Zoloft (generic: sertraline) is a prescription medication used to treat major depressive disorder, obsessive compulsive disorder, panic disorder, post traumatic stress disorder, social anxiety disorder and premenstrual dysphoric disorder.
Zoloft belongs to a group of drugs called selective serotonin reuptake inhibitors (SSRI). It is believed to work by regulating the chemical serotonin in the brain.
This medication comes in tablet and liquid form, and is usually taken 1-2 times daily.
Common side effects of Zoloft include nausea, headache, and insomnia.
This medication may cause drowsiness. Do not drive or operate heavy machinery until you know how sertraline affects you.
Zoloft is a prescription medication used to treat major depressive disorder, obsessive compulsive disorder, panic disorder, post traumatic stress disorder, social anxiety disorder and premenstrual dysphoric disorder.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Sertraline may cause serious side effects, including:
- See "Drug Precautions"
- Feeling anxious or trouble sleeping
Common possible side effects in people who take Sertraline include
- nausea, loss of appetite, diarrhea or indigestion
- change in sleep habits including increased sleepiness or insomnia
- increased sweating
- sexual problems including decreased libido and ejaculation failure
- tremor or shaking
- feeling tired or fatigued
Other side effects in children and adolescents include:
- abnormal increase in muscle movement or agitation
- nose bleed
- urinating more often
- urinary incontinence
- aggressive reaction
- heavy menstrual periods
- possible slowed growth rate and weight change. Your child's height and weight should be monitored during treatment with Sertraline.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Sertraline. For more information, ask your healthcare provider or pharmacist.
CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.
Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:
- anticoagulants ('blood thinners') such as warfarin (Coumadin);
- antidepressants ('mood elevators') such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil);
- aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn);
- cimetidine (Tagamet);
- diazepam (Valium);
- digoxin (Lanoxin);
- linezolid ;
- lithium (Eskalith, Lithobid);
- medications for anxiety, mental illness, Parkinson's disease, and seizures;
- medications for irregular heartbeat such as flecainide (Tambocor) and propafenone (Rythmol);
- methylene blue;
- oral medications for diabetes such as tolbutamide (Orinase);
- medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig);
- sibutramine (Meridia);
- sleeping pills;
This is not a complete list of Sertraline drug interactions. Ask your healthcare provider or pharmacist for more information.
Sertraline and other antidepressant medicines may cause serious side effects, including:
1. Suicidal thoughts or actions:
- Sertraline and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
- Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
- Watch for these changes and call your healthcare provider right away if you notice:
- New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
- Pay particular attention to such changes when Sertraline is started or when the dose is changed.
Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:
- attempts to commit suicide
- acting on dangerous impulses
- acting aggressive or violent
- thoughts about suicide or dying
- new or worse depression
- new or worse anxiety or panic attacks
- feeling agitated, restless, angry or irritable
- trouble sleeping
- an increase in activity or talking more than what is normal for you
- other unusual changes in behavior or mood
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Sertraline may be associated with these serious side effects:
2. Serotonin Syndrome or Neuroleptic Malignant Syndrome-like reactions. This condition can be life-threatening and may include:
- agitation, hallucinations, coma or other changes in mental status
- coordination problems or muscle twitching (overactive reflexes)
- racing heartbeat, high or low blood pressure
- sweating or fever
- nausea, vomiting, or diarrhea
- muscle rigidity
3. Severe allergic reactions:
- trouble breathing
- swelling of the face, tongue, eyes or mouth
- rash, itchy welts (hives) or blisters, alone or with fever or joint pain
4. Abnormal bleeding: Sertraline and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin, Jantoven), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.
5. Seizures or convulsions
6. Manic episodes:
- greatly increased energy
- severe trouble sleeping
- racing thoughts
- reckless behavior
- unusually grand ideas
- excessive happiness or irritability
- talking more or faster than usual
7. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.
8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
- weakness or feeling unsteady
- confusion, problems concentrating or thinking or memory problems
Do not stop Sertraline without first talking to your healthcare provider. Stopping Sertraline too quickly may cause serious symptoms including:
- anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
- headache, sweating, nausea, dizziness
- electric shock-like sensations, shaking, confusion
Do not take Sertraline if you:
- are allergic to sertraline or any of the ingredients in Sertraline.
