Generic Name: sertraline (SER tra leen)
Brand Name: Zoloft

What is sertraline?

Sertraline is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Sertraline affects chemicals in the brain that may become unbalanced and cause depression, panic, anxiety, or obsessive-compulsive symptoms.

Sertraline is used to treat depression, obsessive-compulsive disorder, panic disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).

Sertraline may also be used for purposes not listed in this medication guide.

What is the most important information I should know about sertraline?

You should not use sertraline if you also take pimozide, or if you are being treated with methylene blue injection.

Do not use sertraline if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using sertraline. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Do not give sertraline to anyone younger than 18 years old without the advice of a doctor. Sertraline is FDA-approved for children with obsessive-compulsive disorder (OCD). It is not approved for treating depression in children.

What should I discuss with my healthcare provider before taking sertraline?

You should not use sertraline if you are allergic to it, if you also take pimozide, or if you are being treated with methylene blue injection.

Do not use sertraline if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. After you stop taking sertraline, you must wait at least 14 days before you start taking an MAOI.

To make sure sertraline is safe for you, tell your doctor if you have:

• liver or kidney disease;

• seizures or epilepsy;

• a bleeding or blood clotting disorder;

• bipolar disorder (manic depression); or

• a history of drug abuse or suicidal thoughts.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using sertraline. Your family or other caregivers should also be alert to changes in your mood or symptoms.

FDA pregnancy category C. Taking an SSRI antidepressant during pregnancy may cause serious lung problems or other complications in the baby. However, you may have a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant while taking sertraline. Do not start or stop taking this medicine during pregnancy without your doctor's advice.

It is not known whether sertraline passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give sertraline to anyone younger than 18 years old without the advice of a doctor. Sertraline is FDA-approved for children with obsessive-compulsive disorder (OCD). It is not approved for treating depression in children.

How should I take sertraline?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Sertraline may be taken with or without food. Try to take the medicine at the same time each day.

The liquid form of sertraline must be diluted before you take it. To be sure you get the correct dose, measure the liquid with the medicine dropper provided. Mix the dose with 4 ounces (one-half cup) of water, ginger ale, lemon/lime soda, lemonade, or orange juice. Do not use any other liquids to dilute the medicine. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

This medicine can cause you to have a false positive drug screening test. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking sertraline.

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Do not stop using sertraline suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using sertraline.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking sertraline?

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with sertraline may cause you to bruise or bleed easily.

Drinking alcohol can increase certain side effects of sertraline.

Do not take the liquid form of sertraline if you are taking disulfiram (Antabuse). Liquid sertraline may contain alcohol and you could have a severe reaction to the disulfiram.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Sertraline side effects

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;

• agitation, hallucinations, fever, overactive reflexes, tremors;

• nausea, vomiting, diarrhea, loss of appetite, feeling unsteady, loss of coordination; or

• headache, trouble concentrating, memory problems, weakness, fainting, seizure, shallow breathing or breathing that stops.

Common side effects may include:

• drowsiness, dizziness, tired feeling;

• mild nausea, stomach pain, upset stomach, constipation;

• dry mouth;

• changes in appetite or weight;

• sleep problems (insomnia); or

• decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Sertraline dosing information

Usual Adult Dose for Depression:

Initial dose: 50 mg orally once a day
Maintenance Dose: 50 to 200 mg orally once a day

Comments:
-Dose adjustments may be made at intervals of at least one week.
-Obsessive Compulsive Disorder and acute episodes of Major Depressive Disorder require several months or longer of sustained pharmacologic therapy.

Usual Adult Dose for Obsessive Compulsive Disorder:

Initial dose: 50 mg orally once a day
Maintenance Dose: 50 to 200 mg orally once a day

Comments:
-Dose adjustments may be made at intervals of at least one week.
-Obsessive Compulsive Disorder and acute episodes of Major Depressive Disorder require several months or longer of sustained pharmacologic therapy.

Usual Adult Dose for Panic Disorder:

Initial dose: 25 mg orally once a day, increased after one week to 50 mg orally once a day
Maintenance dose: 50 to 200 mg orally once a day

Comments:
-Dose adjustments may be made at intervals of at least one week.
-These conditions generally required several months or longer of sustained pharmacological therapy beyond initial treatment.

