How do antidepressants like Zoloft affect sweating. What are the risks of excessive sweating from SSRIs during hot weather. How can patients manage antidepressant-induced hyperhidrosis and stay comfortable.

The Link Between Antidepressants and Excessive Sweating

Many people taking antidepressants like Zoloft (sertraline) experience increased sweating as a side effect. This phenomenon, known as antidepressant-induced hyperhidrosis, can affect up to 15% of patients on these medications. While the exact mechanism is not fully understood, it’s believed to be related to how antidepressants influence serotonin and body temperature regulation.

Tricyclic antidepressants and selective serotonin reuptake inhibitors (SSRIs) like Zoloft are the most common culprits behind excessive sweating. The increased serotonin activity appears to overstimulate the body’s cooling mechanisms, leading to excess perspiration even in normal temperatures.

Why Do Antidepressants Cause Sweating?

The primary theory is that antidepressants affect the body’s thermoregulation by altering serotonin levels. As Dr. Kandi Ejiofor explains, “The way in which antidepressants cause excessive sweating is still relatively unknown – it is thought to be linked to the effects of serotonin, the happy hormone, in trying to maintain the internal core temperature of the body. Your body sweats to try and cool down the body but overstimulation of this process can lead to overheating and excess sweating.”

Risks of Antidepressant-Induced Sweating in Hot Weather

During heatwaves or hot weather, individuals taking antidepressants may be at higher risk of heat-related illnesses due to their increased tendency to sweat and feel overheated. This can potentially lead to:

• Dehydration
• Heat exhaustion
• Heat stroke
• Heat rash
• General discomfort

It’s crucial for patients on antidepressants to be extra vigilant about staying hydrated and cool during hot spells. The combination of medication-induced sweating and high temperatures can quickly lead to fluid loss and overheating if proper precautions aren’t taken.

Serotonin Syndrome: A Rare But Serious Risk

In rare cases, excessive sweating could be a sign of serotonin syndrome, a potentially dangerous condition caused by too much serotonin activity in the brain. Dr. Stephanie Ooi warns that hot weather could mask some symptoms of this syndrome, which can occur if SSRIs are combined with other serotonin-increasing substances.

Symptoms of serotonin syndrome to watch for include:

• Confusion
• Agitation
• Muscle twitching
• Shivering
• Diarrhea
• Excessive sweating

While serotonin syndrome is uncommon, it’s important to be aware of the symptoms and seek medical attention if they occur, especially during hot weather when some signs might be attributed to heat.

Managing Antidepressant-Induced Hyperhidrosis

If you’re experiencing excessive sweating due to antidepressants like Zoloft, it’s essential to address the issue rather than discontinuing your medication. Abruptly stopping antidepressants can lead to withdrawal symptoms and a recurrence of depression. Instead, consider these strategies for managing antidepressant-induced sweating:

Consult Your Healthcare Provider

Your doctor may be able to adjust your medication or prescribe additional treatments to help manage excessive sweating. Options might include:

• Switching to a different antidepressant with a lower risk of hyperhidrosis
• Prescribing anticholinergic medications like oxybutynin to reduce sweating
• Recommending topical treatments or antiperspirants

Monitor Your Body Temperature

Dr. Kandi suggests using a thermometer to regularly check your body temperature, especially during hot weather. If your core temperature is consistently elevated, inform your doctor for appropriate management.

Stay Hydrated

Drink plenty of water throughout the day to replace fluids lost through sweating. Carry a water bottle with you and sip regularly, especially in hot environments or during physical activity.

Dress Appropriately

Choose loose-fitting clothing made from breathable fabrics like cotton or linen. Avoid tight clothes and synthetic materials that can trap heat and moisture against your skin.

Avoid Sweat Triggers

Certain foods, drinks, and activities can exacerbate sweating. Try to limit or avoid:

• Spicy foods
• Caffeine
• Alcohol
• Hot beverages
• Intense physical activity, especially in hot weather

Lifestyle Adjustments for Coping with Antidepressant-Induced Sweating

In addition to medical interventions, several lifestyle changes can help manage excessive sweating caused by antidepressants:

Create a Cool Environment

Use fans, air conditioning, or open windows to maintain a comfortable temperature in your living and working spaces. Consider using a dehumidifier to reduce moisture in the air, which can make sweating feel more pronounced.

Practice Stress-Reduction Techniques

Stress and anxiety can trigger or worsen sweating. Incorporate relaxation methods into your daily routine, such as:

• Deep breathing exercises
• Meditation
• Yoga
• Progressive muscle relaxation

Use Cooling Products

Invest in products designed to help you stay cool and comfortable:

• Cooling towels or bandanas
• Moisture-wicking clothing
• Bed sheets made from cooling fabrics
• Personal handheld fans

Maintain Good Hygiene

Regular bathing and use of antiperspirants can help manage body odor associated with excessive sweating. Consider using antibacterial soaps and applying antiperspirant at night for better effectiveness.

The Impact of Antidepressant-Induced Sweating on Quality of Life

Excessive sweating caused by antidepressants like Zoloft can significantly impact a person’s quality of life. It may lead to:

• Social anxiety and embarrassment
• Discomfort in professional settings
• Skin irritation or infections
• Disrupted sleep due to night sweats
• Increased laundry and clothing expenses

These effects can be particularly challenging for individuals already dealing with depression or anxiety. It’s important to address these concerns with your healthcare provider to find a balance between managing your mental health and minimizing side effects.

Emerging Treatments for Antidepressant-Induced Hyperhidrosis

Research into managing antidepressant-induced sweating is ongoing, with several promising treatments on the horizon:

Botulinum Toxin Injections

Botox injections have shown effectiveness in treating localized hyperhidrosis and may be an option for some patients with antidepressant-induced sweating.

Microwave Thermolysis

This non-invasive treatment uses microwave energy to destroy sweat glands in specific areas, potentially providing long-lasting relief from excessive sweating.

Newer Antidepressants

Pharmaceutical companies are developing new antidepressants with different mechanisms of action that may have a lower risk of causing hyperhidrosis.

