How does hydroxyzine work for anxiety. What is the recommended dosage of hydroxyzine for anxiety. What are the potential side effects of using hydroxyzine for anxiety. How does hydroxyzine compare to other anxiety medications. Is hydroxyzine an effective treatment option for anxiety disorders.

Understanding Hydroxyzine: An Antihistamine for Anxiety Treatment

Hydroxyzine is a prescription antihistamine that has gained recognition for its effectiveness in treating anxiety disorders. While many people associate anxiety treatment with selective serotonin reuptake inhibitors (SSRIs) or benzodiazepines, hydroxyzine offers an alternative approach. This medication, available in both generic and branded forms (Vistaril), works by influencing histamine and serotonin levels in the brain.

What is hydroxyzine?

Hydroxyzine is an antihistamine primarily used to treat anxiety, but it also has applications in managing allergies, difficulty sleeping, itching, nausea, skin rashes, and vomiting. Unlike over-the-counter antihistamines, hydroxyzine requires a prescription due to its potent effects and potential for treating anxiety disorders.

Forms of hydroxyzine

Hydroxyzine is available in two main forms:

• Hydroxyzine hydrochloride (HCL): Available as generic tablets (10mg, 25mg, 50mg) and liquid (10mg/5ml)
• Hydroxyzine pamoate (pam): Available as generic and branded (Vistaril) capsules (25mg, 50mg) and liquid (25mg/5ml)

The Mechanism of Action: How Hydroxyzine Works for Anxiety

Hydroxyzine’s effectiveness in treating anxiety stems from its dual action as an antihistamine and serotonin antagonist. By understanding its mechanism of action, we can better appreciate how this medication helps alleviate anxiety symptoms.

Antihistamine properties

As an antihistamine, hydroxyzine reduces the effects of histamine in the body. Histamine is a chemical involved in allergic reactions and also plays a role in regulating arousal and anxiety levels. By blocking histamine receptors, hydroxyzine can help reduce anxiety-related symptoms.

Serotonin modulation

Hydroxyzine acts as a serotonin antagonist, meaning it blocks the reabsorption of serotonin in the brain. This action is similar to that of SSRIs, resulting in increased serotonin levels. Serotonin is a neurotransmitter crucial for mood regulation, feelings of contentment, and overall well-being.

Dosage Guidelines: Finding the Right Amount of Hydroxyzine for Anxiety

Determining the optimal dosage of hydroxyzine for anxiety treatment is crucial for achieving the best results while minimizing potential side effects. Healthcare providers typically tailor the dosage to individual needs and responses.

Standard dosage for adults

For adults, the typical dosage of hydroxyzine for anxiety ranges from 50 to 100 mg, taken four times a day. However, some individuals may require higher doses to achieve symptom relief. It’s important to follow your healthcare provider’s instructions carefully.

Dosage for children

Children under 6 years old should not exceed 50 mg per day, divided into smaller doses. As with all medications, pediatric dosing should be carefully monitored and adjusted by a healthcare professional.

Flexible dosing options

Hydroxyzine can be taken on a regular schedule or as needed for anxiety symptoms. Your healthcare provider will advise you on the best approach based on your specific situation. If you experience stomach upset, taking hydroxyzine with food may help alleviate this side effect.

Potential Side Effects and Precautions When Using Hydroxyzine for Anxiety

While hydroxyzine can be an effective treatment for anxiety, it’s important to be aware of potential side effects and take necessary precautions. Understanding these factors can help you make an informed decision about using hydroxyzine as part of your anxiety management plan.

Common side effects

Some of the more frequently reported side effects of hydroxyzine include:

• Drowsiness or sedation
• Dry mouth
• Dizziness
• Constipation
• Blurred vision
• Headache

Precautions and contraindications

Certain individuals should exercise caution or avoid using hydroxyzine altogether:

1. Pregnant or breastfeeding women should consult their healthcare provider before using hydroxyzine.
2. People with a history of long QT syndrome or other heart rhythm disorders should avoid hydroxyzine due to potential cardiac effects.
3. Individuals with liver or kidney problems may require dosage adjustments.
4. Those taking other medications that cause drowsiness should be cautious when using hydroxyzine.

Comparing Hydroxyzine to Other Anxiety Medications

When considering treatment options for anxiety, it’s helpful to understand how hydroxyzine compares to other commonly prescribed medications. This comparison can aid in discussions with your healthcare provider about the most suitable treatment approach for your specific needs.

Hydroxyzine vs. SSRIs

While both hydroxyzine and SSRIs influence serotonin levels, they differ in several aspects:

• Onset of action: Hydroxyzine typically provides more immediate relief, while SSRIs may take several weeks to reach full effectiveness.
• Duration of treatment: Hydroxyzine can be used on an as-needed basis, whereas SSRIs are generally prescribed for long-term, daily use.
• Side effect profile: Hydroxyzine may cause more sedation, while SSRIs can have different side effects such as sexual dysfunction or weight changes.

Hydroxyzine vs. Benzodiazepines

Comparing hydroxyzine to benzodiazepines reveals some key differences:

• Mechanism of action: Hydroxyzine works on histamine and serotonin systems, while benzodiazepines enhance GABA activity in the brain.
• Addiction potential: Hydroxyzine has a lower risk of dependence compared to benzodiazepines.
• Duration of effects: Hydroxyzine’s effects may last longer than some short-acting benzodiazepines.

The Onset and Duration of Hydroxyzine’s Effects on Anxiety

Understanding how quickly hydroxyzine works and how long its effects last can help you manage your anxiety symptoms more effectively. This knowledge is crucial for both patients and healthcare providers in developing an optimal treatment plan.

Time to onset

Hydroxyzine typically begins to take effect within 15 to 30 minutes after ingestion. This relatively rapid onset of action makes it suitable for managing acute anxiety symptoms or panic attacks. However, individual responses may vary, and some people might experience relief sooner or later than this average timeframe.

Duration of effects

The anxiolytic effects of hydroxyzine generally last for 4 to 6 hours. This duration allows for flexible dosing throughout the day, depending on individual needs and the severity of anxiety symptoms. Some people may find that the effects last longer, particularly if they are more sensitive to the medication.

Factors influencing effectiveness

Several factors can impact how quickly hydroxyzine works and how long its effects last:

• Individual metabolism
• Dosage
• Frequency of use
• Concurrent medications
• Severity of anxiety symptoms

Hydroxyzine for Sleep: A Dual-Purpose Medication

In addition to its anxiolytic properties, hydroxyzine is often prescribed to help with sleep issues. This dual functionality can be particularly beneficial for individuals who experience both anxiety and insomnia, as these conditions frequently co-occur.

