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Zoloft (Sertraline Hydrochloride) - Summary

 
 



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 Zoloft 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. Zoloft is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use)

 

ZOLOFT SUMMARY

ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate

ZOLOFT® (sertraline hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) for oral administration.

ZOLOFT is indicated for the following:

Major Depressive Disorder- ZOLOFT® (sertraline hydrochloride) is indicated for the treatment of major depressive disorder.

Obsessive-Compulsive Disorder- ZOLOFT is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD).

Panic Disorder- ZOLOFT is indicated for the treatment of panic disorder, with or without agoraphobia.

Posttraumatic Stress Disorder (PTSD)- ZOLOFT (sertraline hydrochloride) is indicated for the treatment of posttraumatic stress disorder.

Premenstrual Dysphoric Disorder (PMDD) - ZOLOFT is indicated for the treatment of premenstrual dysphoric disorder (PMDD).

Social Anxiety Disorder - ZOLOFT (sertraline hydrochloride) is indicated for the treatment of social anxiety disorder, also known as social phobia.
See all Zoloft indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Zoloft (Sertraline)

Study of the use of antidepressants for depression in dementia: the HTA-SADD trial--a multicentre, randomised, double-blind, placebo-controlled trial of the clinical effectiveness and cost-effectiveness of sertraline and mirtazapine. [2013]
compared with placebo... CONCLUSIONS: This is a trial with negative findings but important clinical

Factors associated with non-completion in a double-blind randomized controlled trial of olanzapine plus sertraline versus olanzapine plus placebo for psychotic depression. [2012]
High rates of attrition have been reported in randomized controlled trials of patients with severe psychiatric illness, including psychotic depression (MDpsy). The purpose of this study is to examine factors associated with overall attrition and with subtypes of attrition in the Study of the Pharmacotherapy of Psychotic Depression (STOP-PD).

Obstructive sleep apnea/hypopnea syndrome and poor response to sertraline in patients with coronary heart disease. [2012]
CONCLUSIONS: Obstructive sleep apnea/hypopnea syndrome is associated with a

Sertraline delays relapse in recently abstinent cocaine-dependent patients with depressive symptoms. [2012]
mg/day delays relapse in recently abstinent cocaine-dependent individuals... CONCLUSIONS: Sertraline delays time to relapse relative to placebo in

Poor response to sertraline in methamphetamine dependence is associated with sustained craving for methamphetamine. [2011.11.01]
CONCLUSIONS: Some MA-abusing individuals treated with SSRIs have sustained craving with an increased propensity to relapse during treatment despite psychosocial treatment interventions. Published by Elsevier Ireland Ltd.

more studies >>

Clinical Trials Related to Zoloft (Sertraline)

A Comparison of Sertraline-Reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression. [Completed]
This study was designed to determine if the novel combination of the SSRI, sertraline, and the NRI reboxetine will increase antidepressant efficacy without sacrificing the favorable safety profile of SSRIs.

Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration [Recruiting]
This study aimed to explore the pharmacokinetics and pharmacodynamics of low dose sertraline with [11C] sertraline positron emission tomography (PET) study.

A Research Study to Compare the Treatments of a Combination of Elzasonan With Zoloft, to Zoloft Alone, or Placebo in People With Major Depressive Disorder (MDD) [Completed]
The major purpose of the study is to help determine whether giving the combination of Elzasonan with Zoloft to people with depression is a better treatment than taking Zoloft alone. This study will also compare the safety and tolerability of Elzasonan and Zoloft combination to Zoloft alone or placebo.

Pharmacokinetic Properties of Sertraline Before and After Gastric Bypass Surgery [Recruiting]
This study is being conducted to evaluate how the body absorbs and processes the medication sertraline (Zoloft®) before compared to how it is absorbed at two time points after gastric bypass surgery. Participants will be asked to take part in this study at three time points: 1) before their bariatric surgery, 2) at three months following the surgery, and 3) twelve months following surgery. This study will enroll approximately 30 participants.

Study of Sertraline Hydrochloride Tablets 100 mg and Zoloft® Tablets 100 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's sertraline hydrochloride 100 mg tablets to Pfizer's Zoloft® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administered under fasting conditions.

more trials >>

Reports of Suspected Zoloft (Sertraline) Side Effects

Maternal Exposure Timing Unspecified (602)Atrial Septal Defect (338)Foetal Exposure During Pregnancy (267)Patent Ductus Arteriosus (227)Ventricular Septal Defect (223)Drug Ineffective (211)Tricuspid Valve Incompetence (182)Cardiomegaly (165)Depression (157)Heart Disease Congenital (151)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 52 ratings/reviews, Zoloft has an overall score of 7.56. The effectiveness score is 8 and the side effect score is 7.88. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Zoloft review by 45 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   anxiety
Dosage & duration:   50 mg /day taken 1x day for the period of 4 years
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   Completely eliminated anxiety disorder characterized by panic attacks and generalized anxiety after dosage of 50 mg/day was taken. Downsside was that while on 25 mg/day start up dose for the first 7 days anxiety was extremely worsened and almost unbearable.
Side effects:   Initial weight loss
Comments:   Patient taking 50 mg/day for generalized anxiety disorder and panic attacks. Initial start up dose 25 mg/day for 7 days. Anxiety extremely heightened and patient almost disscontinued med because of it. Hung in there and pill started to decrease and finally eliminate anxiety.

 

Zoloft review by 56 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   head injuries
Dosage & duration:   200 mg taken once per day for the period of 12 years
Other conditions:   depression
Other drugs taken:   none
  
Reported Results
Benefits:   Due to a car accident I sustained head injuries in addition to physical body injuries (broken bones, etc.) I had terrible mood swings. Through the assistance of a Psycharist subscribing Zoloft, gradually I became calmer. I didn't cry as often for no apparent reason or get irritated at the drop of a hat. My short term memory returned and I became less self conscious.
Side effects:   Sometimes I experienced a slight ticking in my head as if I had something in my brain clicking all the time. If I do not take the Zoloft when I get up (later in the day) I get headachs. No other side effects.
Comments:   Initial dosage was 50 mg gradually over two year my span dosage increased to 200 mg. I still am taking Zoloft. I am somewhat fraid my symptoms will resurface. I am also concerned about any withdrawals or headachs.

 

Zoloft review by 34 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   1 pill a day taken every day for the period of 45 days
Other conditions:   IBS
Other drugs taken:   none
  
Reported Results
Benefits:   I had no benefits. It didn't seem to make anything better at the time. It seemed the depression was still the same and then I had side effects that affected me daily.
Side effects:   I suffered from daily Headaches and also slight nausea every once in awhile. I also felt very dried out and thirsty. It also affected me by lowering my libido.
Comments:   I was supposed to take a pill every morning with water. I felt better once I stopped taking the pills and actually just started working on myself and my goals and then also wehn I started doing volunteer work to help children.

See all Zoloft reviews / ratings >>

Page last updated: 2014-11-30

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