Side effects of Zoloft
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What are the most common side effects of Zoloft?
Some people taking Zoloft might have some side effects. The most common Zoloft side effects are dry mouth, insomnia, sexual side effects, diarrhea, nausea, and sleepiness. Not everyone gets side effects.
If I get side effects, will they go away?
Any side effects will most likely lessen over time. Be sure to tell your doctor about any side effects you might be having.
Will I gain weight on Zoloft?
Studies show that Zoloft is not associated with weight gain, so you shouldn’t gain weight because of Zoloft.
Is Zoloft addictive?
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No. In medical studies, it has been shown that Zoloft is not addictive or habit-forming.
Will my personality change while I’m taking Zoloft?
No, taking Zoloft won’t change who you are as a person. Zoloft treats your depression and certain types of anxiety disorders.
Can I drink alcohol while on Zoloft?
Taking Zoloft with alcohol isn’t recommended.
Can Zoloft be taken with other medicines?
Be sure to tell your doctor what medicines you’re taking. If you’re taking a medicine called a monoamine oxidase inhibitor (MAOI) used to treat depression and other conditions or pimozide, you shouldn’t take Zoloft. Concomitant use of Zoloft with NSAIDs or aspirin may be associated with increased bleeding.
Are all antidepressants the same?
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No. Each antidepressant medicine has its own chemical structure. And at the molecular level, small differences in the chemical structure can make a big difference in how they affect you. What’s true of one drug is not always true of the other.
What is the FDA warning all about?
Depression is a serious medical condition, which can lead to suicidal thoughts and behavior. Children, adolescents, and young adults, taking antidepressants, may increase the risk for suicidal thoughts and behavior within the first few months of treatment. This risk must be balanced with the medical need. Those starting medication or changing doses should be watched closely for suicidal thoughts, worsening of depression, or unusual changes in mood or behavior. A patient Medication Guide about “Antidepressant Medicines, Depression and Other Serious Mental Illness, and Suicidal Thoughts or Actions” is available.
Does the warning apply to all antidepressants?
Yes. The FDA warning applies to all antidepressants including: Effexor® (venlafaxine), Cymbalta® (duloxetine), Lexapro® (escitalopram), Celexa® (citalopram), Paxil® (paroxetine), Prozac® (fluoxetine), Wellbutrin® (bupropion), Zyban® (bupropion), Zoloft® (sertraline) and medications called TCAs (tricyclic antidepressants), MAOIs (monoamine oxidase inhibitors), and atypical antidepressants, as well as Pfizer’s Sinequan® (doxepin) and Nardil® (phenelzine).
Panic Disorder
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Sertraline hydrochloride is indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.
The efficacy of sertraline hydrochloride was established in three 10-12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see CLINICAL TRIALS under CLINICAL PHARMACOLOGY).
Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.
The efficacy of sertraline hydrochloride in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see CLINICAL TRIALS under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
Summary
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ZOLOFT Pfizer
Sertraline HCI
Use:
SSRI. Depression: Patients > 18 years of age: Initially, 50 mg once daily; increase dosage gradually, if needed, at 1-week intervals. Maximum: 200 mg/day. Maintenance: lowest effective dose.
Panic disorder: 25 mg once daily and increase, if necessary, by 50 mg increments at intervals of no less than 1 week, to a maximum of 200 mg/day.
Obsessive-compulsive disorder (OCD): Initially, 50 mg/day. Thereafter, increase the dosage, if necessary, by 50 mg increments, over several weeks or months, to a maximum of 200 mg/day.
Zoloft’s effectiveness for more than 12 weeks of therapy in panic disorder and OCD not yet established.
Contraindications:
Not to be use with an MAOI or within 14 days of starting or discontinuing MAOI therapy. Concomitant use with pimozide.
Precautions:
Pregnancy, lactation, patients< 18 years of age. Seizure disorders, a history of drug abuse, renal or hepatic impairment. Activation of mania/hypomania, suicidal tendency, concomitant illnesses that could affect metabolism or hemodynamic responses. Rare reports of altered platelet function; hyponatremia, possibly due to the syndrome of inappropriate antidiuretic hormone secretion.
