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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)

Is sertraline treatment or depression remission in depressed Alzheimer patients associated with improved caregiver well being? Depression in Alzheimer's Disease Study 2. [2014]
is associated with improved caregiver well being... CONCLUSION: Patient treatment with sertraline was not associated with

Specificity profile of venlafaxine and sertraline in major depression: metaregression of double-blind, randomized clinical trials. [2014]
Despite the well-known efficacy of selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) in the treatment of major depressive disorder, there is a lack of indications for each drug in different groups of patients...

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

more studies >>

Clinical Trials Related to Zoloft (Sertraline)

Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects [Completed]
The purpose of this study is to assess the bioequivalence of Zoloft ODT 50 mg with and without water to Japanese commercial oral tablet of JZoloft 50 mg under fasting condition with water in Healthy Japanese Subjects

Sertraline Compared With Hypericum Perforatum (St.John's Wort) in Treating Depression [Completed]
RATIONALE: Antidepressants such as sertraline and the herb hypericum perforatum (St. John's wort) may be effective in treating mild to moderate depression. It is not yet known which treatment is more effective in improving depression in patients who have cancer. PURPOSE: This randomized phase III trial is studying how well sertraline works compared to St. John's wort in treating mild to moderate depression in patients with solid tumors.

An 8-week, Open-label Study to Evaluate the Effect of Sertraline on Polysomnogram in Depressive Patients With Insomnia [Completed]
Major depressive disorder is associated with several sleep Polysomnograph (PSG) findings: (1) impaired sleep continuity; (2) non-REM (NREM) changes; and (3) enhanced rapid eye movement (REM) sleep. The first two patterns are common in other psychiatric disorders, while the REM pattern is very characteristic in depression, so the phase-advance theory was accepted by most of psychiatrists. Many researchers have focused on the biological rhythm to investigate the etiological and pathophysiology of depression, and they think depression can be cured if its sleep abnormality is ameliorated. It is well known that most of antidepressants treat depression through 5-hydroxytryptamine (5-HT) neurons. 5-HT also affects the regulation of the sleep-wake cycle and the sleep microarchitecture. Many all-night PSG studies have shown tricyclic antidepressants can ameliorate the sleep architecture abnormality in depression by producing rapid suppression of REM sleep. Compared to TCAs, SSRIs are generally less sedating because of its high selectivity for serotonin receptors. SSRIs can suppress REM sleep and delay REM latency too, but they increase awakenings and reduce SWS at the same time. One PSG study shown sertraline minimally increases sleep efficiency and reduces nocturnal wakefulness time, which may benefit depressive patients. However, this study compared the sleep architecture before and after 12 weeks of pharmacotherapy, so the tolerance to the disturbance of sleep architecture in antidepressants appears to develop over several weeks of treatment. Sertraline has a greater potency against 5-HT reuptake as well as better selectivity for 5-HT reuptake relative to NE reuptake than any other SSRIs, and the relative selectivity of sertraline for inhabiting 5-HT reuptake relative to DA reuptake is somewhat less than of any other SSRIs. So it has chance to exhibit better effect on sleep architecture in depressive patients. Finally, it is difficult to be determined that the unique phenomenon of sertraline is its genuine characteristics or the tolerance after 12-week treatment, so it is crucial to assess the effect of sertraline on sleep architecture in acute treatment. We hypothesized that sertraline could suppress the REM sleep, and have little damage to the sleep architecture of depressive patient.

Special Investigation Of Long Term Use Of Sertraline. [Completed]
Special investigation of long term use of sertraline, 52 Week Observation, Long-Term Safety. The objective of this "Special investigation" is to collect information about 1) adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug regarding long time use.

Pharmacokinetic Properties of Sertraline Before and After Gastric Bypass Surgery [Active, not 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.

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: 2015-08-10

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