Sertraline
Clinical data | |
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Pronunciation | /ˈsɜːrtrəˌliːn/ |
Trade names | Zoloft, Lustral, Setrona, others[1] |
AHFS/Drugs.com | Monograph |
MedlinePlus | a697048 |
License data |
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Pregnancy category |
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Addiction liability | None[3] |
Routes of administration | By mouth |
Drug class | Selective serotonin reuptake inhibitor (SSRI) |
ATC code | |
Legal status | |
Legal status | |
conjugates)[5] | |
Elimination half-life | • Sertraline: 26 hours (32 hours in females, 22 hours in males; range 13–45 hours)[5][6][7][8] • Desmethylsertraline: 62–104 hours[5] |
Excretion | Urine (40–45%)[5] Feces (40–45%)[5] |
Identifiers | |
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JSmol) | |
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Sertraline, sold under the brand name Zoloft among others, is an
Sertraline shares the common side effects and
Sertraline was invented and developed by scientists at
Medical uses
Sertraline has been approved for major depressive disorder (MDD), obsessive–compulsive disorder (OCD), post-traumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD), panic disorder, and social anxiety disorder (SAD). Sertraline is approved for use in children with OCD.[20]
Depression
In meta-analyses, sertraline displays similar efficacy to other SSRI antidepressants, with an odds ratio for response in clinical depression of between 1.44 and 1.67.[21][22] However, as with other antidepressants, the nature and clinical significance of this effect remain disputed.[23][24] A major study of sertraline in a broad primary care population found improvements in general mental health, quality of life, and anxiety.[25] However, it failed to find significant effects on depression in either the mildly or severely depressed, and the clinical relevance and accuracy of the positive effects found have been questioned.[26][27]
In several
Limited pediatric data also demonstrates reduction in depressive symptoms in the pediatric population though remains a second line therapy after fluoxetine.[29][30]
Comparison with other antidepressants
In general, sertraline efficacy is similar to that of other antidepressants.[31] For example, a meta-analysis of 12 new-generation antidepressants showed that sertraline and escitalopram are the best in terms of efficacy and acceptability in the acute-phase treatment of adults with depression.[32] Comparative clinical trials demonstrated that sertraline is similar in efficacy against depression to moclobemide,[33] nefazodone,[34] escitalopram, bupropion,[35] citalopram, fluvoxamine, paroxetine,[32] venlafaxine,[36] and mirtazapine.[37] Sertraline may be more efficacious for the treatment of depression in the acute phase (first four weeks) than fluoxetine.[38]
There are differences between sertraline and some other antidepressants in their efficacy in the treatment of different subtypes of depression and in their adverse effects. For severe depression, sertraline is as good as
Depression in elderly
Sertraline used for the treatment of depression in elderly (older than 60) patients is superior to placebo and comparable to another SSRI fluoxetine, and
Obsessive–compulsive disorder
Sertraline is effective for the treatment of OCD in adults,[20] adolescents and children.[45][46][47] It was better tolerated and, based on intention-to-treat analysis, performed better than the gold standard of OCD treatment clomipramine.[48] Continuing sertraline treatment helps prevent relapses of OCD with long-term data supporting its use for up to 24 months.[49] The sertraline dosages necessary for the effective treatment of OCD are higher than the usual dosage for depression.[50] The onset of action is also slower for OCD than for depression. The treatment recommendation is to start treatment with a half of maximal recommended dose for at least two months. After that, the dose can be raised to the maximal recommended in the cases of unsatisfactory response.[51]
Cognitive behavioral therapy alone is not more effective than sertraline in adolescents and children; however, a combination of these treatments is effective.[47]
Panic disorder
Sertraline is superior to placebo for the treatment of
Double-blind comparative studies found sertraline to have the same effect on panic disorder as paroxetine or imipramine.[57] While imprecise, comparison of the results of trials of sertraline with separate trials of other anti-panic agents (clomipramine, imipramine, clonazepam, alprazolam, and fluvoxamine) indicates approximate equivalence of these medications.[52]
Other anxiety disorders
Sertraline has been successfully used for the treatment of social anxiety disorder.[58][59] All three major domains of the disorder (fear, avoidance, and physiological symptoms) respond to sertraline.[28] Maintenance treatment, after the response is achieved, prevents the return of the symptoms.[60] The improvement is greater among the patients with later, adult onset of the disorder.[61] In a comparison trial, sertraline was superior to exposure therapy, but patients treated with the psychological intervention continued to improve during a year-long follow-up, while those treated with sertraline deteriorated after treatment termination.[62] The combination of sertraline and cognitive behavioral therapy appears to be more effective in children and young people than either treatment alone.[63]
Sertraline has not been approved for the treatment of generalized anxiety disorder; however, several guidelines recommend it as a first-line medication referring to good quality controlled clinical trials.[64][40][49]
Premenstrual dysphoric disorder
Sertraline is effective in alleviating the symptoms of premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome.[65] Significant improvement was observed in 50–60% of cases treated with sertraline vs. 20–30% of cases on placebo. The improvement began during the first week of treatment, and in addition to mood, irritability, and anxiety, improvement was reflected in better family functioning, social activity and general quality of life. Work functioning and physical symptoms, such as swelling, bloating and breast tenderness, were less responsive to sertraline.[66][67] Taking sertraline only during the luteal phase, that is, the 12–14 days before menses, was shown to work as well as continuous treatment.[65] Continuous treatment with sub-therapeutic doses of sertraline (25 mg vs. usual 50–100 mg) is also effective.[68]
Other indications
Sertraline is approved for the treatment of
Sertraline when taken daily can be useful for the treatment of premature ejaculation.[71] A disadvantage of sertraline is that it requires continuous daily treatment to delay ejaculation significantly.[72]
A 2019 systematic review suggested that sertraline may be a good way to control anger, irritability and hostility in depressed patients and patients with other comorbidities.[73]
Contraindications
Sertraline is contraindicated in individuals taking monoamine oxidase inhibitors or the antipsychotic pimozide. Sertraline concentrate contains alcohol and is therefore contraindicated with disulfiram. The prescribing information recommends that treatment of the elderly and patients with liver impairment "must be approached with caution". Due to the slower elimination of sertraline in these groups, their exposure to sertraline may be as high as three times the average exposure for the same dose.[20]
Side effects
Nausea, ejaculation failure, insomnia, diarrhea, dry mouth, somnolence, dizziness, tremor, headache, excessive sweating, fatigue,
Over more than six months of sertraline therapy for depression, people showed no significant weight increase.[75] A 30-month-long treatment with sertraline for OCD also resulted in no significant weight gain.[76] Although the difference did not reach statistical significance, the average weight gain was lower for fluoxetine (1%) but higher for citalopram, fluvoxamine and paroxetine (2.5%). Of the sertraline group, 4.5% gained a large amount of weight (defined as more than 7% gain). This result compares favorably with placebo, where, according to the literature, 3–6% of patients gained more than 7% of their initial weight. The large weight gain was observed only among female members of the sertraline group; the significance of this finding is unclear because of the small size of the group.[76]
Over a two-week treatment of healthy volunteers, sertraline slightly improved verbal
Sertraline has a low level of exposure of an infant through the breast milk and is recommended as the preferred option for the antidepressant therapy of breast-feeding mothers.[83][84] There is 29–42% increase in congenital heart defects among children whose mothers were prescribed sertraline during pregnancy,[14][15] with sertraline use in the first trimester associated with 2.7-fold increase in septal heart defects.[14]
Abrupt interruption of sertraline treatment may result in withdrawal or discontinuation syndrome. Dizziness, insomnia, anxiety, agitation, and irritability are its common symptoms.[85] It typically occurs within a few days from drug discontinuation and lasts a few weeks.[86] The withdrawal symptoms for sertraline are less severe and frequent than for paroxetine, and more frequent than for fluoxetine.[85][86] In most cases symptoms are mild, short-lived, and resolve without treatment. More severe cases are often successfully treated by temporary reintroduction of the drug with a slower tapering off rate.[87]
Sertraline and SSRI antidepressants in general may be associated with
Sexual
Like other SSRIs, sertraline is associated with sexual side effects, including sexual arousal disorder, erectile dysfunction and difficulty achieving orgasm. While nefazodone and bupropion do not have negative effects on sexual functioning, 67% of men on sertraline experienced ejaculation difficulties versus 18% before the treatment.[91] Sexual arousal disorder, defined as "inadequate lubrication and swelling for women and erectile difficulties for men", occurred in 12% of people on sertraline as compared with 1% of patients on placebo. The mood improvement resulting from the treatment with sertraline sometimes counteracted these side effects, so that sexual desire and overall satisfaction with sex stayed the same as before the sertraline treatment. However, under the action of placebo the desire and satisfaction slightly improved.[92] Some people continue experiencing sexual side effects after they stop taking SSRIs.[93]
Suicide
The US Food and Drug Administration (FDA) requires all antidepressants, including sertraline, to carry a boxed warning stating that antidepressants increase the risk of suicide in persons younger than 25 years.[94][95][96] This warning is based on statistical analyses conducted by two independent groups of FDA experts that found a 100% increase of suicidal thoughts and behavior in children and adolescents, and a 50% increase in the 18–24 age group.[97][98][99]
Overdose
Acute overdosage is often manifested by
Interactions
As with other SSRIs, sertraline may increase the risk of bleeding with
Sertraline is a moderate
Sertraline had a slight inhibitory effect on the metabolism of diazepam, tolbutamide and warfarin, which are CYP2C9 or CYP2C19 substrates; the clinical relevance of this effect was unclear.[8] As expected from in vitro data, sertraline did not alter the human metabolism of the CYP3A4 substrates erythromycin, alprazolam, carbamazepine, clonazepam, and terfenadine; neither did it affect metabolism of the CYP1A2 substrate clozapine.[8][20][113][7]
Sertraline had no effect on the actions of digoxin and atenolol, which are not metabolized in the liver.[5] Case reports suggest that taking sertraline with phenytoin or zolpidem may induce sertraline metabolism and decrease its efficacy,[114][115] and that taking sertraline with lamotrigine may increase the blood level of lamotrigine, possibly by inhibition of glucuronidation.[116]
CYP2C19 inhibitor esomeprazole increased sertraline concentrations in blood plasma by approximately 40%.[117]
Clinical reports indicate that interaction between sertraline and the
Pharmacology
Pharmacodynamics
Site | Ki (nM) | Species | References | |
---|---|---|---|---|
SERT | 0.15–3.3 | Human | [119][120][121] | |
NET | 420–925 | Human | [119][120][121] | |
DAT | 22–315 | Human | [119][120][121] | |
5-HT1A | >35,000 | Human | [122] | |
5-HT2A | 2,207 | Rat | [121] | |
5-HT2C | 2,298 | Pig | [121] | |
α1A | 1900 | Human | [123] | |
α1B | 3,500 | Human | [123] | |
α1D | 2,500 | Human | [123] | |
α2 | 477–4,100 | Human | [120][122] | |
D2 |
10,700 | Human | [122] | |
H1 | 24,000 | Human | [122] | |
mACh |
427–2,100 | Human | [121][122][124] | |
σ1 | 32–57 | Rat | [125][126] | |
σ2 | 5,297 | Rat | [126] | |
Values are Ki (nM), unless otherwise noted. The smaller the value, the more strongly the drug binds to or inhibits the site. |
Sertraline is a
Sertraline also shows relatively high activity as an inhibitor of the dopamine transporter (DAT)[119][129][130] and antagonist of the sigma σ1 receptor (but not the σ2 receptor).[125][126][131] However, sertraline affinity for its main target (SERT) is much greater than its affinity for σ1 receptor and DAT.[118][119][126][125] Although there could be a role for the σ1 receptor in the pharmacology of sertraline, the significance of this receptor in its actions is unclear.[31] Similarly, the clinical relevance of sertraline's blockade of the dopamine transporter is uncertain.[119]
Pharmacokinetics
Absorption
Following a single oral dose of sertraline, mean peak blood levels of sertraline occur between 4.5 and 8.4 hours.
Distribution
Sertraline is highly plasma protein bound (98.5%) across a concentration range of 20 to 500 ng/mL.[5] Despite the high plasma protein binding, sertraline and its metabolite desmethylsertraline at respective tested concentrations of 300 ng/mL and 200 ng/mL were found not to interfere with the plasma protein binding of warfarin and propranolol, two other highly plasma protein-bound drugs.[5]
Metabolism
Sertraline is subject to extensive
Elimination
The
In a small study of two males, sertraline was excreted to similar degrees in urine and feces (40 to 45% each within 9 days).[5] Unchanged sertraline was not detectable in urine, whereas 12 to 14% unchanged sertraline was present in feces.[5]
Pharmacogenomics
History
The history of sertraline dates back to the early 1970s, when
Sertraline was approved by the US Food and Drug Administration (FDA) in 1991 based on the recommendation of the Psychopharmacological Drugs Advisory Committee; it had already become available in the United Kingdom the previous year.[141] The FDA committee achieved a consensus that sertraline was safe and effective for the treatment of major depression. During the discussion, Paul Leber, the director of the FDA Division of Neuropharmacological Drug Products, noted that granting approval was a "tough decision", since the treatment effect on outpatients with depression had been "modest to minimal". Other experts emphasized that the drug's effect on inpatients had not differed from placebo and criticized poor design of the clinical trials by Pfizer.[142] For example, 40% of participants dropped out of the trials, significantly decreasing their validity.[143]
Until 2002, sertraline was only approved for use in adults ages 18 and over; that year, it was approved by the FDA for use in treating children aged 6 or older with severe OCD. In 2003, the UK Medicines and Healthcare products Regulatory Agency issued a guidance that, apart from fluoxetine (Prozac), SSRIs are not suitable for the treatment of depression in patients under 18.[144][145] However, sertraline can still be used in the UK for the treatment of OCD in children and adolescents.[146] In 2005, the FDA added a boxed warning concerning pediatric suicidal behavior to all antidepressants, including sertraline. In 2007, labeling was again changed to add a warning regarding suicidal behavior in young adults ages 18 to 24.[147]
Society and culture
Generic availability
The US patent for Zoloft expired in 2006,[148] and sertraline is available in generic form and is marketed under many brand names worldwide.[1]
In May 2020, the FDA placed Zoloft on the list of drugs currently facing a shortage.[149]
Interest during COVID-19 pandemic
Sertraline has been the most sought-after antidepressant worldwide before, during, and after the COVID-19 pandemic, according to Google Trends data. The pandemic has led to an increase in searches for antidepressants, with sertraline, fluoxetine, duloxetine, and venlafaxine showing the highest search volumes, whereas searches of citalopram decreased during the pandemic.[150]
Other uses
Sertraline may be useful to treat
Lass-Flörl et al., 2003 finds it significantly inhibits phospholipase B in the fungal genus Candida, reducing virulence.[152]
Sertraline is also a very effective leishmanicide.
Sertraline is strongly
Lass-Flörl et al., 2003 finds this compound acts as a fungicide against Candida parapsilosis.[155] Its anti-Cp effect is indeed due to its serotonergic activity and not its other effects.[155]
Sertraline is a promising
See also
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