- take the antipsychotic medicine pimozide (Orap) because this can cause serious heart problems.
- take Antabuse (disulfiram) (if you are taking the liquid form of Sertraline) due to the alcohol content.
- take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
- Do not take an MAOI within 2 weeks of stopping Sertraline.
- Do not start Sertraline if you stopped taking an MAOI in the last 2 weeks.
People who take Sertraline close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
- high fever
- uncontrolled muscle spasms
- stiff muscles
- rapid changes in heart rate or blood pressure
- loss of consciousness (pass out)
If you take Sertraline, you should not take any other medicines that contain sertraline (sertraline HCl, sertraline hydrochloride, etc.).
Sertraline can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how Sertraline affects you. Do not drink alcohol while using Sertraline.
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Sertraline there are no specific foods that you must exclude from your diet when receiving Sertraline.
Before starting Sertraline, tell your healthcare provider if you:
- Are taking certain drugs such as:
- Medicines used to treat migraine headaches such as triptans;
- Medicines used to treat mood, anxiety, psychotic or thought disorders, such as:
- tricyclic antidepressants
- antipsychotic drugs
- Medicines used to treat seizures such as phenytoin;
- Medicines used to treat pain such as tramadol;
- Medicines used to thin your blood such as warfarin;
- Medicines used to control your heartbeat such as :
- Medicines used to treat type II diabetes such as tolbutamide;
- Cimetidine used to treat heartburn;
- Over-the-counter medicines or supplements such as:
- Aspirin or other NSAIDs
- St. John's Wort
- have liver problems;
- have kidney problems;
- have heart problems;
- have or had seizures or convulsions;
- have bipolar disorder or mania;
- have low sodium levels in your blood;
- have a history of a stroke;
- have high blood pressure;
- have or had bleeding problems;
- are pregnant or plan to become pregnant. It is not known if Sertraline will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy.
- are breastfeeding or plan to breastfeed. Some Sertraline may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Sertraline.
Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Sertraline and some medicines may interact with each other, may not work as well, or may cause serious side effects.
Your healthcare provider or pharmacist can tell you if it is safe to take Sertraline with your other medicines. Do not start or stop any medicine while taking Sertraline without talking to your healthcare provider first.
Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Sertraline will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy.
Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Some Sertraline may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Sertraline.
- Take Sertraline exactly as prescribed. Your healthcare provider may need to change the dose of Sertraline until it is the right dose for you.
- Sertraline Tablets may be taken with or without food.
- Sertraline Oral Concentrate must be diluted before use:
- Follow the instructions carefully
- When diluting Sertraline Oral Concentrate, use ONLY water, ginger ale, lemon/lime soda, lemonade, or orange juice.
- If you are sensitive to latex, be careful when using the dropper to dispense the Oral Concentrate.
- If you miss a dose of Sertraline, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Sertraline at the same time.
Take Sertraline exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.
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.
Premenstrual Dysphoric Disorder
Sertraline treatment should be started with a dose of 50 mg/day, either in the morning or evening.
Dosage for Pediatric Population (Children and Adolescents)
Sertraline treatment should be started 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).
Sertraline should be administered once daily, either in the morning or evening.
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). 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. 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. 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. 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.
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.
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. 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 Sertraline
Symptoms associated with discontinuation of Sertraline and other SSRIs and SNRIs, have been reported. 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.
If you take too much Sertraline, call your healthcare provider or poison control center right away, or get emergency treatment.
Sertraline tablets are available in the following strengths: 25 mg, 50 mg, and 100 mg.
Sertraline Oral Concentrate is a clear, colorless solution containing 20 mg sertraline per mL and 12% alcohol.
Active ingredient: sertraline hydrochloride
- Store Sertraline at room temperature, between 59°F and 86°F (15°C to 30°C).
- Keep Sertraline bottle closed tightly.
Keep Sertraline and all medicines out of the reach of children.
Suicidality and Antidepressant Drugs
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 hydrochloride 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 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 hydrochloride is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD).