Sertraline (SER tra leen)

Overview

Sertraline is available as sertraline hydrochloride (Zoloft), an antidepressant, in a tablet form and an oral solution.  Sertraline (Zoloft), like the earlier antidepressant fluoxetine (Prozac), works by enhancing the action of a brain chemical called serotonin. It belongs to the class of antidepressant drugs called serotonin reuptake inhibitors (SSRIs).

This medication is prescribed to treat major depression, obsessive-compulsive disorder, panic disorders, social anxiety disorder, post traumatic stress disorder, and premenstrual dysphoric disorder.

Although the FDA has not specifically approved its use for other purposes, doctors sometimes prescribe sertraline (Zoloft) to treat generalized anxiety, impulse control, and eating disorders.

People’s Pharmacy Perspective

Since the introduction of fluoxetine (Prozac) in 1987, the serotonin reuptake inhibitor (SSRI) class of antidepressants (citalopram-Celexa, escitalopram-Lexapro, fluoxetine- Prozac, fluvoxamine-Luvox, olanzapine plus fluoxetine-Symbyax, paroxetine-Paxil, sertraline-Zoloft) has been wildly popular with physicians, patients, and insurance companies.

Doctors believe SSRIs generally produce fewer side effects than traditional tricyclic antidepressants, though it is not clear whether there are fewer adverse events or just different ones. These drugs are perceived as less costly and time consuming than talk therapy, though a monthly prescription for a brand name SSRI-type antidepressant can cost more than $100.

The FDA now recognizes suicidal thoughts as a potential complication of virtually all antidepressant therapy for children, adolescents, and young adults (18-24 year olds) during the first few months of treatment and whenever there are dosage changes.  Why one would assume that suicidal thoughts would instantly stop at age 25 is a mystery to us. We think that anyone who is put on this type of antidepressant should be aware of the potential for violent, suicidal thoughts. Family members and friends must also be vigilant for any unusual changes and encourage immediate consultation with the prescriber.

When it comes to effectiveness, antidepressants can be helpful for some people, but trial and error may still be the only way to determine whether a given antidepressant is helpful.  There is no clear evidence that any one drug (including duloxetine-Cymbalta or venlafaxine-Effexor) is better than others.(1) There is also no clear data to demonstrate that these antidepressants are substantially better than placebo more than half the time.(2) More significantly, there is little evidence to show that they affect long-term outcomes or suicide rates.(3)

A recent review demonstrated that the medical literature is incomplete with regard to clinical trials. Favorable trials are published more frequently than trials showing no benefit beyond placebo.  As a result, doctors reading the published studies are likely to get a far more favorable impression of an antidepressant than may be warranted.(4)

For many, a long acting medication like fluoxetine (Prozac) is preferred for avoiding withdrawal symptoms (dizziness, nausea, insomnia, headache, sweating) experienced when stopping or switching from other antidepressants.  We have heard from many people that getting off drugs like venlafaxine-Effexor, paroxetine-Paxil or sertraline-Zoloft can be difficult.

The bottom line is that there are no “best choices” when it comes to antidepressants.  Patients must be open to trial and error when starting, be cautious to taper off antidepressants when ending or switching therapies, and constantly be under knowledgeable medical guidance throughout therapy.

Be certain to consult a physician about your health, especially with regard to any signs or symptoms that may require diagnosis or medical attention.  Information provided is not a substitute for the medical advice or care of a physician or other health care professional.

Special Precautions

There is increased risk of suicidal thoughts in children, adolescents, and young adults with major depressive or other psychiatric disorders especially during the first months of treatment with antidepressants.  Antidepressants are not approved for pediatric patients except for treating obsessive compulsive disorder.

Pregnancy/Breastfeeding:  Consult your prescribing physician and/or obstetrician if you are pregnant or planning a pregnancy, or will be breastfeeding while taking this medication.