Usual Adult Dose for Post Traumatic Stress Disorder:

Initial dose: 25 mg orally once a day, increased after one week to 50 mg orally once a day
Maintenance dose: 50 to 200 mg orally once a day

Comments:
-Dose adjustments may be made at intervals of at least one week.
-These conditions generally required several months or longer of sustained pharmacological therapy beyond initial treatment.

Usual Adult Dose for Social Anxiety Disorder:

Initial dose: 25 mg orally once a day, increased after one week to 50 mg orally once a day
Maintenance dose: 50 to 200 mg orally once a day

Comments:
-Dose adjustments may be made at intervals of at least one week.
-These conditions generally required several months or longer of sustained pharmacological therapy beyond initial treatment.

Usual Adult Dose for Premenstrual Dysphoric Disorder:

Continuous regimen:
Initial dose: 50 mg orally once a day during the menstrual cycle
Maintenance dose: 50 to 150 mg orally once a day during the menstrual cycle

Cyclic regimen:
Initial dose: 50 mg orally once a day starting 14 days prior to the anticipated start of menstruation through to the first full day of menses, and repeated with each new cycle
Maintenance dose: 50 to 100 mg orally once a day

Comments:
-The dose may be increased in increments of 50 mg per menstrual cycle, increased at the onset of each new cycle; dosage adjustments may also include changes between regimens.
-If a 100 mg once daily dose has been established with the cyclic regimen, a titration step of 50 mg per day for three days should be used at the beginning of each dosing period (luteal phase of the menstrual cycle).
-The effectiveness of sertraline for longer than three months has not been systematically evaluated in controlled trials.

Usual Pediatric Dose for Obsessive Compulsive Disorder:

6 to 12 years:
Initial dose: 25 mg orally once a day
Maintenance dose: 25 to 200 mg orally once a day

13 to 17 years:
Initial dose: 50 mg orally once a day
Maintenance dose: 50 to 200 mg orally once a day

Comments:
-The dose may be increased at intervals of at least one week.
-The potential risks versus clinical need should be assessed prior to using this drug in children and adolescents.

What other drugs will affect sertraline?

Taking sertraline with other drugs that make you sleepy or slow your breathing can increase these effects. Ask your doctor before taking sertraline with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with sertraline, especially:

• any other antidepressant;

• buspirone;

• cimetidine;

• digitoxin;

• lithium;

• St. John's wort;

• tryptophan (sometimes called L-tryptophan);

• warfarin, Coumadin;

• cough medicine that contains dextromethorphan;

• heart or blood pressure medication--flecainide, metoprolol, propafenone, propranolol, and others;

• migraine headache medicines--sumatriptan, zolmitriptan, and others;

• pain medication--fentanyl, tramadol; or

• seizure medication--divalproex, phenytoin.

This list is not complete. Other drugs may interact with sertraline, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Usual Adult Dose for Depression

Initial dose: 50 mg orally once a day
Maintenance Dose: 50 to 200 mg orally once a day

Comments:
-Dose adjustments may be made at intervals of at least one week.
-Obsessive Compulsive Disorder and acute episodes of Major Depressive Disorder require several months or longer of sustained pharmacologic therapy.

Usual Adult Dose for Obsessive Compulsive Disorder

Initial dose: 50 mg orally once a day
Maintenance Dose: 50 to 200 mg orally once a day

Comments:
-Dose adjustments may be made at intervals of at least one week.
-Obsessive Compulsive Disorder and acute episodes of Major Depressive Disorder require several months or longer of sustained pharmacologic therapy.

Usual Adult Dose for Panic Disorder

Initial dose: 25 mg orally once a day, increased after one week to 50 mg orally once a day
Maintenance dose: 50 to 200 mg orally once a day

Comments:
-Dose adjustments may be made at intervals of at least one week.
-These conditions generally required several months or longer of sustained pharmacological therapy beyond initial treatment.