When to Seek Medical Attention for Antidepressant-Induced Sweating

While some degree of increased sweating is common with antidepressants, certain situations warrant immediate medical attention:

• Sudden onset of excessive sweating, especially if accompanied by other symptoms like fever or chest pain
• Signs of dehydration, such as dark urine, dizziness, or rapid heartbeat
• Development of skin infections or persistent rashes in areas of excessive sweating
• Sweating that significantly interferes with daily activities or sleep
• Any symptoms suggestive of serotonin syndrome

Never hesitate to contact your healthcare provider if you’re concerned about the effects of your antidepressant medication, including excessive sweating. They can help determine if your symptoms are within the normal range or if adjustments to your treatment plan are necessary.

The Future of Managing Antidepressant Side Effects

As our understanding of depression and antidepressant medications continues to evolve, researchers are working on developing new approaches to minimize side effects like excessive sweating. Some areas of focus include:

Personalized Medicine

Genetic testing and biomarker analysis may help predict which patients are more likely to experience certain side effects, allowing for more tailored treatment approaches.

Novel Drug Delivery Systems

New methods of delivering antidepressants, such as transdermal patches or long-acting injectables, may help reduce side effects by providing more consistent drug levels in the body.

Combination Therapies

Combining lower doses of multiple medications or integrating non-pharmacological treatments may help achieve the desired antidepressant effect while minimizing side effects like hyperhidrosis.

As research progresses, patients and healthcare providers can look forward to more options for effectively managing depression while minimizing uncomfortable side effects like excessive sweating.

Antidepressants can cause excess sweating and overheating – how to cope

Feeling the heat? Your medication might be to blame (Picture: Getty/Metro.co.uk)

Yes, it is extremely hot right now.

But if you’ve noticed that you’re sweating more than you ever have before, there might be another reason: your antidepressants.

Many antidepressants increase your likelihood of excessive sweating, known as hyperhidrosis.

It’s not clear why mental health medication can trigger a major case of sweaty upper lip syndrome, but the good news is that if you are experiencing this, you’re certainly not alone – and there are ways to reduce the struggles.

Let’s get into it.

Why do antidepressants make you sweat more?

‘The majority of antidepressants increase the risk of hyperhidrosis,’ explains Dr Kandi Ejiofor. ‘Some American studies cite that excess sweating can affect up to 15% of people take antidepressants.

‘Specifically, Tricyclic Acid and SSRI (selective serotonin reuptake inhibitors) antidepressants are responsible for this.

‘The way in which antidepressants cause excessive sweating is still relatively unknown – it is thought to be linked to the effects of serotonin, the happy hormone, in trying to maintain the internal core temperature of the body.

‘Your body sweats to try and cool down the body but overstimulation of this process can lead to overheating and excess sweating.’

What risks do antidepressants pose in hot weather?

In the current heatwave, some people who are taking antidepressants will notice not only more sweating than usual, but also simply feeling the heat more.

This can then lead to dehydration, heat stroke, heat rash, and other heat related issues, so it’s essential that you’re really on top of all the regular hot-weather-related care, such as drinking plenty of water, taking time out of the sun, and avoiding overexertion.

Dr Stephanie Ooi, GP at MyHealthcare Clinic, notes that the hot weather could also disguise the symptoms of serotonin syndrome, a rare, but potentially serious set of side effects that are linked to SSRIs

‘Serotonin syndrome occurs when the levels of serotonin in your brain are too high,’ says Dr Stephanie. ‘This can occur if you take an SSRI in combination with something else that also raises serotonin levels, such as another antidepressant or St John’s Wort.’

Symptoms of serotonin syndrome can include:

• confusion
• agitation
• muscle twitching
• sweating
• shivering
• diarrhoea

That is unlikely, by the way. The main risks you’ll face in the UK heatwave when taking antidepressants are the minor, but annoying ones: feeling super sweaty, hot, and uncomfortable.

This poses a greater risk though: that you might get so fed up of being covered in sweat that you stop taking your medication in an attempt to lower your temperature.

This is not a good idea.

‘Sweating secondary to antidepressant medication is usually not a cause for concern on its own but the symptoms can be so bothersome that it causes people to stop taking their medication, which of course could be problematic,’ says Dr Kandi.

Your GP might be able to help tackle the sweaty effects of your meds (Picture: Getty Images/iStockphoto)

What should you do if your antidepressants are causing excess sweating?

First things first: keep taking your meds. Don’t do a sudden stop out of desperation to cool down.

Instead, it’s worth talking to your GP if hyperhidrosis is negatively affecting your life.

‘They may consider prescribing you another medication to counteract the effects of the medication you are on,’ suggests Dr Kandi.

Along with this, there are many things you can do on your own to reduce any hot weather induced discomfort.

Measure your temperature

Dr Kandi recommends investing in a thermometer, so you can regularly measure your temperature and thus know when there’s a problem.

‘If your core temperature is consistently raised above the baseline, it is worthwhile discussing with your doctor to review you and manage your symptoms appropriately,’ she notes.

Drink plenty of fluids

Make sure you’re sipping water throughout the day, carrying a bottle with you wherever you go.

This is key to avoid dehydration, especially if you’re losing a lot of fluid from excess sweating.

Take it easy

Now might not be a great time to rush around doing loads of things at once, or to do super intense workouts. Give yourself plenty of rest and prioritise keeping cool.

Wear the right clothes

‘Wear loose clothing in breathable materials such as cotton or linen,’ Dr Stephanie suggests. ‘Avoid tight clothing or synthetic materials.’

More: Health

Avoid other triggers for increased sweating

Drinking alcohol and eating spicy food can make your sweating worse.

Get a good antiperspirant

Speak to your pharmacist about one that will work best for excess sweating.

You can also buy armpit or sweat shields if you’re worried about protecting your clothing.

Prioritise lowering stress and anxiety

You know the drill: you sweat, then you get self-conscious and panic about sweating, then you sweat more, and so the awful cycle continues.

Remind yourself that sweating is perfectly natural, and people will understand – it’s boiling right now, so we doubt anyone is judging you for perspiring.