Side effects:
Nausea, diarrhea/loose stools, dyspepsia, male sexual dysfunction (primarily ejaculatory delay), insomnia, somnolence, tremor, increased sweating, dry mouth, dizziness.
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Interactions:
See Contraindications. Use cautiously with CNS-active drugs; serotonergic drugs, such as fenfluramine, should not be used with sertraline. Hypoglycemic agents, drugs highly bound to plasma proteins, cimetidine (may decrease clearance of sertraline). Warfarin (monitor PT). St. John’s Wort (increase in undesirable effects).
Patient tips:
Full therapeutic effect may be delayed until 4 or more weeks of treatment. Take capsules with food once daily, preferably with evening meal or breakfast. May cause dizziness (NB driving). Restrict alcohol intake.
Supplied:
25 mg, 50 mg, 100mg capsules.
Indications
Sertraline has been approved for the following indications: depression, obsessive-compulsive disorder (OCD), posttraumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD), panic disorder (PD) and social phobia/social anxiety disorder.
Depression
The original clinical trials demonstrated only moderate efficacy of sertraline for depression (see History). Nevertheless, later research firmly established sertraline as one of the drugs of choice for the treatment of depression in outpatients. In addition, sertraline is effective for dysthymia and comparable to imipramine in that respect. In the treatment of depression accompanied by OCD, sertraline performed significantly better than desipramine (Norpramine) on the measures of both OCD and depression.
Comparison with tricyclic antidepressants
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Sertraline has a similar effect on the core depressive symptoms as the tricyclic antidepressants (TCAs); however, it is better tolerated and results in a better quality of life.
For example, similar improvement of depression scores was in comparative studies of sertraline versus clomipramine (Anafranil) and amitriptyline (Elavil). At the same time, sertraline resulted in a much lower rate of side effects than amitriptyline (49% vs 72% vs 32% for placebo), particularly dry mouth, somnolence, constipation and increased appetite. However, there were more cases of nausea and sexual dysfunction in the sertraline group. Furthermore, sertraline patients showed a greater improvement of the subjective quality of life on such measures as work satisfaction, subjective feeling, perceptions of health and cognitive function.
A large and thorough double-blind study compared sertraline, prescribed for chronic (longer than 2 years) depression or depression with dysthymia, to the “gold standard” of depression treatment TCA imipramine (Tofranil). Sertraline was equivalent to imipramine for both of these indications during the first 12 weeks of the study and the 16 weeks continuation phase. Only 11% of patients on sertraline suffered severe side effects vs. 24% on imipramine. Constipation, dizziness, tremor, dry mouth, micturition disorder and sweating adverse effects were observed more often with imipramine, and diarrhea and insomnia with sertraline. Sertraline patients also reported significantly better social and physical functioning. Interestingly, the patients who achieved a remission during the trial (30% of the sample) did not differ from the healthy population on the measures of marital, parental, physical and work functioning and were close to normal on social adjustment and other measures of interpersonal functioning.
Comparison with other antidepressants
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Comparative clinical trials demonstrated that sertraline’s efficacy in depression is similar to moclobemide (Aurorix), nefazodone (Serzone),, escitalopram (Lexapro), bupropion (Wellbutrin)., citalopram (Celexa), fluvoxamine (Luvox), paroxetine (Paxil) and mirtazapine (Remeron). Remarkably, the patients on sertraline had much higher rate of sexual dysfunction (61% vs 10% for men and 41% vs 7% for women), nausea, diarrhea, somnolence and sweating as well as rate of discontinuation due to the side effects (13% vs 3%) than the patients on bupropion. Meta-analysis by the independent Cochrane Collaboration indicated that sertraline is more effective for the treatment of depression than fluoxetine (Prozac) (probability of response 1.4 times higher) and, possibly, is better tolerated. Three comparative studies of sertraline and venlafaxine (Effexor) have been conducted. In the first study supported by the venlafaxine manufacturer Wyeth and in the second — by the sertraline manufacturer Pfizer, sertraline performed marginally worse on some psychiatric scales and similarly to venlafaxine on others. However, the former study was criticized for the methodology shortcomings. A third study, funded by Pfizer, found no differences between sertraline and venlafaxine.
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