Below are the general guidelines for dosing sertraline (Zoloft). Note that these dosages may be adjusted on a case-by-case basis for individual patients. Always follow your prescribing physician’s instructions for taking sertraline (Zoloft).
The following information comes from DailyMed, an FDA label information provider.
What if I miss a dose of sertraline?
According to Mayo Clinic, if you miss a dose of sertraline, take it as soon as possible unless you are closer in time to your next dose. If the latter is true, wait until your next dose. Never double doses.
What if I overdose on sertraline?
Human Experience
Of 1,027 cases of overdose involving sertraline hydrochloride worldwide, alone or with other drugs, there were 72 deaths (circa 1999).
Among 634 overdoses in which sertraline hydrochloride was the only drug ingested, 8 resulted in fatal outcome, 75 completely recovered, and 27 patients experienced sequelae after overdosage to include alopecia, decreased libido, diarrhea, ejaculation disorder, fatigue, insomnia, somnolence and serotonin syndrome. The remaining 524 cases had an unknown outcome. The most common signs and symptoms associated with non-fatal sertraline hydrochloride overdosage were somnolence, vomiting, tachycardia, nausea, dizziness, agitation and tremor.
The largest known ingestion was 13.5 grams in a patient who took sertraline hydrochloride alone and subsequently recovered. However, another patient who took 2.5 grams of sertraline hydrochloride alone experienced a fatal outcome.
Other important adverse events reported with sertraline hydrochloride overdose (single or multiple drugs) include bradycardia, bundle branch block, coma, convulsions, delirium, hallucinations, hypertension, hypotension, manic reaction, pancreatitis, QT-interval prolongation, serotonin syndrome, stupor and syncope.
Overdose Management
Treatment should consist of those general measures employed in the management of overdosage with any antidepressant.
Ensure an adequate airway, oxygenation and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion, or in symptomatic patients.
Activated charcoal should be administered. Due to large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. No specific antidotes for sertraline are known.
In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center on the treatment of any overdose. Telephone numbers for certified poison control centers are listed in the Physicians’ Desk Reference® (PDR®).
Dosage and Administration
Initial Treatment
Dosage for Adults
Major Depressive Disorder and Obsessive-Compulsive Disorder
Sertraline treatment should be administered at a dose of 50 mg once daily.
Panic Disorder, Posttraumatic Stress Disorder and Social Anxiety Disorder
Sertraline treatment should be initiated with a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily.
While a relationship between dose and effect has not been established for major depressive disorder, OCD, panic disorder, PTSD or social anxiety disorder, patients were dosed in a range of 50-200 mg/day in the clinical trials demonstrating the effectiveness of Sertraline for the treatment of these indications. Consequently, a dose of 50 mg, administered once daily, is recommended as the initial therapeutic dose. Patients not responding to a 50 mg dose may benefit from dose increases up to a maximum of 200 mg/day. Given the 24 hour elimination half-life of Sertraline, dose changes should not occur at intervals of less than 1 week.
Premenstrual Dysphoric Disorder
Sertraline treatment should be initiated with a dose of 50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment.
While a relationship between dose and effect has not been established for PMDD, patients were dosed in the range of 50-150 mg/day with dose increases at the onset of each new menstrual cycle (see CLINICAL TRIALS UNDER CLINICAL PHARMACOLOGY). Patients not responding to a 50 mg/day dose may benefit from dose increases (at 50 mg increments/menstrual cycle) up to 150 mg/day when dosing daily throughout the menstrual cycle, or 100 mg/day when dosing during the luteal phase of the menstrual cycle. If a 100 mg/day dose has been established with luteal phase dosing, a 50 mg/day titration step for three days should be utilized at the beginning of each luteal phase dosing period.
Sertraline should be administered once daily, either in the morning or evening.
Dosage for Pediatric Population (Children and Adolescents)
Obsessive-Compulsive Disorder
Sertraline treatment should be initiated with a dose of 25 mg once daily in children (ages 6-12) and at a dose of 50 mg once daily in adolescents (ages 13-17).
While a relationship between dose and effect has not been established for OCD, patients were dosed in a range of 25-200 mg/day in the clinical trials demonstrating the effectiveness of Sertraline for pediatric patients (6-17 years) with OCD. Patients not responding to an initial dose of 25 or 50 mg/day may benefit from dose increases up to a maximum of 200 mg/day. For children with OCD, their generally lower body weights compared to adults should be taken into consideration in advancing the dose, in order to avoid excess dosing. Given the 24 hour elimination half-life of ZOLOFT, dose changes should not occur at intervals of less than 1 week.
Sertraline should be administered once daily, either in the morning or evening.
Maintenance/Continuation/Extended Treatment
Major Depressive Disorder
It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy beyond response to the acute episode. Systematic evaluation of Sertraline has demonstrated that its antidepressant efficacy is maintained for periods of up to 44 weeks following 8 weeks of initial treatment at a dose of 50-200 mg/day (mean dose of 70 mg/day) (see CLINICAL TRIALS UNDER CLINICAL PHARMACOLOGY). It is not known whether the dose of Sertraline needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment.