In moments when your excess stress is bothering you, try to ground yourself and do breathing exercises to slow your heartrate and bring you back to a place of calm.

Do you have a story to share?

Get in touch by emailing [email protected].

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Does Zoloft Cause Night Sweats? (5 Things You Need To Know)

In this blog, we will learn about zoloft induced night sweats. We will also discuss the reason behind it and how to overcome this condition. If you’ve noticed you are sweating more than usual, you need to take a look at your medication list.

Does zoloft cause night sweats?

Yes, zoloft is associated with many side effects, one of which is excessive sweating at night, called ‘night sweats’. In fact, zoloft induced night sweats are one of the most disturbing side effects. 

The thought of sweating profusely, in the might of the night, even during winters, is quite disturbing. Zoloft not only causes excessive sweating at night, but at any part of the day. 

Not only zoloft, a lot of other antidepressants do the same. Zoloft belongs to the class of SSRIs. SSRIs increase serotonin levels in the brain. Serotonin can affect hypothalamus, which is responsible for regulating your homeostasis. 

It can have an impact on your body temperature and your ability to sweat. Abnormal sweating, is in fact, a very common side effect of SSRI antidepressants, occurring in around 10–20% of patients. It usually sticks around, or even worsens. 

Antidepressant-induced sweating is different for everyone. For some people, it is so severe that they need to find a different drug, or quit antidepressants altogether.  

Is zoloft induced excessive sweating that bad?

Excessive sweating is quite problematic. In short, it is disabling. It affects the quality of life as it ends up disturbing people more than they could imagine. It becomes socially embarrassing for them, and in some cases, they are embarrassed in front of their spouses as well. 

Imagine snowing outside, literally it’s that cold. You wake up in the middle of the night just to find out that you’re sweating profusely. It not only ruins your sleep quality, but also your hygiene as well.

Zoloft induced sweating is more prominent in the upper body, face, scalp, neck and chest. Do not wait for it to subside on its own. This does not go away that easy. 

What could be done? 

If the night sweats are disrupting your life that terribly, one of the few things might help:

Dose reduction

Dose reduction can be considered, if possible. If there’s a chance of your condition worsening with a lower dose, then this option is not so helpful. But if there is a chance to minimise side effects by reducing the dose, without affecting the therapeutic response, this might help. 

Consider changing antidepressant

If feasible, you can switch to a different SSRI or any other class of antidepressant (except bupropion, which has a higher rate of night sweats as compared to any other antidepressant). 

For example, if zoloft (Sertraline) is inducing night sweats in you, ask your healthcare provider to prescribe another antidepressant of the same family (SSRIs), which might help you with depression without inducing excessive sweating. 

Give your body time

Your body might need some time to adapt to the presence of zoloft. These meds affect your brain and alter the amounts of excitatory neurotransmitters, to get rid of your anxiety and depression. It can not happen overnight. 

Side effects associated with zoloft start to fade away within a few weeks. Make sure you give your body enough time to adjust. Do not stop your med abruptly.

What if it gets worse?

If your night sweats get worse and even after weeks of treatment, this side effect persists, your healthcare provider may prescribe some medical treatment to overcome your night sweats. Medications used to reduce excessive sweating include:

TERAZOSIN 

Terazosin is an alpha-1 adrenergic antagonist, generally used in the treatment of symptomatic benign prostatic hyperplasia and management of hypertension. 

In a study conducted in 2013, it was observed that in the beginning of the study, 48.5% patients suffered from high grade sweating. After 14 days of treatment with terazosin, the percentage reduced down by half.

This concludes that terazosin is effective in decreasing sweating severity in patients using zoloft (Sertraline).

Side effects of terazosin 

As it’s nothing new to know that every medicine has its own side effects. Let’s take a look at side effects associated with the use of terazosin.  

• Chest tightness and pain
• Dizziness/lightheadedness/vertigo
• Shortness of breath.
• Unconsciousness 
• Arrhythmia or irregular heartbeat.
• Swelling of lower extremities
• Impotence (inability to have an erection)
• Blurred vision
• Nausea
• Stuffy or runny nose

One thing that I always try to tell my readers is, every human body is different, and no I don’t mean physically or the way we look, I mean internally! Just like every human being reacts differently to different situations.

Similarly every human body reacts differently when they are exposed to medications. Every single individual out there has a different physiological composition. A certain medicine might be beneficial for one but ends up producing serious side effects in another. 

GLYCOPYRROLATE AND OXYBUTYNIN

Glycopyrrolate and Oxybutynin are also known as ‘The sweat pills’. Glycopyrrolate (sold under the brand name Robinul) is one of the anticholinergics used most often in the treatment of excessive sweating.  

The effectiveness of glycopyrrolate is often related to the dose a patient is able to handle, and obviously how the patient responds to the drug. Studies suggest that glycopyrrolate reduces sweating efficiently but it is not tolerated by some people because of its side effects.

Side effects of Glycopyrrolate 

Side effects include:

• Dry mouth (the most common side effect) 
• Dry eyes or decreased lacrimation
• Constipation
• Nausea 

Drinking more water, mints, eye-drops and increased fibre consumption might help fight these side effects.

Fear of serotonin syndrome 

Yes, it is very important to rule out serotonin syndrome as sometimes, you think that excessive sweating is a side effect you’re getting from the use of zoloft, but what if it’s something else? 

Serotonin syndrome (SD), also known as serotonin toxicity, is a potentially life threatening condition involving excessive serotonergic activation. It has many symptoms to talk about.  

The basic cause of this condition is the serotonin overload and the antidepressants are considered the main culprit for this condition. The syndrome is pretty rare, so it is unlikely to occur when a patient is sticking to the dose recommended by the healthcare provider.

Sometimes, they combine the use of these types of medications, for the sake of achieving better results, so if you are already on a stable dose but you combine zoloft with other medications. 

Other non psychological medications, which somehow increase the amount of serotonin in the body, it also results in serotonin syndrome. 

For example, if selene, which is a Parkinson’s disease medication, is also added on a patient when a patient is already on zoloft, it increases the risk for serotonin syndrome. 