Mechanism for sleep improvement

Hydroxyzine’s sedative effects stem from its antihistamine properties. By blocking histamine receptors in the brain, it can promote drowsiness and help initiate sleep. Additionally, by reducing anxiety, hydroxyzine may indirectly improve sleep quality by allowing individuals to relax more easily at bedtime.

Dosage for sleep

When prescribed for sleep, hydroxyzine dosages may differ from those used primarily for anxiety:

• Typical dosage range: 25 to 100 mg taken at bedtime
• Onset: Effects usually begin within 30 minutes to an hour after ingestion
• Duration: Sleep-promoting effects can last for 6 to 8 hours

Considerations for long-term use

While hydroxyzine can be effective for short-term sleep issues, it’s important to address underlying causes of insomnia for long-term management. Cognitive behavioral therapy for insomnia (CBT-I) and good sleep hygiene practices should be considered alongside medication use.

Integrating Hydroxyzine into a Comprehensive Anxiety Treatment Plan

While hydroxyzine can be an effective tool for managing anxiety, it’s most beneficial when incorporated into a comprehensive treatment approach. Combining medication with other therapeutic strategies can lead to better outcomes and improved quality of life for those struggling with anxiety disorders.

Psychotherapy

Cognitive-behavioral therapy (CBT) is often considered the gold standard for anxiety treatment. Combining hydroxyzine with CBT can provide both immediate symptom relief and long-term coping strategies. Other forms of therapy, such as exposure therapy or mindfulness-based approaches, may also be beneficial when used in conjunction with medication.

Lifestyle modifications

Implementing healthy lifestyle changes can significantly enhance the effectiveness of hydroxyzine and overall anxiety management:

• Regular exercise
• Balanced diet
• Stress reduction techniques (e.g., meditation, deep breathing exercises)
• Adequate sleep
• Limiting caffeine and alcohol intake

Monitoring and adjustment

Regular check-ins with your healthcare provider are crucial when using hydroxyzine for anxiety. This allows for:

• Dosage adjustments based on symptom response
• Assessment of side effects
• Evaluation of overall treatment effectiveness
• Consideration of alternative or additional treatments if needed

By taking a holistic approach to anxiety management, individuals can maximize the benefits of hydroxyzine while developing a well-rounded set of tools to cope with anxiety in the long term.

Hydroxyzine for Anxiety — How It Works

When asked to think of medications commonly used to treat anxiety, chances are high that selective serotonin reuptake inhibitors (SSRIs)—such as Lexapro and Zoloft—or benzodiazepines—like Ativan, Xanax, and Klonopin —frequently come to mind. But these are not the only kinds of medications that can effectively treat anxiety. Another option to consider is hydroxyzine, a prescription antihistamine that is approved to treat anxiety. (Hydroxyzine for sleep is also a common treatment.)

This Minded Medication Guide will take a closer look at hydroxyzine for anxiety to help you when talking with your doctor, prescribing nurse, or Minded provider to choose the right medication for your treatment plan.

Read on to learn more about this medication, including:

• What is hydroxyzine?
• How does hydroxyzine work for anxiety?
• What is the best dose of hydroxyzine for anxiety?
• What are some of the possible side effects of hydroxyzine?
• What cautions should you be aware of before, during, and after using hydroxyzine for anxiety?
• How long does it take for hydroxyzine to work for anxiety?
• How does hydroxyzine compare to other types of anxiety medications?

Minded Medication Guides, including Zoloft vs Prozac and Wellbutrin vs Lexapro, are intended as educational aids only. They are not intended as medical advice for individual conditions or treatment. They are not a substitute for a medical exam, nor do they replace the need for services provided by medical professionals. Talk to your doctor, nurse, or pharmacist before taking any prescription medication or following any treatment or regimen.

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Hydroxyzine is an antihistamine used to treat anxiety. It is also sometimes used to treat:

• Allergies
• Difficulty sleeping
• Itching
• Nausea
• Skin rash
• Vomiting

As with all antihistamines, hydroxyzine works by reducing the effects of histamine (a chemical in your body that produces an allergic reaction).

However, while many antihistamines are available over-the-counter (without a prescription), hydroxyzine is a prescription medication. You may see it listed as hydroxyzine hydrochloride (hydroxyzine HCL) or hydroxyzine pamoate (hydroxyzine pam). It may also be listed under the brand name Vistaril.

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How does hydroxyzine for anxiety work?

While hydroxyzine is an antihistamine, it is also a serotonin antagonist. In other words, taking hydroxyzine or Vistaril for anxiety works similarly to taking SSRIs—another type of medication used to treat anxiety—by making more serotonin available in your brain. As a serotonin antagonist, hydroxyzine boosts the levels of serotonin in your brain by blocking it from being reabsorbed into the nerves in your brain (called neurons). Serotonin is a neurotransmitter that plays a role in keeping your mood balanced. It also affects feelings of contentment, optimism, and satisfaction, and your overall sense of well-being.

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When taking hydroxyzine for anxiety, it can be prescribed in capsule, tablet, and liquid forms. As mentioned above, this medication is available as hydroxyzine hydrochloride (hydroxyzine HCL) or hydroxyzine pamoate (hydroxyzine pam). While hydroxyzine pamoate is available in both generic and branded forms (branded as Vistaril), hydroxyzine hydrochloride is only available as a generic. (The branded version of hydroxyzine HCL, called Atarax, was discontinued.)

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Hydroxyzine pamoate for anxiety

Hydroxyzine pamoate (Vistaril):

Capsules

• 25 mg
• 50 mg

Liquid

• 25 mg/5 ml

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Hydroxyzine HCL for anxiety

Hydroxyzine hydrochloride (HCL)

Tablets

• 10 mg
• 25 mg
• 50 mg

Liquid

• 10 mg/5 ml

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Best dose of hydroxyzine for anxiety

When prescribing hydroxyzine for anxiety, doctors and nurse practitioners typically recommend taking it in multiple doses throughout the day. For adults, 50 to 100 mg (taken 4 times a day) is typical, though some people may need higher doses to achieve symptom relief. For children under the age of 6 years old, no more than 50 mg per day (divided into small doses) is recommended.

Hydroxyzine can be taken daily (with or without food) at regularly scheduled times or on an as-needed basis. If you have an upset stomach after taking hydroxyzine, you may want to take it with food. Your doctor or prescribing nurse will provide you with instructions on how often and when to take this medication, as well as the maximum amount to take in a day.

If you miss a dose of hydroxyzine, either take the missed dose as soon as you remember—or, if it is closer to the time when you would take your next dose, just take the next dose.

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Which is better for anxiety: hydroxyzine HCL vs hydroxyzine pam?

Both hydroxyzine hydrochloride (HCL) and hydroxyzine pamoate (pam) can be prescribed to treat anxiety. The main difference between the two is the form that each is available in—hydroxyzine HCL is available in tablets and liquid, while hydroxyzine pam is available in capsules and liquid.

You may prefer one form of medication over the other (tablets vs capsules), or you may find that one or the other works better for you personally. Your doctor, prescribing nurse, or Minded professional can work with you to determine which form of this medication is best for your anxiety treatment plan.

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Hydroxyzine side effects

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Common side effects of hydroxyzine include:

• Blurred vision
• Confusion
• Dizziness
• Drowsiness
• Dry mouth
• Fatigue
• Headache
• Irritability
• Urinary retention (when your bladder does not empty all the way)

Talk to your doctor or the experts at Minded if you experience any of these or other side effects.

Rare or serious side effects of hydroxyzine include:

• Allergic reaction to the medication, even though the medication generally is taken to reduce allergic reactions (symptoms of this could include: difficulty breathing; hives; and swelling in your lips, tongue, or face)
• Confusion
• Hallucinations
• Increased heart rate and/or abnormal heartbeat
• Priapism (an erection lasting longer than 4 hours)
• Skin rash (called acute generalized exanthematous pustulosis, or AGEP)

Seek medical attention right away if you experience any of these (or other) serious side effects.

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Hydroxyzine warnings

Drinking alcohol is not recommended while taking hydroxyzine. Alcohol can decrease the benefits of medications like hydroxyzine and increase their side effects (such as sedation). Alcohol also can impair memory and judgment, accidentally resulting in taking a higher dose of hydroxyzine than prescribed, which could induce an accidental overdose.

Symptoms of a hydroxyzine overdose include:

• Coma
• Confusion
• Decreased coordination
• Difficulty urinating
• Drowsiness
• Dry mouth
• Headache
• Rapid heartbeat
• Slowed reflexes
• Seizures

Always discuss your anxiety treatment plan with your doctor if you are pregnant or planning on becoming pregnant. Hydroxyzine should typically not be taken during the first trimester of pregnancy. While you may take it during the second and third trimesters, it should not be taken right before or during labor.

Because hydroxyzine can be passed to your baby through breast milk, taking it while breastfeeding is not recommended.

Tell your doctor or a Minded professional about any other medications or supplements you may be taking to determine if hydroxyzine might have any negative interactions with them.

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When taking hydroxyzine or Vistaril for anxiety, how long does it take to work?

If you’re taking hydroxyzine for anxiety, you will find that it is relatively fast-acting compared to some other medications, like SSRIs. While you may have to take SSRIs for a few weeks before you start to see improvement in your anxiety symptoms, with hydroxyzine, you may notice your symptoms begin to improve quickly, often within hours of first taking it.

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How long does hydroxyzine last for anxiety?

The effects of hydroxyzine typically last 3 to 4 hours.

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SSRIs vs hydroxyzine for anxiety

While you can take selective serotonin reuptake inhibitors (SSRIs) or hydroxyzine for anxiety, there are some key differences to keep in mind.

• How quickly your anxiety symptoms begin to decrease: While you may notice that your anxiety symptoms begin to decrease hours after first taking hydroxyzine, the benefits of SSRIs may not begin to become apparent until a few weeks after you start taking them.
• How often you take the medications: Hydroxyzine is typically taken in multiple doses throughout the day. SSRIs usually are taken once daily.
• Common side effects: Both hydroxyzine and SSRIs come with a risk of side effects, but the side effects for each are different.
• Common side effects of hydroxyzine include: blurred vision, confusion, dizziness, dry mouth, fatigue, headache, irritability, urinary retention‍
• Common side effects of SSRIs include: dizziness, drowsiness, dry mouth, headache, insomnia, nervousness, sexual problems, stomach upset, weight gain, and/or weight loss‍
• Whether they can be taken during pregnancy and/or while breastfeeding: Hydroxyzine can be taken during the second and third trimesters, but not during the first trimester or right before or during labor. SSRIs may be taken during pregnancy, with the approval of an OB-GYN doctor. Neither hydroxyzine nor SSRIs should be taken while breastfeeding without first talking to your OB-GYN doctor or pediatrician.

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Benzodiazepines vs hydroxyzine for anxiety

Benzodiazepines—such as Xanax and Ativan and Klonopin—are another type of medication that can be used to treat anxiety. Like hydroxyzine, these medications are relatively fast-acting—your symptoms may begin to decrease within hours of taking your first dose. Also, like taking hydroxyzine for anxiety, benzodiazepines are typically taken in multiple doses throughout the day. There are, however, several important differences between hydroxyzine and benzodiazepines to consider.

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• Common side effects: Both hydroxyzine and benzodiazepines come with a risk of side effects, but the side effects for each are different.‍
• Common side effects of hydroxyzine include: blurred vision, confusion, dizziness, dry mouth, fatigue, headache, irritability, urinary retention‍
• Common side effects of benzodiazepines include: decreased coordination, difficulty concentrating, dizziness, drowsiness, fatigue, lightheadedness 
• Whether they can be taken during pregnancy and/or while breastfeeding: Hydroxyzine can be taken during the second and third trimesters, but not during the first trimester or right before or during labor. Benzodiazepines typically should not be taken during pregnancy. Neither hydroxyzine nor benzodiazepines should be taken while breastfeeding without talking to your OB-GYN doctor or pediatrician.
• How long they are usually used for: While hydroxyzine may be taken long-term, benzodiazepines are typically prescribed for short-term use (weeks or months).

Another thing to keep in mind is that even though the Drug Enforcement Administration has classified benzodiazepines as controlled substances, they are considered safe for most people who take them for anxiety. The risk of dependence or abuse is higher in people with a history of a substance use disorder as well as those who take more than the prescribed dose of the medication.

On the other hand, hydroxyzine is not a controlled substance and does not carry the same risk of dependency or abuse.

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Hydroxyzine vs Benadryl for anxiety

While hydroxyzine and Benadryl (the brand name for diphenhydramine) are both antihistamines, this does not mean they can both be used to treat anxiety. Benadryl, which is available over-the-counter (meaning it does not require a prescription) is not approved to treat anxiety—it is approved to treat hay fever, allergies, and cold symptoms. In fact, increased anxiety, agitation, and nervousness are potential side effects of Benadryl.

Additionally, while hydroxyzine is considered safe for long-term use, Benadryl may increase your risk of developing dementia if used long-term, according to a 2015 study published in CMAJ. A 2017 study published in Neurology Clinical Practice also found that there is a risk of becoming dependent on or misusing Benadryl. However, as with benzodiazepines, this risk may be higher in people who have a history of addiction.

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If you are looking for a fast-acting medication that can be taken long-term for anxiety treatment, it may be worth discussing hydroxyzine with your doctor, prescribing nurse, or a Minded professional. 

When comparing hydroxyzine to other common types of anxiety medications, it is important to remember that each type of medication has its own pros and cons. And while there are some similarities between the different kinds of medications, there are also some key differences. For example:

• Whether it is safe for long-term use: Like SSRIs (and generally unlike benzodiazepines), hydroxyzine can be taken long-term. 
• The number of doses taken per day: Like benzodiazepines (and unlike SSRIs), hydroxyzine is taken in multiple doses throughout the day rather than once daily.
• How quickly symptom relief may begin: Hydroxyzine is fast-acting (like benzodiazepines), with symptoms typically starting to improve within a few hours of the first dose (compared to a few weeks for SSRIs).
• Whether it is safe to drink alcohol while taking this medication: Drinking alcohol is not recommended while on hydroxyzine (the same is true of SSRIs and benzodiazepines).
• Whether this medication can be taken during pregnancy or while breastfeeding: Hydroxyzine can be taken during the second and third trimesters of pregnancy (except right before and during labor). SSRIs and benzodiazepines typically should not be taken during pregnancy. None of these medications should be taken while breastfeeding.

To find out if hydroxyzine could work for your anxiety treatment, visit Minded and get a free assessment. Minded offers online appointments with board-certified psychiatrists and nurse practitioners. If you already have a hydroxyzine prescription, Minded can help you refill or renew it online. Our team of professionals can also assist with adjusting your dosage or advising you about other medications that might be a good fit for your needs.

Can you take hydroxyzine for anxiety and sleep?

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Feb 13, 2023.

Hydroxyzine is a sedating antihistamine that can be used short-term to treat anxiety and trouble sleeping, but is not meant for long-term use. Medicines typically used first-line for the treatment of anxiety are the antidepressants like the SSRIs or SNRIs (for example: paroxetine, sertraline, escitalopram).

Hydroxyzine can provide relief from generalized anxiety disorder (GAD) and insomnia until your other treatment starts to work. In many people, sleep will improve once the anxiety lessens and symptoms improve.

What are the FDA approved uses for hydroxyzine?

Hydroxyzine is a prescription antihistamine classified as an histamine h2 antagonist with sedating properties. It is similar to diphenhydramine (Benadryl), a common over-the-counter antihistamine. It is used:

• to treat anxiety (generalized anxiety disorder or GAD)
• to treat chronic itching due to allergies (hives, contact dermatitis)
• to help with sleep (as a sedative) before surgery

In some cases, it may also be used as an antiemetic to treat an upset stomach or vomiting, but it is not specifically approved by the FDA for this use.

Hydroxyzine comes as two different formulations: hydroxyzine hydrochloride (Atarax) and hydroxyzine pamoate (Vistaril). The brand name product Atarax is no longer marketed but you can get hydroxyzine hydrochloride as a generic medicine.

How does hydroxyzine work for anxiety?

Researchers are not exactly sure how hydroxyzine works for anxiety, but it does increase serotonin levels in your brain in addition to blocking histamine activity in the body. Serotonin is a neurotransmitter that plays a part in keeping your mood balanced, and the antihistamine effect causes drowsiness.

• Hydroxyzine has activity at the serotonergic (5HT2) receptors in the brain which may contribute to its anti-anxiety effect.
• Antihistamines which work at the h2 receptor, like hydroxyzine, can cause drowsiness, which may be helpful if you experience insomnia with your anxiety.

How quickly does it work?

Hydroxyzine starts to work quickly, usually within the first 15 to 30 minutes after you take a dose.

• Side effects like drowsiness, dry eyes, blurred vision, or a dry mouth, may occur quickly too. Sometimes, people can feel nauseous or have stomach upset when they take this medicine. Take the medicine with food to see if that helps.
• Do not drive or operate dangerous machinery until you know how this drug affects you. Avoid drinking alcohol and taking other medicines that may also make you drowsy.
• Over time, these side effects usually subside as you get used to the medicine.

How much should you take?

The usual starting oral dose of hydroxyzine for anxiety in adults is 25 to 50 mg up to four times daily as needed. For insomnia associated with anxiety, 50 milligrams (mg) at bedtime may be used. Your doctor may adjust your dose based on effectiveness or side effects.

The maximum single dose is 100 mg and the maximum dose per day is 400 mg. Lower doses or an alternative treatment may be need in older adults due to side effects.

• You can take this medicine with or without food, but if it upsets your stomach, it may help to take it with food.
• When taken to help with insomnia (trouble sleeping) due to anxiety, doses are taken at bedtime due to the drowsy effect.
• Follow your doctor’s dosing instructions exactly. High doses or an overdose of this medicine can be dangerous. If an overdose occurs, contact emergency medical help right away.

Be sure to tell your doctor and pharmacist about the medicines you use, including prescription, over-the-counter (OTC) or herbal and dietary supplements. Some common medicines have drug interactions with hydroxyzine and you may need a dose adjustment.

Related: Hydroxyzine drug interactions (in more detail)

Is hydroxyzine safe for older patients?

Use of this drug is often not recommended in patients over 65 years of age due to potent anticholinergic side effects like confusion, dry mouth, urinary retention and constipation. It can also lead to extreme drowsiness which may increase the risk for a fall.

Some research also suggests a link between prolonged use of medicines with anticholinergic properties, such as hydroxyzine, and the occurrence of dementia, particularly in older adults.

Certain guidelines (for example: Beers Criteria, Pharmacy Quality Alliance) consider hydroxyzine a high-risk drug in older patients. Elderly patients may need alternative treatments to safely treat anxiety or insomnia.

Learn more: Anticholinergic Drugs to Avoid in the Elderly

Can you take hydroxyzine daily? How long can you safely take it?

Hydroxyzine is not usually meant to be a long-term daily solution for anxiety or sleep for most people. Hydroxyzine may not work as well if you take it daily. You can build a tolerance to the medicine over time, which means your body gets used to the medicine and the effect lessens.

The manufacturer states that the effectiveness of hydroxyzine in treating anxiety for longer than 4 months has not been evaluated in studies; however, your doctor will monitor your response and can determine the appropriate length for treatment.

Hydroxyzine is not a controlled substance and is not physically habit-forming like Xanax (alprazolam), a benzodiazepine that is used to treat anxiety.

If you find your medicine is not working well for you, contact your doctor. You may need a dose adjustment or a different treatment. Do not adjust doses on your own.

Is hydroxyzine expensive?

No, generic hydroxyzine is usually very affordable. It is available as an oral tablet, capsule, oral syrup and as an injection.

All forms are available generically and 30 tablets usually costs less than $20 at the pharmacy. Injections may be more expensive, especially if they are given at your doctor’s office or a hospital.

Prices can vary based on location, pharmacy, insurance and any discount coupons you may be using.

Bottom Line

• Hydroxyzine can be helpful for insomnia related to anxiety in the short-term, but is not meant for long-term use. Serotonin medicines are usually the initial long-term treatments used for anxiety.
• If you are experiencing anxiety or trouble sleeping, speak with your doctor about available treatments. Do not adjust medicines or doses on your own.
• Hydroxyzine can be associated with side effects like extreme drowsiness, dry mouth, confusion, urinary retention, and constipation, especially in the elderly. Some guidelines consider hydroxyzine a high-risk medicine in people over the age of 65 due to these anticholinergic side effects.

This is not all the information you need to know about hydroxyzine for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.

References

• Hydroxyzine hydrochloride. Teva Pharmaceutocals. Drugs @FDA. Accessed Feb 13, 2023 at  https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/088617Orig1s043,088618Orig1s043,088619Orig1s044lbl.pdf
• Vistaril prescribing information. Pfizer. Accessed Feb. 13, 2023 at https://www.pfizermedicalinformation.com/en-us/vistaril/dosage-admin
• Lader M, Scotto J. A multicentre double-blind comparison of hydroxyzine, buspirone and placebo in patients with generalized anxiety disorder. Psychopharmacology (Berl) 1998;139:402–406.
• Katzman MA, Bleau P, Blier P, et al. Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders. BMC Psychiatry. 2014;14(suppl 1):s1. doi:10.1186/1471-244X-14-S1-S1

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Medical Disclaimer

Atarax in Anxiety Disorders (Review) | Ryabokon I.

V.

Anxiety is a state of fear, anxiety experienced by a person in the conditions of expectation of trouble. The causes of anxiety are varied: emotional instability, a sharp change in living conditions, the upcoming performance of a difficult task, etc. Anxiety can arise on the basis of a premonition of a future threat (punishment or loss of loved ones). Usually, anxiety leads to defensive reactions. Anxiety is the result of frustration or its expectation and is the primary psychological manifestation of stress. Z. Freud considered anxiety as a symptomatic manifestation of an internal emotional conflict caused by the fact that a person unconsciously suppresses sensations, feelings or impulses that are too threatening or annoying for him. With the onset of anxiety, there is an increase in behavioral activity, a change in the very nature of behavior, and additional physiological mechanisms of adaptation to changed conditions are activated.

Anxiety is a person’s tendency to experience a state of anxiety. Most often, a person’s anxiety is associated with the expectation of the social consequences of his success or failure. Anxiety and anxiety are closely related to stress. On the one hand, anxious emotions are symptoms of stress. On the other hand, the initial level of anxiety determines individual sensitivity to stress. Like stress in general, anxiety is not necessarily good or bad.
Sometimes anxiety is natural, appropriate, useful. Everyone feels anxious, restless or tense in certain situations, especially if they have to do something out of the ordinary or prepare for it. For example, speaking in front of an audience with a speech or taking an exam. A person may experience anxiety when walking down an unlit street at night or when they get lost in a strange city. This kind of anxiety is normal and even beneficial, as it prompts you to prepare a speech, to study the material before the exam, to think about whether you really need to go out at night all alone.
In other cases, anxiety is unnatural, pathological, inadequate, harmful. It becomes chronic, permanent and begins to appear not only in stressful situations, but also for no apparent reason. Then anxiety not only does not help a person, but, on the contrary, begins to interfere with his daily activities.
The line between a “normal” stress response and a pathological anxiety disorder is often very blurred, making it difficult for a person to know when to seek professional help. These subsyndromic anxiety disorders are the most difficult to diagnose, often remain untreated, while having an extremely negative impact on the quality of life of the patient and those around him. It is believed that treatment options should be considered when anxiety about mundane events is beyond the patient’s control. Also, the following disorders may be the reason for prescribing therapy: nervousness, fussiness, impaired concentration, irritability, sleep disturbance, symptoms of autonomic dysfunction.
In everyday medical practice, various herbal medicines, tranquilizers, barbiturates, antidepressants, and some antipsychotics are used to treat anxiety disorders.
One of the most powerful and quickly stopping sleep disorders and anxiety are benzodiazepine drugs. Among the disadvantages of treatment with benzodiazepines, one should name: withdrawal syndrome (rapid resumption or transient increase in symptoms after discontinuation of the drug), the risk of addiction and the formation of drug dependence, impaired cognitive functions (attention, concentration, memory), impaired coordination. Therefore, drugs of the benzodiazepine group are not recommended for more than 2 weeks.
Hydroxyzine (Atarax) does not belong to either the benzodiazepine group or the phenothiazine family. The non-benzodiazepine anxiolytic Atarax (hydroxyzine) is a derivative of diphenylmethane (Diphenylmetane), a histamine h2 receptor antagonist.
Hydroxyzine, one of the oldest psychotropic drugs, was introduced into clinical practice as early as 1955. Atarax has a pronounced anti-anxiety, antihistamine, antipruritic and antiemetic effect. By reducing the concentration of histamine at the central level, it has the ability to reduce anxiety, reduce aggressiveness and cause a persistent anxiolytic effect [2]. The drug acts already 15–30 minutes after ingestion (Cmax is observed 2 hours after taking the drug) and retains this effect for 6–8 hours. Its main advantages are the absence of the “rebound” phenomenon, addiction (dependence), withdrawal symptoms and positive effect on cognitive function.
Hydroxyzine has been successfully used in various fields of medicine: as a means of controlling tobacco smoking [3]; in pediatric dentistry [4]; for its intended purpose – for the treatment of anxiety neurosis (even in the era of the existence of such a nosological form) and for “mild” depression [5]; in violations of behavior and learning in children [6]. Due to its antihistamine properties, hydroxyzine has been used in allergology, for the treatment of itching [7], in urticaria pigmentosa (mastocytosis) in children [8]; in oncology [9]; in burn patients [10], in narcology [11], and in many other conditions.
Recently, there has been interest from researchers in the use of hydroxyzine in patients with generalized anxiety disorder (GAD). The prevalence of this pathology and the associated burden of social consequences in the modern scientific literature look very significant. According to one review [E.G. Starostina. Generalized anxiety disorder and symptoms of anxiety in general medical practice. Rus. honey. magazine 2004; 22 (222), 12: 1277] with reference to numerous foreign works, “GAD is among the top ten diseases with the greatest temporary disability and, according to this indicator, is on the same level with coronary artery disease, diabetes, joint diseases, peptic ulcer, and from mental disorders – with depression or even ahead of it.”
In a double-blind, placebo-controlled RCT for the treatment of GAD [17], the anxiolytic activity of Atarax at a dose of 50 mg (in 3 doses of 12.5 mg in the morning and afternoon plus 25 mg in the evening) was shown, which manifested itself in a statistically significant, rapid and significant decrease in symptoms of anxiety already at the end of the 1st week of treatment, which persisted for another 1 week after discontinuation of treatment (n=110; course duration 4 weeks; assessment on the Hamilton-A scale). At the same time, the phenomenon of “rebound” or return of anxiety was not observed.
In another double-blind multicenter RCT [18], in which, along with placebo control, the benzodiazepine drug bromazepam was also used, it was shown that hydroxyzine used for 3 months was statistically significantly different from placebo and as effective as the comparator drug. At the same time, against the background of benzodiazepine, twice as often as with the use of hydroxyzine, adverse severe drowsiness was observed (n = 334; dose of hydroxyzine 50 mg / day in 3 doses; bromazepam – 6 mg / day in 3 doses; improvement on the Hamilton-A scale >50 %; p<0.03 at the end of the 6th week and p<0.001 - after 12 weeks; the number of patients responding to treatment: 40% at the 6th and 60% at the 12th week, respectively).
Another study [19] showed the efficacy of Atarax (50 mg in 3 divided doses) comparable to that of the control buspirone (20 mg in 3 divided doses), with a statistically significant difference between Atarax and placebo on the 28th day of treatment (p<0. 015) . There was no “rebound” phenomenon with abrupt withdrawal of both drugs (n=244; age 18–65 years).
In addition, one of the advantages of hydroxyzine is that, unlike benzodiazepines, it does not depress cognitive abilities [20] (triple crossover, double-blind RCT; comparison of a single dose of 50 mg of hydroxyzine with a single dose of 2 mg of lorazepam and placebo; n = 9; healthy volunteers; 3-day interval before crossing; assessment of cognitive functions after 2–5 hours after taking comparators).
Some studies have shown a positive effect of hydroxyzine on cognitive function [21] (comparison with lorazepam; double-blind multicenter RCT; n=30; GAD, Atarax 100 mg in 3 doses, lorazepam 4 mg in 3 doses; Beck score at 28– day of treatment). Unlike lorazepam, with the same anxiolytic activity, hydroxyzine restored cognitive function to normal limits.
Similar results were obtained in another, less evidence-based study, an open RCT (A.E. Bobrov et al. Journal of Neurology and Psychiatry named after S. S. Korsakov. 1988; 2. GAD; n=50; outpatients; treatment course of 4 weeks, plus 2 weeks of follow-up).
Given the characteristics of the drug (rapid onset of action, good tolerance), the absence of dependence and depression of the central nervous system make it an alternative drug to benzodiazepines in children and adolescents. In a study conducted at the Children’s Psychiatry Center [23], Atarax was prescribed for various forms of mental illness in children and adolescents with manifestations of anxiety, irritability, and insomnia-type sleep disorders, and its effectiveness was evaluated. The study included 50 patients aged 5 to 18 years with various forms of mental illness, who were under outpatient observation and treatment at the Children’s Psychiatry CVL. At the end of the 4th week of therapy, there was a decrease in the manifestations of anxiety and various fears noted earlier: falling asleep in the dark, staying at home in the absence of parents, fears of animals, noise of household appliances; in one case, a five-year-old boy could stay at home with a nanny without parents (he had previously had a pronounced affective reaction). In addition, sleep improved in all patients already in the second week of therapy, tearfulness, capriciousness, and irritability were reduced. Simultaneously with the reduction of anxiety, the mood improved in 7 patients with a mixed anxiety and depressive reaction due to adjustment disorder and with a mixed anxiety and depressive disorder, which was associated not with the direct antidepressant effect of Atarax, but with the comorbid dependence of anxiety and depression: anxiety was reduced – depression was gone.
In a comparative study [22] of etifoxine and Atarax (hydroxyzine), the compared anxiolytics demonstrated high efficacy in a wide range of psychopathological manifestations of adjustment disorders and generalized anxiety disorder. The results of therapy with etifoxine and Atarax showed the comparability of the clinical effect of the compared drugs, which was confirmed by a number of formalized indicators. The share of respondents turned out to be comparable: 73.3 and 53. 3% in the HARS assessment; 66.7 and 53.3% in the CGI–S assessment for the groups treated with etifoxine and Atarax. The main clinical effect of the drugs in both groups was a decrease in the severity of manifestations of mental anxiety: the most rapidly reduced symptoms of internal tension (etifoxine – on the 2nd, Atarax – on the 3rd week), reactive (emotional) lability (one of the sub-items of “depressive mood “). In general, similar dynamics of cognitive anxiety was observed in both groups.
In summary, it can be reiterated that hydroxyzine (Atarax) has shown clear advantages over benzodiazepine anxiolytics in the treatment of anxiety disorders. Being as therapeutically effective as benzodiazepine anxiolytics, it does not give the phenomena of “rebound”, does not depress cognitive function and does not cause pathological dependence.

Literature:
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8. Kettelhut B, Berkebile C, Bradley D, Metcalfe D. A double-blind, placebo-controlled, crossover trial of ketotifen versus hydroxyzine in the treatment of pediatric mastocytosis. J Allergy Clin Immunol 1989 May; 83, 5: 866–70)
9. Broder L, Lean N, Hilsenbeck S. A randomized blinded clinical trial comparing delta–9–tetrahydrocannabinol (THC) and hydroxizine (HZ) as antiemetics (AE) for cancer chemotherapy (CT). PROC-AM-ASSOC-CANCER-RES; 1982; 23:514.
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Efficacy and safety of drug therapy for anxiety disorders in diabetic patients | Starostina

Annotation

Purpose.
To study the efficacy and safety of hydroxyzine (G) and tofisopam (T) therapy in patients with diabetes mellitus (DM) with generalized, organic anxiety disorder and subsyndromal anxiety, the overall prevalence of which in DM reaches 45-50%.
Materials and methods.
Open-label, prospective, randomized comparative study in 60 diabetic patients with anxiety disorders (AD) (95% suffered from arterial hypertension). The drugs were prescribed in average therapeutic doses for 3 months, followed by a monthly withdrawal period. The effectiveness of anxiolytics was assessed by the dynamics of reactive anxiety (RT), personal anxiety (LT, Spielberger scale), somatic anxiety symptoms (Hessian Somatic Complaints Questionnaire, HOSF), HbA _1c , systolic, diastolic BP (SBP, DBP) and heart rate .
Results.
Three-month course of anxiolytic therapy (group as a whole) was accompanied by a decrease in HbA _1c from 7.9?1.4 to 7.4?1.4%, total score of GOSS – from 38.0?13.2 to 31.5?12.2, LT – from 52.5?9 .7 to 47.1?8.8 points and to normalization of RT – from 32.3?9.0 to 25.5?9.3 points, SBP – from 141.4?12.4 to 129.8?13, 5 mmHg, DBP – from 82.3?7.4 to 77.8?8.6 mmHg, heart rate – from 76. 3?9.5 to 72.7?5.6( everywhere p Conclusion
Anxiolytic therapy of TR in patients with DM effectively reduces the severity of chronic anxiety, and a stable effect persists for at least 1 month after completion of treatment.Treatment of TR reduces the severity of the most important cardiovascular risk factors in patients with DM (glycated hemoglobin , blood pressure).Mean therapeutic doses of Ataraxa and Grandaxin are well tolerated and safe in patients with DM; withdrawal syndrome does not develop after the end of a three-month course of treatment.Although the effects of treatment with medium therapeutic doses of Ataraxa and Grandaxin in patients with DM are generally comparable, the data obtained show that Atarax can be more active in relation to the psychological component of TR, and Grandaxin – in relation to the somatic (vegetative) component.

The psycho-emotional state of patients with diabetes mellitus (DM) is one of the significant factors affecting the compensation of carbohydrate metabolism, diabetes-related behavior, and diabetes-dependent quality of life [1, 2, 3, 4, 5]. Depression has traditionally been the focus of attention in DM. Anxiety disorders (AD) are much less studied, although their prevalence in DM is higher than that of depressive disorders, and is 40% [6] – 53% [7]. The presence of TR is accompanied by a greater severity of the main cardiovascular risk factors – higher blood pressure (BP) and heart rate, possibly higher HbA1c. The most common chronic anxiety syndromes are generalized TR (GAD) (28%), organic TR (OTR) (22%), and subsyndromal anxiety (STS) (15%) [6]. These types of TR are also a problem because their clinical picture is dominated by vegetative symptoms from the cardiovascular system, gastrointestinal tract and other systems, pain symptoms associated with an increase in muscle tone – all this leads to an increased appeal of patients for medical care, additional examinations, the need for differential diagnosis with autonomic diabetic polyneuropathy, independent cardiac pathology, etc., as well as the appointment of pathogenetically unreasonable, and therefore ineffective methods of therapy. In addition, long-term use of drugs with a risk of addiction and other serious side effects, such as benzodiazepines, phenobarbital (as part of valocordin and corvalol), is very common among somatic patients with TR [8].

In this regard, it seems relevant to study the possibility of anxiolytic (anti-anxiety) therapy in patients with DM. According to the literature, only one randomized controlled trial has been devoted to the treatment of TR in DM, which showed a positive effect of an 8-week course of alprazolam on some anxiety symptoms and HbA1c levels [9]. Effects on cardiovascular risk factors have not been considered; the effects of longer anti-anxiety therapy are also unknown. However, the use of each psychotropic drug in DM requires a prospective safety assessment due to the fact that a number of them can contribute to hyperglycemia.

The aim of our study was to evaluate the efficacy and safety of hydroxyzine (Atarax) and tofisopam (Grandaxin) in DM patients with GAD, OTR, and CCT. These TRs have similar clinical manifestations and patterns of course. The choice of Atarax, an anxiolytic from the H1-blocker group, was dictated by its high clinical efficacy and the possibility of unlimited use, which seems to be a clear advantage in chronic TR [10]. Grandaxin was chosen as the reference drug as the only one in the class of benzodiazepines approved for use within three months. Other benzodiazepine drugs have a large number of side effects, including the risk of dependence, require gradual and slow withdrawal, and, in accordance with international consensus [11], they are not recommended for long-term use in somatic patients (longer than 2-3 weeks) due to high the risk of developing drug dependence.

Materials and methods

The study included 60 patients with DM (type 1 – 6, type 2 – 54, age – 58.2±8.9 [34-73] years, M : F = 7 : 53), who were consecutively recruited in the Department of Therapeutic Endocrinology of MONIKI. Inclusion criteria were: age over 18 years, presence of GAD, GAD (according to ICD-10) or STS (presence of symptoms of GAD/GAD, not reaching the ICD-10 criteria in terms of number or severity), a high level of personal anxiety (PT) or reactive anxiety (RT) on the Spielberger scale, informed consent to participate. The exclusion criteria were reduced visual acuity (impossibility of psychological testing), the presence of a depressive disorder (≥26 points according to the CESD questionnaire + psychiatrist’s opinion), contraindications for taking Atarax or Grandaxin according to the instructions for use.

The study was open, prospective, randomized, comparative, with two parallel groups. After the initial examination with the assessment of inclusion / exclusion criteria, a simple randomization (according to a table of random numbers) was carried out for therapy with either tofisopam (Grandaxin, Egis, Hungary) or hydroxyzine (Atarax, Solvay Pharma, Belgium). Both drugs were prescribed in average therapeutic doses: Grandaxin 50 mg 3 times a day, Atarax 50-75 mg/day in three divided doses (the initial dose of Atarax was 12.5 mg/day followed by an increase of 12.5 mg every 2-3 days). The duration of treatment with anxiolytics was 3 months. Dynamic observation was carried out 1 and 3 months after the start of treatment, after which the drugs were canceled and the examination was repeated a month after the cancellation. Hypoglycemic therapy was not significantly changed during the study.

Initially, the patients underwent a routine examination in an endocrinological hospital using standard clinical and laboratory methods of examination. The level of HbA1c was determined on an automatic analyzer DiaSTAT, Bio-RAD Laboratories, USA (norm<6.2%). The condition of patients before the start of treatment, the effectiveness of anti-anxiety therapy and the condition after 1 month of drug withdrawal were assessed by the dynamics of RT and LT (Spielberger Anxiety/Anxiety Scale), the total score of somatic symptoms of anxiety (Hessian Psychosomatic Complaints Questionnaire, GOSZh), systolic and diastolic BP (SBP and DBP) and HbA1c. TR diagnoses were made according to ICD-10 during a psychiatric consultation, confirming them with the data of the above psychometric examination.

Statistical analysis. The analysis was performed in the population of patients who completed the study according to the protocol (PP). Quantitative variables were processed by descriptive statistics and presented as mean ± standard deviation [median]. Depending on the type of data distribution, a t-test for unrelated samples or the Mann-Whitney test was used to compare the Atarax and Grandaxin groups; to assess the dynamics within groups – the Wilcoxon test or t-test for related samples. The level of statistical significance was taken as p=0.05.

The study was developed and conducted by the staff of the Department of Endocrinology after permission from the ethics committee of MONIKI, with the support of Solvay Pharma in the form of the provision of both drugs.

Results and discussion

In the group as a whole (60 randomized, 47 patients completed the study), a three-month course of anxiolytic therapy was accompanied by a marked decrease in the psychological symptoms of anxiety (sleep disturbances, chronic anxiety, irritability, worries on numerous occasions). The decrease in the psychological component of anxiety was objectively confirmed by the positive dynamics of indicators on the Spielberger scale: normalization of the RT score from 32. 3±9.0 [32.0] to 25.5±9.3 [26.0] and a decrease in the TA score from 52.5±9.7 [52.0] to 47.1±8.8 [47.0] (all p<0.05).

Anxiolytic therapy also had a positive effect on the somatic equivalents of anxiety: the total score of GASS decreased from 38.0±13.2 [37.0] to 31.5±12.2 [32.0]. When analyzing the dynamics on the subscales of GOSS, a significant decrease in the number of complaints from the cardiovascular system, the gastrointestinal tract and the musculoskeletal system was found, which indicated a significant improvement in the well-being of patients due to a decrease in the number and severity of somatic (vegetative and vegetative-painful) symptoms of TR. The severity of complaints according to the “exhaustion” subscale of the HOSF (lethargy, drowsiness, rapid exhaustion, etc.) did not change, but initially they were not pronounced, which is typical for TR, in contrast to depressive disorders.

On the background of anxiolytic therapy in the group as a whole, there was a significant improvement in the compensation of carbohydrate metabolism: the level of HbA1c (%) decreased from 7. 9±1.4 [7.6] to 7.4±1.4 [7.1] (p< 0.05, Wilcoxon test). Thus, in patients who completed the full course of treatment, the absolute decrease in HbA1c was -0.5%, that is, it was not only statistically but also clinically significant.

Initially, 57 of 60 patients (95%) suffered from arterial hypertension, all of them received antihypertensive therapy. After connecting anxiolytic therapy, the most positive dynamics was demonstrated by SBP indicators – from 141.4±12.4 [140.0] to 129.8±13.5 [130.0] mmHg (p<0.01), to a somewhat lesser extent DBP - from 82.3±7.4 [80.0] to 77.8±8.6 [80.0] mm Hg. (p<0.05). Improvement was noted in another factor (or marker, according to some authors) of cardiovascular risk - heart rate: from 76.3±9.5 [77.0] to 72.7±5.6 [72.0 ] (p<0.05, Wilcoxon test everywhere).

Initially, the two groups treated with different anxiolytics were comparable to each other in terms of the main clinical and psychological characteristics. After 3 months of treatment, there was no significant difference between treatment with Atarax and Grandaxin in any of the studied parameters (Table 1).

Small differences were found when comparing the two drugs. So, unlike Grandaxin, Atarax significantly reduced the level of LT, but did not have a pronounced effect on DBP and heart rate. When taking Grandaxin, there was a positive trend in HbA1c, heart rate, which did not reach statistical significance during treatment with Atarax. However, the lack of significant between-group differences in these parameters at the end of the study suggests that these features may have been due to insufficient sample size in each group. This is especially evident when comparing HbA1c scores in the Atarax group, where the actual absolute reduction in HbA1c was -0.8% and was clinically but not statistically significant.

At the end of the three-month course of treatment, both drugs were stopped at the same time without a gradual dose reduction. There were no clinical signs of withdrawal syndrome in any patient. A re-examination 1 month after the anxiolytic withdrawal showed that there was no recurrence of the mental symptoms of TR and their somatic equivalents. All the parameters studied remained stable at the level achieved after treatment, with the exception of DBP, which significantly increased in patients who had previously received Grandaxin, returning to the indicator before the start of treatment: from 76.5±5.6 [75.0] after 3 months treatment up to 81.0±8.3 [80.0] mm Hg. 1 month after cancellation.

Both drugs were well tolerated. Adverse events were observed in the Atarax group in 5 people: 1 episode of arterial hypotension, pulmonary embolism, unstable angina, pain in the legs, symptoms of depression. Of these, 2 patients withdrew from the study due to adverse events (an episode of hypotension and pulmonary embolism). A short-term episode of hypotension, which we regarded as probably associated with taking Atarax, developed in the patient 2 weeks after discharge from the hospital, where she was prescribed combined antihypertensive therapy. The patient did not want to reduce the dose of antihypertensive drugs and decided to cancel Atarax. A fatal pulmonary embolism developed 2 weeks after the start of the drug in a patient with concomitant varicose veins and probably had undiagnosed deep vein thrombosis of the lower extremities. This adverse event was regarded as not related to the drug. Other adverse events in the Atarax group were also regarded as not related to the drug, and the development of depression as a natural course/outcome of TR. In the Grandaxin group, adverse events were observed in 2 people: headache – 1 (possibly associated with taking the drug), depression – 1. By the end of treatment, 7 (23%) people dropped out of the Ataraxin group, 6 (20%) people dropped out of the Grandaxin group , of which 5 in the Atarax group and all 6 in the Grandaxin group dropped out for reasons unrelated to treatment.

The data obtained relate only to the comparison of the average therapeutic doses of the two anxiolytics. If, given the technical feasibility, the study design had increased the daily dose of each to the maximum tolerated dose, the benefit/risk ratio for each drug might have been different.