 50 mg daily for the first 3 dosing days, then 100 mg daily for the remaining dosing days; maximum 100 mg daily.

Mild hepatic impairment (Child-Pugh 5–6): use half the usual starting dose and half the therapeutic range. Use is not recommended in moderate or severe hepatic impairment. No dose adjustment is needed for mild to severe renal impairment.

Dilute before use. Measure with the supplied calibrated dropper (marked only at 25 mg and 50 mg); confirm an appropriate measuring plan for other prescribed doses. Mix the dose with 4 ounces (½ cup) of water, ginger ale, lemon/lime soda, lemonade, or orange juice only. Take immediately; do not premix. Slight haze after dilution is normal.

The concentrate contains 12% alcohol and is contraindicated with disulfiram. The dropper contains dry natural rubber; review latex sensitivity. Directions do not apply automatically to other sertraline liquids or capsule products.

Screen for personal or family history of bipolar disorder before starting. Allow at least 14 days after stopping an MAOI antidepressant before starting sertraline, and at least 14 days after stopping sertraline before starting an MAOI antidepressant.

Reduce gradually when stopping whenever possible. The taper depends on clinical response and withdrawal symptoms; do not abruptly stop on your own.

Concomitant MAOIs, including linezolid or intravenous methylene blue, or use within the MAOI washout interval; pimozide; and known sertraline hypersensitivity. Observe the 14-day separation for MAOI antidepressant switches.

Disulfiram is additionally contraindicated with the alcohol-containing Zoloft oral concentrate; this formulation-specific restriction is not a tablet alcohol-content claim.

Antidepressants increased suicidal thoughts and behavior in pediatric and young adult patients in short-term trials. Closely monitor all patients for worsening illness or emerging suicidality, particularly in the first months and during dose changes. Educate caregivers to report concerning behavior promptly; emergency danger requires emergency care.

Common trial events included nausea, diarrhea, tremor, indigestion, decreased appetite, sweating, ejaculation failure, and reduced libido. Sleep disturbance, fatigue, or agitation can also occur. Trial rates cannot be used as direct comparisons with other antidepressants.

Serious reported reactions include serotonin syndrome, major bleeding, severe hyponatremia, arrhythmias, hypersensitivity, and severe skin or liver events. Postmarketing frequencies are uncertain.

Highly protein-bound drugs may require monitoring and dose adjustment for adverse effects. Oral concentrate plus disulfiram is contraindicated because of alcohol.

Benzodiazepine urine immunoassays may be falsely positive during treatment and for several days after stopping. Confirmatory testing can distinguish sertraline from benzodiazepines.

Consider relapse and untreated-illness risks alongside treatment risks. Overall epidemiologic data do not show a difference in major birth-defect risk with first-trimester sertraline compared with comparator background rates; individual defect findings are inconclusive.

Late-pregnancy SSRI exposure can be associated with neonatal adaptation or discontinuation symptoms and persistent pulmonary hypertension; monitor exposed newborns. Use close to delivery may increase postpartum hemorrhage risk. The 12%-alcohol Zoloft concentrate is not recommended during pregnancy; review a suitable formulation with the clinician. The label lists an antidepressant pregnancy registry.

Published data show low sertraline and metabolite levels in human milk. Effects on milk production are unknown. Consider breastfeeding benefits, maternal treatment need, and possible infant effects together.

Pediatric approval is for OCD at ages 6–17 only. Monitor growth, weight, appetite, behavior, and suicidality during pediatric treatment.

Older adults warrant conservative dose selection and particular attention to hyponatremia, organ function, and interacting medicines.

Enhances central serotonergic activity by inhibiting neuronal serotonin reuptake. It also inhibits serotonin uptake by platelets, relevant to bleeding risk. It does not inhibit monoamine oxidase.

Absorption

Peak plasma concentration about 4.5–8.4 hours after repeated oral dosing.

Half-life / steady state

Parent drug about 26 hours; steady state after about 1 week.

Metabolism

Extensive hepatic first-pass metabolism; N-desmethylsertraline is substantially less active.

Protein binding / elimination

About 98% protein bound; radiolabeled metabolites recovered in urine and feces, with negligible unchanged urinary drug.

• Assess indication-specific symptom response, adherence, and adverse effects; screen bipolar history before starting.
• Monitor worsening depression, suicidality, unusual behavior, and mania, especially during early treatment or dose changes.
• Evaluate suspected serotonin syndrome, bleeding, or symptomatic hyponatremia promptly. Consider sodium assessment when risk or symptoms warrant it.
• Monitor pediatric growth and weight; ask directly about sexual adverse effects.
• Check INR with warfarin and phenytoin concentrations as indicated; review hepatic function and cardiac-risk context.

• Take the prescribed once-daily dose. If a dose is missed, take it when remembered unless nearly time for the next; do not double.
• Do not abruptly stop. Contact the prescriber for a taper or troublesome adverse effects.
• Review all medicines and supplements, including pain relievers and St. John’s wort; avoid alcohol.
• Do not drive or operate hazardous machinery until the effect on alertness is known.
• Dilute the concentrate only with the specified liquids and take immediately. Review latex sensitivity and disulfiram use.
• Report suicidal thoughts, marked mood changes, severe rash, eye pain or visual changes, or signs of serotonin syndrome urgently.
• For overdose, contact U.S. Poison Control at 1-800-222-1222 or seek emergency assessment.

Other manufacturers and formulations differ. Confirm the imprint and original packaging with a pharmacist.

Dosage form / strength

Film-coated scored tablet · 50 mg

Label distributor

Viatris Specialty LLC

Appearance

Light blue, capsular-shaped tablet

Imprint

ZOLOFT on one side · 50 mg on the scored side

Example package NDC

58151-575-93 · 30 tablets

Zoloft tablets

25, 50, 100 mg

Zoloft oral concentrate

20 mg/mL; 60 mL bottle; 12% alcohol; dilute before use

Other products

Generic tablets, other liquids, and capsule products require their own labels and instructions.

Store Zoloft at 20–25°C (68–77°F); excursions 15–30°C (59–86°F) are permitted. Keep the bottle tightly closed and medicines out of children’s reach. Mix the oral concentrate only immediately before the dose.