Now, let’s briefly talk about the path of physiology behind this condition. It all begins with the amino acid tryptophan, which is used to produce serotonin. 

It actually undergoes a couple of enzymatic reactions and ends up producing serotonin, which can act on a variety of different receptors in the brain to modulate mood, appetite, sleep and attention but it also has other regulatory functions in the body.  

One of the main symptoms of serotonin syndrome is profuse sweating, which is why I had to mention this condition, as oftentimes it is not even a side effect of zoloft but an actual syndrome, and the patient has no clue of it. 

Signs and symptoms of serotonin syndrome 

• Excessive sweating 
• Restlessness and fatigue
• Headache, which often feels like your head is pounding
• Changes in blood pressure and/or temperature
• Nausea
• Vomiting
• Diarrhoea
• Bradycardia
• Tremors
• Muscle twitching and muscle pain
• Shivering and goosebumps

Conclusion

Zoloft, an antidepressant, is often seen to be associated with profuse sweating, especially at night. This is indeed a pretty depressing condition, as it decreases the quality of life. 

In this blog, we discussed the options you have if you’re going through this problem. You can either reduce the dose or change the kind of antidepressant you’re on right now. If that doesn’t solve your problem, then terazosin and glycopyrrolate are prescribed to take your excessive sweating down a notch. 

In the end, always look out for serotonin syndrome. Immediately notify your healthcare provider, if you feel excessively increased heartbeat, chills and fever along with sweating. 

FAQs : Zoloft night sweats 

How long do night sweats last with Zoloft?

It depends on the dose you’re prescribed. Antidepressants usually take 4 to 6 weeks to produce their effects, as well as side effects. Most probably, these side effects subside when your body adapts to the presence of the med. 

Some side effects don’t. Make sure you discuss the do’s and don’ts with your healthcare provider. 

Why do antidepressants cause night sweats?

SSRIs induce sweating by blocking muscarinic receptors. Abnormal sweating, is in fact, a very common side effect of SSRI antidepressants, occurring in around 10–20% of patients. 

It usually sticks around, or even worsens. Antidepressant-induced sweating can take various forms, one of which is night sweats.

For some patients, the antidepressant-induced sweating is so severe that they need to find a different drug, or quit antidepressants altogether.

How do I stop night sweats from antidepressants?

As we have discussed in this blog, dose reduction can be considered, if possible. If there’s a chance of your condition worsening with a lower dose, then this option is not so helpful. But if there is a chance of doing so, this might help. 

Consider changing your antidepressant, if feasible. You can switch to a different SSRI or any other class of antidepressant (except bupropion, which has a higher rate of night sweats as compared to any other antidepressant).

In severe cases, terazosin or glycopyrrolate are recommended. 

Can paroxetine cause night sweats?

Yes, it can. Paroxetine is a member of SSRIs family. Its side effect profile is somewhat similar to other members of this class of antidepressants. Make sure you don’t exceed the recommended dose. 

What are the most common side effects of Zoloft?

Most common side effects include nausea, dizziness, drowsiness, dry mouth, loss of appetite, increased sweating, diarrhoea, upset stomach, trouble sleeping, weight gain and decreased libido. 

Nausea and vomiting may be more likely to occur with initial use of zoloft. It improves over time when the body starts to accept it. Within a few weeks, gastrointestinal side effects subside. 

Always remember, the proper use of medicines is the key to their maximum beneficial effect. Avoid deviating from the dose suggested by your healthcare provider, and never stop it abruptly.

References 

• James W. Mold and Barbara J. Holtzclaw – Selective Serotonin Reuptake Inhibitors and Night Sweats in a Primary Care Population https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4883206/
• Pilot Study of Terazosin in Treatment of Antidepressant Induced Excessive Sweating https://clinicaltrials. gov/ct2/show/NCT00237510
• Ali Ghaleiha et al. Int J Psychiatry Clin Pract. 2013 – Effect of terazosin on sweating in patients with major depressive disorder receiving sertraline: a randomized controlled trial https://pubmed.ncbi.nlm.nih.gov/22731399/
• Rajnish Mago et al. Ann Clin Psychiatry. 2013 – Antidepressant-induced excessive sweating: clinical features and treatment with terazosin https://pubmed.ncbi.nlm.nih.gov/23638448/
• Hyun Ho Lee, MD, Do Won Kim, MD. Efficacy of Glycopyrrolate in Primary Hyperhidrosis Patients https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3259134/

official instructions for use, analogues, price, availability in pharmacies

Registration number :

Trade name : Zoloft ^® / Zoloft ^® 90 005

International (nonproprietary) name (INN) : Sertraline /Sertraline

Chemical name – cis-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthaleneamine

Dosage form : film-coated tablets.

Composition

Active ingredient: sertraline hydrochloride at a dose corresponding to 50 mg or 100 mg sertraline.
Excipients: calcium phosphate, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol, polysorbates, titanium dioxide (E171).

Description : white oblong tablets. On the surface of the tablet, “Pfizer” is squeezed out on one side, on the other side for a dosage of 50 mg “ZLT-50” (with a risk), for a dosage of 100 mg – “ZLT-100”.

Pharmacotherapeutic group:

antidepressant; ATX code N06AB06

Pharmacodynamic properties

Sertraline is an antidepressant, a powerful specific inhibitor of serotonin (5-HT) reuptake in neurons. It has very little effect on the reuptake of norepinephrine and dopamine. At therapeutic doses, sertraline blocks the uptake of serotonin in human platelets. It has no stimulant, sedative or anticholinergic effect. Due to selective inhibition of 5-HT uptake, sertraline does not enhance adrenergic activity. Sertraline has no affinity for muscarinic (cholinergic), serotonergic, dopaminergic, adrenergic, histaminergic, GABA or benzodiazepine receptors. Sertraline does not cause drug dependence, does not cause an increase in body weight with long-term use.

