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

• You may have an increased risk of suicidal thoughts or behavior at the start of treatment with an antidepressant medication, especially if you are under 18 years old. Talk with your doctor about this risk. While you are taking Zoloft you will need to be monitored for worsening symptoms of depression and/ or suicidal thoughts during the first weeks of treatment, or whenever your dose is changed. In addition to you watching for changes in your own symptoms, your family or other caregivers should be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.
• Contact your doctor promptly if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and/ or physical hyperactivity), thoughts of suicide or hurting yourself.
• Do not take Zoloft together with pimozide (Orap), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). You must wait at least 14 days after stopping an MAOI before you can take Zoloft.

What is Zoloft?

• Zoloft is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Zoloft affects chemicals in the brain that may become unbalanced and cause depression, panic, anxiety, or obsessive-compulsive symptoms.
• Zoloft is used to treat depression, obsessive-compulsive disorder, panic disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).
• Zoloft may also be used for purposes other than those listed in this medication guide.

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

• You may have an increased risk of suicidal thoughts or behavior at the start of treatment with an antidepressant medication, especially if you are under 18 years old. Talk with your doctor about this risk. While you are taking Zoloft you will need to be monitored for worsening symptoms of depression and/ or suicidal thoughts during the first weeks of treatment, or whenever your dose is changed. In addition to you watching for changes in your own symptoms, your family or other caregivers should be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.
• Do not use Zoloft if you are using pimozide (Orap), or an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam). Serious and sometimes fatal reactions can occur when these medicines are taken with Zoloft. You must wait at least 14 days after stopping an MAO inhibitor before you can take Zoloft.
• Before taking Zoloft, tell your doctor if you have:
  • liver or kidney disease;
  • seizures or epilepsy;
  • bipolar disorder (manic depression); or
  • a history of drug abuse or suicidal thoughts.
• If you have any of these conditions, you may not be able to use Zoloft, or you may need a dosage adjustment or special tests during treatment.
• FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
• It is not known whether Zoloft passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Zoloft?

• Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from the medication.
• Take each tablet with water.
• Try to take the medicine at the same time each day.
• The oral liquid form of this medicine must be diluted before you take it. To be sure you get the correct dose, measure the liquid with medicine dropper provided, not with a regular table spoon. 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.
• Try to take Zoloft at the same time each day.
• Zoloft may be taken with or without food.
• It may take 4 weeks or more for you to start feeling better. Do not stop using Zoloft without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly.
• Store Zoloft at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

• Seek emergency medical attention if you think you have taken too much of this medication. Symptoms of a Zoloft overdose may include dizziness, drowsiness, nausea, vomiting, rapid heartbeat, agitation, tremor, confusion, seizures, and coma.

What should I avoid while taking Zoloft?

• Do not take Zoloft together with pimozide (Orap), isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).
• Avoid drinking alcohol, which can increase some of the side effects of Zoloft.
• Do not take the liquid form of Zoloft if you are taking disulfiram (Antabuse). Liquid Zoloft may contain alcohol and you could have a severe reaction to the disulfiram.
• Avoid using other medicines that make you sleepy (such as cold medicine, other pain medication, muscle relaxants). They can add to sleepiness caused by Zoloft.
• Zoloft can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What are the possible side effects of Zoloft?

• 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.
• Contact your doctor promptly if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and/ or physical hyperactivity), thoughts of suicide or hurting yourself.
• Call your doctor at once if you have any of these serious side effects:
  • seizure (convulsions);
  • tremors, shivering, muscle stiffness or twitching;
  • problems with balance or coordination; or
  • agitation, confusion, sweating, fast heartbeat.
• Other less serious side effects are more likely to occur, such as:
  • feeling nervous, restless, or unable to sit still;
  • drowsiness, dizziness, weakness;
  • sleep problems (insomnia);
  • nausea, diarrhea, dry mouth, or changes in appetite or weight; or
  • decreased sex drive, impotence, or difficulty having an orgasm.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Zoloft?

• Talk to your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with Zoloft may cause you to bruise or bleed easily.
• Before taking Zoloft, tell your doctor if you are using any of the following medicines:
  • tramadol (Ultram, Ultram ER, Ultracet);
  • digitoxin (Crystodigin);
  • phenytoin (Dilantin);
  • valproate (Depacon, Depakene);
  • lithium (Lithobid, Eskalith);
  • a blood thinner such as warfarin (Coumadin);
  • any other antidepressants such as amitriptyline (Elavil), citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), or paroxetine (Paxil);
  • almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig); or
  • heart rhythm medication such as flecainide (Tambocor), propafenone (Rhythmol), and others.
• If you are using any of these drugs, you may not be able to use Zoloft, or you may need dosage adjustments or special tests during treatment.
• There may be other drugs not listed that can affect Zoloft. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.