Usual Adult Dose for Post Traumatic Stress Disorder

Initial dose: 25 mg orally once a day, increased after one week to 50 mg orally once a day
Maintenance dose: 50 to 200 mg orally once a day

Comments:
-Dose adjustments may be made at intervals of at least one week.
-These conditions generally required several months or longer of sustained pharmacological therapy beyond initial treatment.

Usual Adult Dose for Social Anxiety Disorder

Initial dose: 25 mg orally once a day, increased after one week to 50 mg orally once a day
Maintenance dose: 50 to 200 mg orally once a day

Comments:
-Dose adjustments may be made at intervals of at least one week.
-These conditions generally required several months or longer of sustained pharmacological therapy beyond initial treatment.

Usual Adult Dose for Premenstrual Dysphoric Disorder

Continuous regimen:
Initial dose: 50 mg orally once a day during the menstrual cycle
Maintenance dose: 50 to 150 mg orally once a day during the menstrual cycle

Cyclic regimen:
Initial dose: 50 mg orally once a day starting 14 days prior to the anticipated start of menstruation through to the first full day of menses, and repeated with each new cycle
Maintenance dose: 50 to 100 mg orally once a day

Comments:
-The dose may be increased in increments of 50 mg per menstrual cycle, increased at the onset of each new cycle; dosage adjustments may also include changes between regimens.
-If a 100 mg once daily dose has been established with the cyclic regimen, a titration step of 50 mg per day for three days should be used at the beginning of each dosing period (luteal phase of the menstrual cycle).
-The effectiveness of sertraline for longer than three months has not been systematically evaluated in controlled trials.

Usual Pediatric Dose for Obsessive Compulsive Disorder

6 to 12 years:
Initial dose: 25 mg orally once a day
Maintenance dose: 25 to 200 mg orally once a day

13 to 17 years:
Initial dose: 50 mg orally once a day
Maintenance dose: 50 to 200 mg orally once a day

Comments:
-The dose may be increased at intervals of at least one week.
-The potential risks versus clinical need should be assessed prior to using this drug in children and adolescents.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Liver dysfunction: Use with caution; lower or less frequent dosing may be appropriate

Dose Adjustments

Dose adjustments should be made to maintain patients on the lowest effective dose.

Switching from:
-MAOI to sertraline therapy: At least 14 days should elapse
-Sertraline to MAOI therapy: At least 14 days should elapse

Treatment withdrawal:
-A gradual dose reduction is recommended instead of abrupt cessation where possible.
-If intolerable symptoms occur, it is recommended to consider resuming the previously prescribed dose and to decrease the dose at a more gradual rate.

Precautions

US BOXED WARNING:
-Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.
-Anyone considering the use of sertraline or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.
-Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 years and older.
-Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide.
-Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior.
-Families and caregivers should be advised of the need for close observation and communication with the prescriber.
-Sertraline is not approved for use in pediatric patients (aged 6 to 17 years) except for patients with obsessive compulsive disorder (OCD).

Safety and efficacy have not been established in patients younger than 6 years.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: No adjustment recommended
Peritoneal dialysis: Data not available

Other Comments

Administration advice:
-Doses may be given either in the morning or evening
-Sertraline oral concentrate solution should be diluted immediately before administration

Reconstitution/preparation techniques:
-The required dose of oral concentrate solution should be measured and mixed with half a cup of water, ginger ale, lemon/lime soda, lemonade, or orange juice only.

General:
-The need for ongoing treatment should be regularly reviewed
-Patients should be maintained on the lowest effective dose
-For the treatment of PTSD, OCD and panic disorder, it is not known whether the dose of sertraline needed for maintenance is identical to the dose needed to achieve an initial response

Monitoring:
-Hepatic: Liver function
-Metabolic: Hyponatremia
-Nervous system: Serotonin syndrome
-Psychiatric: Emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Patient advice:
-Tell your healthcare provider about all of the medicines that you take, including prescription and non-prescription medicines.
-This medicine may increase the risk of suicidal thoughts and behavior. Be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report any behavior of concern to your healthcare provider as soon as possible.
-This medicine may cause impaired judgment, thinking, or motor skills; do not drive a care or operate dangerous machinery until you know how this drug affects you.
-Concomitant ingestion of alcohol is not advised.

Zoloft Side Effects