Pharmacokinetic properties

Absorption – high (but at a slow rate). Bioavailability is increased by 25% during meals. Food increases the maximum concentration (Cmax) by 25% and shortens the time to reach the maximum concentration (Tcmax). In humans, when treated with sertraline at a dose of 50 to 200 mg once a day for 14 days, the plasma concentration of the drug reached a peak (Cmax) 4.5-8.4 hours after administration. Cmax and the area under the concentration-time curve (AUC) are proportional to the dose in the range of 50-200 mg of sertraline 1 time per day for 14 days, while a linear pharmacokinetic dependence is revealed. The pharmacokinetic profile in adolescents and the elderly does not differ significantly from that in patients aged 18 to 65 years. The mean half-life (T1 / 2) of sertraline in young and elderly men and women is 22-36 hours. According to the final T1 / 2, approximately two-fold accumulation of the drug is observed before equilibrium concentrations are reached after 1 week of treatment (dose once a day). Plasma protein binding is approximately 98%. The pharmacokinetics of sertraline in children with OCD (see below) has been shown to be similar to that in adults (although sertraline metabolism is somewhat more active in children). However, given the lower body weight in children (especially those aged 6-12 years), the drug is recommended to be used at a lower dose in order to avoid excessive plasma levels.
Sertraline undergoes active biotransformation during the first passage through the liver. The main metabolite found in plasma, N-desmethylsertraline, is significantly inferior (about 20 times) to sertraline in activity in vitro and is actually not active in models of depression in vivo. T1 / 2 N-desmethylsertraline varies within 62-104 hours. Sertraline and N-desmethylsertraline are actively biotransformed; the resulting metabolites are excreted in equal amounts with feces and urine. Unchanged sertraline is excreted in the urine in small amounts (<0.2%). In patients with cirrhosis of the liver, T1 / 2 of the drug and AUC increase compared to those in healthy people.

Indications for use

Depression of various etiologies (treatment and prevention), Obsessive-compulsive disorders (OCD) Panic disorders.
Post-traumatic stress disorder (PTSD). social phobia.

Contraindications

Known hypersensitivity to sertraline, children under 6 years of age, pregnancy and breastfeeding (see section Pregnancy and breastfeeding). The drug should not be administered to patients simultaneously receiving monoamine oxidase inhibitors (MAOIs) and pimozide. With caution: organic diseases of the brain (including mental retardation), epilepsy, liver and / or kidney failure, marked weight loss.
Pregnancy and breastfeeding: There are no controlled results from the use of sertraline in pregnant women, so it is worth prescribing the drug to them only if the expected benefit to the mother outweighs the potential risk to the fetus. Women of reproductive age who are to be prescribed sertraline should be advised to use effective contraception.
Sertraline is found in breast milk, and therefore, treatment with this drug during breastfeeding is not recommended. There is no reliable data on the safety of its use in this case. If treatment is still necessary, then it is better to stop breastfeeding. In the case of the use of sertraline during pregnancy and lactation, some newborns whose mothers took antidepressants from the group of selective serotonin reuptake inhibitors (SSRIs), including serotonin, may experience symptoms similar to the reaction to drug withdrawal.

Side effect

Digestive system: dyspeptic disorders (flatulence, nausea, vomiting, diarrhea, constipation), abdominal pain, pancreatitis, dry mouth.
Cardiovascular system: palpitations, tachycardia, arterial hypertension.
Musculoskeletal system: arthralgia, muscle cramps.
Central and peripheral nervous system: extrapyramidal disorders (dyskinesias, akathisias, teeth grinding, gait disturbance), involuntary muscle contractions, paresthesias, syncope, drowsiness, headache, migraine, dizziness, tremor, insomnia, anxiety, agitation, hypomania, mania, hallucinations, euphoria, nightmares, psychosis, decreased libido, suicide, coma.
Respiratory system: bronchospasm, yawning.
Urinary system: enuresis, incontinence or urinary retention.
Reproductive system and mammary gland: sexual dysfunction (delayed ejaculation, reduced potency), galactorrhea, gynecomastia, menstrual disorders, priapism.
Organs of vision : blurred vision, mydriasis.
Endocrine system: hyperprolactinemia, hypothyroidism, syndrome of inappropriate ADH secretion.
Hepatobiliary system: hepatitis, jaundice, liver failure.
Allergic reactions: urticaria, pruritus, anaphylactoid reaction.
Other: weakness, reddening of the skin or flushing of the face, ringing in the ears, alopecia, angioedema, swelling of the face, periorbital edema, photosensitivity reaction, purpura, increased sweating, decreased appetite (rarely increased), up to anorexia, decrease or increase in body weight, bleeding (including nasal, gastrointestinal or hematuria), peripheral edema, occasionally Steven-Johnson syndrome and epidermal necrolysis.
Laboratory data: rarely, with prolonged use, an asymptomatic increase in serum transaminase activity occurs. Cancellation of the drug in this case leads to the normalization of enzyme activity. Perhaps the development of leukopenia and thrombocytopenia, as well as an increase in the level of cholesterol in the blood serum. With the termination of treatment with sertraline, rare cases of withdrawal syndrome have been described. Paresthesias, hypesthesias, symptoms of depression, hallucinations, aggressive reactions, psychomotor agitation, anxiety, or symptoms of psychosis that cannot be distinguished from the symptoms of the underlying disease may appear.

Overdose

Sertraline overdose did not cause severe symptoms even when the drug was administered in high doses. However, with simultaneous administration with other drugs or alcohol, severe poisoning can occur, up to coma and death. Overdose can cause serotonin syndrome with nausea, vomiting, drowsiness, tachycardia, agitation, dizziness, psychomotor agitation, diarrhea, increased sweating, myoclonus and hyperreflexia. Treatment: There are no specific antidotes. Intensive maintenance therapy and constant monitoring of vital body functions are required. Inducing vomiting is not recommended. The introduction of activated charcoal may be more effective than gastric lavage. The airway must be maintained. Sertraline has a large volume of distribution, and therefore increased diuresis, dialysis, hemoperfusion, or blood transfusion may be ineffective.