Posttraumatic Stress Disorder
It is generally agreed that PTSD requires several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of Sertraline has demonstrated that its efficacy in PTSD is maintained for periods of up to 28 weeks following 24 weeks of treatment at a dose of 50-200 mg/day (see CLINICAL TRIALS UNDER CLINICAL PHARMACOLOGY). It is not known whether the dose of Sertraline needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment.
Social Anxiety Disorder
Social anxiety disorder is a chronic condition that may require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of Sertraline has demonstrated that its efficacy in social anxiety disorder is maintained for periods of up to 24 weeks following 20 weeks of treatment at a dose of 50-200 mg/day (see CLINICAL TRIALS UNDER CLINICAL PHARMACOLOGY). Dosage adjustments should be made to maintain patients on the lowest effective dose and patients should be periodically reassessed to determine the need for long-term treatment.
Obsessive-Compulsive Disorder and Panic Disorder
It is generally agreed that OCD and Panic Disorder require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of continuing Sertraline for periods of up to 28 weeks in patients with OCD and Panic Disorder who have responded while taking Sertraline during initial treatment phases of 24 to 52 weeks of treatment at a dose range of 50-200 mg/day has demonstrated a benefit of such maintenance treatment (see CLINICAL TRIALS UNDER CLINICAL PHARMACOLOGY). It is not known whether the dose of Sertraline needed for maintenance treatment is identical to the dose needed to achieve an initial response. Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.
Premenstrual Dysphoric Disorder
The effectiveness of Sertraline in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. However, as women commonly report that symptoms worsen with age until relieved by the onset of menopause, it is reasonable to consider continuation of a responding patient. Dosage adjustments, which may include changes between dosage regimens (e.g., daily throughout the menstrual cycle versus during the luteal phase of the menstrual cycle), may be needed to maintain the patient on the lowest effective dosage and patients should be periodically reassessed to determine the need for continued treatment.
Switching Patients to or from a Monoamine Oxidase Inhibitor
At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with Sertraline. In addition, at least 14 days should be allowed after stopping Sertraline before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).
Special Populations
Dosage for Hepatically Impaired Patients
The use of sertraline in patients with liver disease should be approached with caution. The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied. If sertraline is administered to patients with liver impairment, a lower or less frequent dose should be used (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
Treatment of Pregnant Women During the Third Trimester
Neonates exposed to Sertraline and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with Sertraline during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering Sertraline in the third trimester.
Discontinuation of Treatment with Zoloft
Symptoms associated with discontinuation of Sertraline and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
Sertraline Oral Concentrate
Sertraline Oral Concentrate contains 20 mg/mL of sertraline (as the hydrochloride) as the active ingredient and 12% alcohol. Sertraline Oral Concentrate must be diluted before use. Just before taking, use the dropper provided to remove the required amount of Sertraline Oral Concentrate and mix with 4 oz (1/2 cup) of water, ginger ale, lemon/lime soda, lemonade or orange juice ONLY. Do not mix Sertraline Oral Concentrate with anything other than the liquids listed. The dose should be taken immediately after mixing. Do not mix in advance. At times, a slight haze may appear after mixing; this is normal. Note that caution should be exercised for patients with latex sensitivity, as the dropper dispenser contains dry natural rubber.
Sertraline Oral Concentrate is contraindicated with ANTABUSE (disulfiram) due to the alcohol content of the concentrate.
How is sertraline supplied?
ZOLOFT (sertraline hydrochloride) capsular-shaped scored tablets, containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline, are packaged in bottles.
ZOLOFT 25 mg Tablets: light green film coated tablets engraved on one side with ZOLOFT and on the other side scored and engraved with 25 mg.
NDC 0049-4960-30 Bottles of 30
NDC 0049-4960-50 Bottles of 50
ZOLOFT 50 mg Tablets: light blue film coated tablets engraved on one side with ZOLOFT and on the other side scored and engraved with 50 mg.
NDC 0049-4900-30 Bottles of 30
NDC 0049-4900-66 Bottles of 100
NDC 0049-4900-73 Bottles of 500
NDC 0049-4900-94 Bottles of 5000
NDC 0049-4900-41 Unit Dose Packages of 100
ZOLOFT 100 mg Tablets: light yellow film coated tablets engraved on one side with ZOLOFT and on the other side scored and engraved with 100 mg.
NDC 0049-4910-30 Bottles of 30
NDC 0049-4910-66 Bottles of 100
NDC 0049-4910-73 Bottles of 500
NDC 0049-4910-94 Bottles of 5000
NDC 0049-4910-41 Unit Dose Packages of 100
Store at 25°C (77°F); excursions permitted to 15° – 30°C (59° – 86°F)[see USP Controlled Room Temperature].
ZOLOFT Oral Concentrate: ZOLOFT Oral Concentrate is a clear, colorless solution with a menthol scent containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL and 12% alcohol. It is supplied as a 60 mL bottle with an accompanying calibrated dropper.
NDC 0049-4940-23 Bottles of 60 mL
Store at 25°C (77°F); excursions permitted to 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature].
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