Not recommended:  People who have had an allergic reaction to SSRIs, sertraline (Zoloft), or its components or who are taking the MAOI class of antidepressants (isocarboxazid-Marplan, phenelzine-Nardil, tranylcypromine-Parnate, selegiline-EmSam) or drugs with MAOI activity such as pimozide (Orap) or linezolid (Zyvox).  Potentially fatal interactions could occur between MAOI and SSRI antidepressants so MAOIs must be stopped for 14 days prior to beginning SSRI therapy and vice versa.

Those who are on disulfiram (Antabuse) should avoid liquid sertraline (Zoloft) due to its alcohol content.

Another potentially fatal drug interaction could result from taking another SSRI with sertraline. This may lead to serotonin syndrome. Patients taking sertraline should avoid other SSRIs such as escitalopram (Lexapro) or a SNRI antidepressant (duloxetine-Cymbalta, venlafaxine-Effexor, Effexor XR), St. John’s wort, tramadol (Ultram), and migraine medications (sumatriptan-Imitrex, Zolmitriptan-Zomig).  The doctor must be notified immediately if there are sudden changes in cognition (confusion, agitation, headache) accompanied by shivering, sweating, fever, increased heart rate, muscle twitching or tremor.

Carefully monitor:  For people who have bipolar disorder and have had an episode of mania, there is a risk that manic symptoms could be triggered by sertraline (Zoloft).  Anyone with a history of seizures or suicide attempts must also be extremely vigilant. Family members and other caregivers should help monitor people on sertraline for suicidal thoughts, self-destructive behaviors, panic attacks, impulsivity, aggressiveness, or other unusual changes in behavior or symptoms of worsening depression or anxiety especially in the early months of treatment and when the dose is adjusted. The doctor must be notified immediately in such cases.

People with liver problems may need to start on a reduced dose, as they may eliminate Zoloft less efficiently than otherwise healthy people.  Be certain to inform your doctor of any other conditions you may have as it may affect your dose, whether you should even take this medication, or require you to take special tests during treatment.

Taking the Medication

Sertraline (Zoloft) tablets should be taken with a full glass of water roughly at the same time each day (to help you to remember to take it), with or without food.

Stopping the Medication

It may take up to 4 weeks or longer before effects are felt.  Do not stop or change doses suddenly without first talking with your doctor.  If sertraline (Zoloft) is abruptly discontinued, withdrawal symptoms such as irritability, agitation, dizziness, electric shock sensations, anxiety, headaches, and increased manic episodes may occur.  Discontinuation is usually handled with a gradual reduction in dose.

Common Side Effects

• Dizziness, drowsiness, nausea
• Dry mouth, appetite changes
• Sexual difficulties, changes in sex drive

Serious Side Effects

Call for emergency help if you have these signs of a potential allergic reaction: difficulty breathing, swelling of the face, throat, lips, or tongue, skin rash or hives.

Call your doctor promptly if you have any of these serious side effects:

• Seizure (convulsions)
• Serotonin Syndrome (rare, but potentially fatal condition in which serotonin levels are elevated to toxic levels by the action of a single or a combination of medications)
• Uncontrolled muscle twitching, tremors, stiffness, or shivering
• Fast heart rate, unusual sweating, fever
• Agitation, confusion

There may be other side effects not listed here. Talk to your doctor if your condition worsens and about any side effect that seems unusual or is especially bothersome.

Drug Interactions

I. DO NOT TAKE WITH sertraline (Zoloft):

The following drugs have additive effects to SSRIs, so may increase the risk for serotonin syndrome, a (rare, but potentially fatal condition in which serotonin levels are elevated to toxic levels by the action of a single or a combination of medications):