Interaction with other drugs

Pimozide – With the combined use of sertraline and pimozide, an increase in the levels of pimozide was noted when it was administered once at a low dose (2 mg). The increase in pimozide levels was not associated with any ECG changes. Since the mechanism of this interaction is not known, and pimozide has a narrow therapeutic index, the simultaneous use of pimozide and sertraline is contraindicated.
Monoamine oxidase inhibitors (MAOIs). Severe complications have been noted with the simultaneous use of sertraline and MAOIs (including selectively acting (selegiline) MAOIs and with a reversible type of action (moclobemide, as well as linezolid). Serotonin syndrome may develop (hyperthermia, rigidity, myoclonus, lability of the autonomic nervous system (rapid fluctuations in parameters respiratory and cardiovascular system), changes in mental status, including increased irritability, marked agitation, confusion, which in some cases can turn into a delirious state or coma). Similar complications, sometimes fatal, occur when MAOIs are prescribed during treatment with antidepressants, inhibiting neuronal uptake of monoamines or immediately after their withdrawal.0029 Central nervous system depressants and ethanol.

The combined use of sertraline and substances that depress the central nervous system requires close attention, and the use of alcoholic beverages and preparations containing alcohol during treatment with sertraline is prohibited. There was no potentiation of the effect of ethanol, carbamazepine, haloperidol or phenytoin on cognitive and psychomotor function in healthy people; however, co-administration of sertraline and alcohol is not recommended.
Indirect anticoagulants (earfarin) – when they are co-administered with sertraline, there is a slight, but statistically significant increase in prothrombin time – in these cases, it is recommended to control prothrombin time at the beginning of treatment with sertraline and after its withdrawal.

Special instructions

Sertraline should not be co-administered with an MAOI or for 14 days after stopping MAOI treatment. Similarly, after the abolition of sertraline, MAOIs are not prescribed for 14 days.
Serotonin syndrome and neuroleptic malignant syndrome

When using selective serotonin reuptake inhibitors (SSRIs), cases of serotonin syndrome (SS) and neuroleptic malignant syndrome (NMS) have been described, the risk of which increases when SSRIs are combined with other serotonergic drugs (including triptans), as well as drugs that affect serotonin metabolism (including monoamine oxidase inhibitors), antipsychotics and other dopamine receptor antagonists. Manifestations of SS may include changes in mental status (in particular, agitation, hallucinations, coma), autonomic lability (tachycardia, fluctuations in blood pressure, hyperthermia), changes in neuromuscular transmission (hyperreflexia, impaired coordination of movements) and / or disorders of the gastrointestinal tract. intestinal tract (nausea, vomiting and diarrhea). Some manifestations of SS, including hyperthermia, muscle rigidity, autonomic lability with the possibility of rapid fluctuations in vital signs, and changes in mental status, may resemble the symptoms that develop in NMS. It is necessary to monitor patients for the development of clinical manifestations of SS and NMS.
Other serotonergic agents – Caution should be exercised when sertraline is co-administered with other drugs that enhance serotonergic neurotransmission, such as tryptophan, fenfluramine, or 5-HT agonists. Such co-administration, if possible, should be excluded, given the likelihood of pharmacodynamic interaction.
Switching from other selective serotonin reuptake inhibitors (SSRIs), antidepressants or anti-obsessional drugs. The experience of clinical studies, the purpose of which was to determine the optimal time required for the transfer of patients from other antidepressant and anti-obsessional drugs to sertraline, is limited. Care must be taken when switching, especially from long-acting drugs such as fluoxetine. The necessary interval between the abolition of one selective serotonin reuptake inhibitor and the start of another similar drug has not been established. It should be noted that there is no sufficient experience with sertraline in patients undergoing electroconvulsive therapy.
The possible success or risk of such combined treatment has not been studied. There is no experience with the use of sertraline in patients with convulsive syndrome, so its use in patients with unstable epilepsy should be avoided, and patients with controlled epilepsy should be carefully monitored during treatment. If convulsions occur, the drug should be discontinued. Patients suffering from depression are at risk for suicidal attempts. This danger persists until remission develops. Therefore, from the beginning of treatment until the achievement of the optimal clinical effect, patients should be under constant medical supervision.
Mania/hypomania activation. During clinical trials prior to the introduction of sertraline to the market, hypomania and mania were observed in approximately 0.4% of patients receiving sertraline. Cases of activation of mania/hypomania are also described in a small proportion of patients with manic-depressive psychosis treated with other antidepressant or anti-obsessional drugs.
Use in liver failure. Sertraline is actively biotransformed in the liver. According to a pharmacokinetic study, with repeated administration of sertraline in patients with stable cirrhosis of the lung, an increase in the half-life of the drug and an almost threefold increase in AUC (area under the concentration/time curve) and maximum concentration of the drug were observed compared with those in healthy people. There were no significant differences in plasma protein binding between the two groups. Sertraline should be used with caution in patients with liver disease. When prescribing the drug to a patient with impaired liver function, it is necessary to discuss the advisability of reducing the dose or increasing the interval between taking the drug.
Use in renal failure

Sertraline undergoes active biotransformation, therefore, unchanged in the urine, it is excreted in small quantities. In patients with mild to moderate renal insufficiency (creatinine clearance 30-60 ml / min) and patients with moderate or severe renal insufficiency (creatinine clearance 10-29 ml / min), pharmacokinetic parameters (AUC0-24 and Cmax) of sertraline with repeated its intake did not differ significantly from the control group. In all groups, the half-life of the drug was the same, as well as there were no differences in plasma protein binding. The results of this study suggest that, as expected given the negligible renal excretion of sertraline, no dosage adjustment is required based on the severity of renal impairment.
Pathological bleeding/hemorrhage

Caution is advised when prescribing selective serotonin reuptake inhibitors in combination with drugs that have an established ability to alter platelet function, as well as in patients with a history of hemorrhagic diseases.
Hyponatremia

Transient hyponatremia may occur during treatment with sertraline. This often develops in elderly patients, as well as when taking diuretics or a number of other drugs. A similar side effect is associated with the syndrome of inappropriate secretion of antidiuretic hormone. With the development of symptomatic hyponatremia, sertraline should be discontinued and adequate therapy aimed at correcting the level of sodium in the blood should be prescribed. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, weakness, and unsteadiness, which can lead to falls. In more severe cases, hallucinations, fainting, convulsions, coma, respiratory arrest, and death may occur.
Influence on the ability to drive vehicles and control mechanisms:

Appointment, sertraline, as a rule, is not accompanied by a violation of psychomotor functions. However, its use simultaneously with other drugs can lead to impaired attention and coordination of movements. Therefore, during treatment with sertraline, it is not recommended to drive vehicles, special equipment or engage in activities associated with an increased risk.