• Migraine medications: sumatriptan (Imitrex), zolmitriptan (Zomig), and others
• Tramadol (Ultram), Lithium
• All other antidepressant drug classes:  SNRIs (duloxetine-Cymbalta, venlafaxine-Effexor, Effexor XR), SSRIs (escitalopram-Lexapro, fluoxetine-Prozac, etc.), tricyclics (nortriptyline-Pamelor, protriptyline-Vivactil)
• MAOI antidepressants; drugs with MAOI like activity: Phenelzine (Nardil), isocarboxazid (Marplan),  tranylcypromine (Parnate),  selegiline (EmSam) and linezolid (Zyvox).  These need to be stopped at least two weeks prior to starting sertraline (Zoloft). If sertraline is taken first, two weeks should elapse before starting on one of these other medicines as potentially fatal side effects could occur.
• Pimozide (Orap):  increases risk of fatal cardiac complications.
• Sibutramine (Meridia):  not recommended by manufacturer.  Use only under close medical supervision, particularly for signs of serotonin syndrome, since effects are additive to sertraline (Zoloft)
• Muscle relaxers and cold, pain, anti-seizure, anti-anxiety and antidepressant medicines that could make you sleepy should also be avoided.
• Alcohol: increases drowsiness and dizziness

II. TAKE with CLOSE MEDICAL MONITORING

Propafenone (Rythmol):  Certain SSRIs, including sertraline (Zoloft), may increase the level of this drug, so cardiac function should be carefully monitored.  Or, use an alternate antidepressant, such as citalopram (Celexa).

III. DOSE ADJUSTMENT may be required

• Clozapine, risperidone, cyclosporine, seizure medications (phenytoin-Dilantin, ethotoin-Peganon), propafenone (Rythmol):  The dose of these drugs may need to be adjusted if they are taken with sertraline (Zoloft).
• Cyproheptadine:  This antihistamine/allergy medication may block the activity of SSRI antidepressants, so its discontinuation may be advised if antidepressant effects seem blunted or the sertraline (Zoloft) dose may need to be adjusted.
• Carbamazepine (Tegretol): Decreases effectiveness of sertraline (Zoloft), so sertraline dose may need to be adjusted.
• Aspirin, ibuprofen, naproxen, diclofenac (Voltaren), etodolac (Lodine) warfarin (Coumadin) or other drugs that affect blood clotting:  Drugs that interfere with serotonin reuptake and these agents have been associated with an increased risk of abnormal bleeding, so the dose of these agents may need to be adjusted.

Other Interactions

• St. John’s wort (5): Avoid taking the herb St. John’s wort with sertraline (Zoloft), since the effects are additive and could lead to serotonin syndrome. Switching between antidepressants and herbal treatment calls for medical guidance (physicians can find a suggested protocol for gradual substitution of St. John’s wort in Hyla Cass’s book, St. John’s Wort: Nature’s Blues Buster).
• Grapefruit Juice (6):  Avoid taking sertraline (Zoloft) with grapefruit juice as this may result in elevated drug levels in the bloodstream

There may be other herbal and dietary supplement or food interactions not listed here.  We are concerned for instance, about the potential for bleeding with herbs that may affect coagulation (Ginko biloba, etc).  Check with your doctor and pharmacist before taking any other supplements or over the counter medications to make sure you are aware of the risks the combination may carry.

References

1. Khan, A. and Schwartz, K.  “Study Designs and Outcomes in Antidepressant Clinical Trials.”  Essent. Psychopharmacol.  2005;6:221-226
2. Moncrieff, J. and Kirsch, I.  “Efficacy of Antidepressants in Adults.” BMJ 2005;331:155-159
3. Rubinow, D.R. “Treatment Strategies After SSRI Failure–Good News and Bad News.” N. Engl. J. Med. 2006;354:1305-1307
4. Turner, E. H., et al.  “Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy.” N. Engl. J. Med. 2008; 358(3):252-260
5. Lantz MS, et al. “St. John’s wort and antidepressant drug interactions in the elderly.” J Geriatr Psychiatry Neurol. 1999;12:7-10. PubMed
6. Lee AJ, et al. “The effects of grapefruit juice on sertraline metabolism: an in vitro and in vivo study.” Clin Ther. 1999;21:1890-1899

Be certain to consult a physician about your health, especially with regard to any signs or symptoms that may require diagnosis or medical attention.  Information provided is not a substitute for the medical advice or care of a physician or other health care professional.