Form

Opaque polypropylene and aluminum foil blisters of 14 film-coated tablets of 50 and 100 mg; 1 or 2 blisters in a cardboard box along with instructions for use.

Expiration date :
5 years. Do not use after the expiry date stated on the package.

Storage conditions

List B.
At a temperature not exceeding 30 ° C, out of the reach of children.

Terms of dispensing from pharmacies

Prescription.

Manufacturer

Pfizer Inc., USA, manufactured by Haupt Pharma Latina S.r.l., Italy Legal address: S.S. 156 Km 47, 600 04100, Borgo San Michele, Latina, Italy.
Claims of consumers and complaints about the quality of the drug should be sent to the address of the representative office of Pfizer H. Si. Pi. Corporation»:
109147 Moscow, Taganskaya street, 17-23

Zoloft®, tablets, 100 mg their cancellation.

Blood levels of tricyclic antidepressants should be monitored to assess the need for dose adjustment.

With the simultaneous use of sertraline and tolbutamide, it is necessary to control the concentration of blood glucose (see section “Drug Interactions”).

Serotonin syndrome

Serotonin syndrome (SS) and neuroleptic malignant syndrome (NMS) have been reported with SSRIs. The risk of these complications increases with the simultaneous use of SSRIs with other serotonergic drugs (including amphetamines, triptans and fentanyl and their analogues, tramadol, dexomethorphan, tapentadol, meperedine, methadone, pentazocine), as well as drugs that affect the metabolism of serotonin (in including MAO inhibitors), antipsychotics and other dopamine receptor antagonists. Manifestations of SS may include changes in mental status (in particular, agitation, hallucinations, coma), autonomic lability (tachycardia, fluctuations in blood pressure, hyperthermia), changes in neuromuscular transmission (hyperreflexia, impaired coordination of movements) and / or disorders of the gastrointestinal tract (nausea, vomiting and diarrhea). Some manifestations of SS, incl. hyperthermia, muscle rigidity, autonomic lability with possible rapid fluctuations in vital signs, and changes in mental status may resemble symptoms that develop in NMS. Patients should be observed for the development of clinical manifestations of SS and NMS.

QT interval prolongation _c or torsade de pointes (TdP) ventricular tachysystolic arrhythmia

Cases of QT interval prolongation have been reported during post-marketing use of sertraline _c on the ECG and the development of ventricular tachysystolic arrhythmia pirouette type (TdP). Most of the cases were observed in patients with risk factors for the development of such conditions. Therefore, caution should be exercised when using sertraline in patients with risk factors for QT prolongation _c on the ECG or the development of ventricular tachysystolic arrhythmia of the “pirouette” type (TdP) (see the section “Drug Interactions”).

Switching from other SSRIs, antidepressants or anti-obsessional drugs

The necessary interval between stopping one SSRI and starting another similar drug has not been established. Caution should be exercised when switching to sertraline from other SSRIs, antidepressants, or anti-obsessional drugs, especially from long-acting drugs such as fluoxetine.

There is no need for a “washout period” when replacing one serotonin reuptake inhibitor with another. However, caution is required when changing the course of treatment.

Other serotonergic drugs, eg tryptophan, fenfluramine and 5HT agonists paraty, St. John’s wort) follows be carried out with caution and, if possible, avoided, given the potential pharmacodynamic interaction.

Suicidal behavior

Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide. This risk persists until a stable remission. Given that improvement in the patient’s condition may not occur in the first few weeks of therapy or longer, patients should be carefully monitored until such improvement occurs. It is also common to increase the risk of suicide in the early stages of recovery.

Other conditions for which sertraline may be prescribed may also be associated with an increased risk of suicidal events. In addition, these disorders may accompany major depressive disorder. In this regard, the same precautions should be taken as in the treatment of major depressive disorder.

Patients with a history of suicidal tendencies or patients prone to suicidal ideation before therapy have a higher risk of suicidal thoughts or suicide attempts. Such patients should also be under close medical supervision during therapy.

All patients, especially at risk, receiving sertraline therapy should be closely monitored for the development or worsening of symptoms of suicidal behavior. Patients, their relatives and caregivers should be advised to monitor for the onset or worsening of depression, the appearance of suicidal thoughts or behavior, and for any changes in behavior, especially at the beginning of therapy and with any change in the dose of the drug. The risk of suicide attempts should also be kept in mind, especially in patients with depression. In this regard, in order to reduce the risk of overdose, it is necessary to take the minimum dose of the drug that provides a sufficient therapeutic effect.

Patients with depression and other psychiatric disorders are at risk of suicidal behavior. By themselves, these diseases are strong predisposing factors for such behavior. In children, adolescents and young adults (aged 18-24 years) with depression or other psychiatric disorders, antidepressants (SSRIs and others) have been found to increase the risk of suicidal thoughts and suicidal behavior compared to placebo. Therefore, when using sertraline or any other antidepressant in children, adolescents and young adults (under 24 years of age), the risk of suicide should be weighed against the benefits of their use. In addition, there was no increase in the risk of suicidal behavior in adults older than 24 years, and in patients aged 65 years and older, there was a decrease in such risk.

Sexual dysfunction

Selective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction (see section “Side Effects”). There have been reports of prolonged sexual dysfunction, the symptoms of which persisted despite discontinuation of SSRIs.

Use in children and adolescents under 18 years of age

Sertraline should not be used in children and adolescents under 18 years of age, except in patients with OCD aged 6-17 years. Suicidal tendencies (suicide attempts or suicidal thoughts) and hostility (predominantly aggressiveness, oppositional behavior and anger) were more frequently observed in patients receiving antidepressant therapy than in patients receiving placebo. If, based on a clinical assessment of the patient, a decision was made to conduct therapy, the patient’s condition should be carefully monitored for symptoms of suicidal behavior. In addition, it should be borne in mind that data on the effect of the drug on growth, puberty and the cognitive and behavioral development of the child are limited. In long-term therapy of pediatric patients, clinicians should monitor for developmental abnormalities.

Withdrawal syndrome

Discontinuation of the drug often causes withdrawal symptoms, especially in case of abrupt withdrawal of the drug. Withdrawal symptoms were observed in 23% of patients who stopped taking sertraline and in 12% of patients who continued taking the drug. The risk of developing these symptoms depends on several factors, including the duration of therapy and dosage, as well as the rate of dose reduction. The most common reactions are dizziness, sensory disturbances (including paresthesia), sleep disturbances (including insomnia and deep sleep), agitation or anxiety, nausea and/or vomiting, tremor and headache. Usually these symptoms are mild to moderate; however, in some cases they can be severe. Usually these symptoms occur within the first few days of discontinuation of therapy, but there are very rare reports of the development of such symptoms in patients who inadvertently missed a dose. Usually these manifestations do not worsen and disappear within 2 weeks, except in some cases when they can last longer (2-3 months or more). In this regard, it is recommended to cancel the drug gradually, reducing the dose over several weeks or months, depending on the patient’s condition.

Akathisia/psychomotor agitation

The use of sertraline may be associated with the development of akathisia, characterized by a subjective sensation of discomfort or restlessness and a need to move, accompanied by an inability to sit or stand still. Most often, these symptoms are observed in the first weeks of treatment. Increasing the dose in these patients may be harmful.

Hepatic impairment

If sertraline is required in patients with hepatic impairment, consideration should be given to reducing the dose or frequency of administration. Sertraline should not be taken in patients with severe hepatic impairment.

Impaired renal function

It was found that, as expected, given the insignificant renal excretion of sertraline, dose adjustment of its dose depending on the severity of renal failure was not required.

Electroconvulsive therapy

The possible success or risk of such combined treatment has not been studied (no clinical data).

Convulsions

There is no experience with the use of sertraline in patients with convulsive syndrome, therefore its use in patients with unstable epilepsy should be avoided, and patients with controlled epilepsy should be carefully monitored during treatment. If convulsions occur, the drug should be discontinued.

Activation of mania/hypomania

During clinical studies prior to the introduction of sertraline to the market, hypomania and mania were observed in approximately 0.4% of patients treated with sertraline. Cases of activation of mania/hypomania are also described in a small proportion of patients with manic-depressive psychosis treated with other antidepressant or anti-obsessional drugs. Sertraline should be used with caution in patients with a history of mania or hypomania. Careful supervision of a physician is necessary and sertraline should be discontinued if the patient shows any signs of a manic state.

Schizophrenia

Patients with schizophrenia may experience exacerbation of psychotic symptoms.

Pathological bleeding/bleeding

There have been reports of bleeding or bleeding (from ecchymosis and purpura to life-threatening bleeding/bleeding) during the use of SSRIs. Caution should be exercised when prescribing SSRIs in combination with drugs that have an established ability to influence platelet function (for example, atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and nonsteroidal anti-inflammatory drugs), as well as in patients with a history of hemorrhagic diseases.

In addition, when using sertraline with indirect anticoagulants, it is recommended to control prothrombin time at the beginning of sertraline treatment and after its withdrawal.

Hyponatremia

Transient hyponatremia occurs more often in older patients, in patients with dehydration or when taking diuretics. This side effect is associated with the syndrome of inappropriate ADH secretion. Cases of a decrease in the concentration of sodium in the blood plasma below 110 mmol / l have been reported. With the development of symptomatic hyponatremia, sertraline should be discontinued and adequate therapy aimed at correcting the concentration of sodium in the blood should be prescribed. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, weakness, and unsteadiness, which can lead to falls. In more severe cases, hallucinations, fainting, convulsions, coma, respiratory arrest and death may occur.

Because there is a clear relationship between depression and OCD, depression and panic disorder, depression and PTSD, depression and social phobia, the same precautions should be taken when treating patients with OCD, panic disorder, PTSD and social phobia as and in the treatment of depression.

Fractures

Epidemiological studies have shown that the use of serotonin reuptake inhibitors, including sertraline, increases the risk of fractures. The mechanism leading to increased risk is not fully understood.

Elderly patients

The profile of adverse reactions in elderly and young patients does not differ. In the elderly, the drug should be used with caution due to the increased risk of hyponatremia.

Diabetes mellitus/impaired blood glucose control

When using SSRIs, incl. Zoloft ^® , there have been cases of exacerbation of diabetes mellitus and / or impaired glucose control (hyperglycemia and hypoglycemia) in patients with or without diabetes mellitus. In this regard, it is necessary to control the level of glucose. Particular attention is required for patients with diabetes mellitus, because. they may require dose adjustment of oral hypoglycemic agents and/or insulin.

Angle-closure glaucoma

SSRIs, including sertraline, affect pupil size resulting in mydriasis. At the same time, there is a narrowing of the angle of the eye, which leads to an increase in intraocular pressure and the development of angle-closure glaucoma, especially in patients with a predisposition. The drug should be used with caution in patients with angle-closure glaucoma or a history of glaucoma.

Laboratory methods

False-positive urinary immunoassays for benzodiazepines have been reported in patients treated with sertraline. This is due to the low specificity of screening tests. Also, false-positive results may occur within a few days after discontinuation of sertraline therapy. Additional tests such as gas chromatography and mass spectrometry can help distinguish sertraline from benzodiazepines.

Grapefruit juice

Concomitant use of sertraline and grapefruit juice is not recommended.

Influence on the ability to drive vehicles and mechanisms

The use of sertraline, as a rule, is not accompanied by a violation of psychomotor functions. However, its use simultaneously with other drugs can lead to impaired attention and coordination of movements. Therefore, during treatment with sertraline, it is not recommended to drive vehicles, special equipment or engage in activities associated with an increased risk.