Brisdelle

Premature Ejaculation, Panic Disorder, Social Anxiety Disorder + 7 more

Treatment

3 FDA approvals

20 Active Studies for Brisdelle

What is Brisdelle

Paroxetine

The Generic name of this drug

Treatment Summary

Paroxetine (brand name Paxil) is a type of medication called a selective serotonin reuptake inhibitor (SSRI). It is used to treat anxiety, depression, posttraumatic stress disorder, and menopause symptoms. Paroxetine was approved by the FDA in the 1990s and is more powerful than other SSRIs, making it more likely to cause withdrawal symptoms when stopped. It is generally well-tolerated with a similar side effect profile to other SSRIs. The controlled release version was designed to reduce the risk of nausea.

Paxil

is the brand name

Brisdelle Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Paxil

Paroxetine

1993

429

Approved as Treatment by the FDA

Paroxetine, also known as Paxil, is approved by the FDA for 3 uses which include Vasomotor Symptoms Associated With Menopause and Hot Flashes .

Vasomotor Symptoms Associated With Menopause

Helps manage Vasomotor Symptoms Associated With Menopause

Hot Flashes

Helps manage Vasomotor Symptoms Associated With Menopause

Hot flashes

Helps manage Menopause

Effectiveness

How Brisdelle Affects Patients

Paroxetine is used to treat symptoms of depression, anxiety, posttraumatic stress disorder, obsessive-compulsive disorder, and menopause. It works by blocking the absorption of serotonin in the brain. It usually takes 6 weeks for it to start working. Paroxetine should not be taken with monoamine oxidase inhibitors as it increases the risk of serotonin syndrome. If you have been taking MAO inhibitors, you should wait 2 weeks before taking paroxetine.

How Brisdelle works in the body

Paroxetine helps to increase serotonin levels in the brain by blocking its reabsorption. It does this more effectively than other drugs in its class, such as citalopram and fluvoxamine. While the exact way it relieves the symptoms of menopause is unknown, it may be related to its effects on temperature regulation. Paroxetine also has a weak effect on certain receptors in the brain, such as adrenergic, dopamine, histamine, and serotonin receptors. The delayed effect of paroxetine may be due to its initial action on serotonin neurons, which temporarily inhibit the release of serotonin.

When to interrupt dosage

The instructed measure of Brisdelle is contingent upon the determined condition, such as Post Traumatic Stress Disorder, Depression and Irritable Bowel Syndrome (IBS). The amount of dosage deviates, in accordance with the delivery procedure (e.g. Oral or Capsule - Oral) listed in the table below.

Condition

Dosage

Administration

Generalized Anxiety Disorder

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral

Irritable Bowel Syndrome

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral

Depression

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral

Hot Flashes

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral

Premature Ejaculation

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral

Panic Disorder

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral

Social Anxiety Disorder

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral

Obsessive-Compulsive Disorder

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral

Hot flashes

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral

Post Traumatic Stress Disorder

, 10.0 mg, 20.0 mg, 30.0 mg, 40.0 mg, 12.5 mg, 25.0 mg, 37.5 mg, 7.5 mg, 10.0 mg/mL, 2.0 mg/mL

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Capsule, Capsule - Oral, Suspension, Suspension - Oral

Warnings

Brisdelle has five contraindications, therefore it should not be employed together with the conditions specified in the following table.

Brisdelle Contraindications

Condition

Risk Level

Notes

Pulse Frequency

Do Not Combine

Pulse Frequency

Do Not Combine

Serotonin Syndrome

Do Not Combine

Pulse Frequency

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Paroxetine may interact with Pulse Frequency

There are 20 known major drug interactions with Brisdelle.

Common Brisdelle Drug Interactions

Drug Name

Risk Level

Description

4-Methoxyamphetamine

Major

The metabolism of 4-Methoxyamphetamine can be decreased when combined with Paroxetine.

5-methoxy-N,N-dimethyltryptamine

Major

The metabolism of 5-methoxy-N,N-dimethyltryptamine can be decreased when combined with Paroxetine.

Acebutolol

Major

The metabolism of Acebutolol can be decreased when combined with Paroxetine.

Acetaminophen

Major

The metabolism of Acetaminophen can be decreased when combined with Paroxetine.

Aclidinium

Major

The risk or severity of adverse effects can be increased when Paroxetine is combined with Aclidinium.

Brisdelle Toxicity & Overdose Risk

The toxic dose of paroxetine in mice and rats is 350 mg/kg. The minimum amount of paroxetine that has been reported to cause a fatal outcome is 400 mg, and the most that has been reported for a patient to survive is 2000 mg. Symptoms of an overdose on paroxetine can include fatigue, fever, elevated blood pressure, rapid heartbeat, nausea, vomiting, drowsiness, trembling, dizziness, restlessness, anxiety, headache, sweating, dilated pupils, seizures, tingling sensations, serotonin syndrome, involuntary muscle contractions, and changes in mental status. In some

image of a doctor in a lab doing drug, clinical research

Brisdelle Novel Uses: Which Conditions Have a Clinical Trial Featuring Brisdelle?

539 active clinical trials are presently being conducted to assess the potential of Brisdelle in managing Post Traumatic Stress Disorder, Premature Ejaculation and Menopausal symptoms.

Condition

Clinical Trials

Trial Phases

Social Anxiety Disorder

13 Actively Recruiting

Not Applicable

Depression

204 Actively Recruiting

Phase 3, Phase 2, Not Applicable, Phase 4, Phase 1, Early Phase 1

Obsessive-Compulsive Disorder

61 Actively Recruiting

Not Applicable, Phase 2, Phase 1, Phase 3, Early Phase 1

Generalized Anxiety Disorder

8 Actively Recruiting

Not Applicable, Phase 2, Phase 3

Post Traumatic Stress Disorder

225 Actively Recruiting

Early Phase 1, Not Applicable, Phase 3, Phase 2, Phase 1, Phase 4

Panic Disorder

12 Actively Recruiting

Not Applicable

Irritable Bowel Syndrome

4 Actively Recruiting

Not Applicable, Early Phase 1

Hot Flashes

5 Actively Recruiting

Phase 2, Not Applicable

Premature Ejaculation

0 Actively Recruiting

Hot flashes

21 Actively Recruiting

Not Applicable, Phase 2, Phase 4, Early Phase 1, Phase 3, Phase 1

Brisdelle Reviews: What are patients saying about Brisdelle?

5

Patient Review

9/28/2017

Brisdelle for "Change of Life" Signs

I found huge relief from hot flashes after switching to Brisdell from Combipatch. I also experienced decreased appetite, which is a welcomed change from the ravenous hunger I had on Combipatch.

5

Patient Review

5/12/2017

Brisdelle for "Change of Life" Signs

Brisdelle has been a life-saver for me. I had such bad hot flashes and insomnia that I was never able to get a good night's sleep. This medication really helped within the first week, and the nausea went away after a few weeks. I haven't had many hot flashes since starting this medication, but I have put on 40 pounds; however, I think that is more due to quitting smoking around the same time as starting the medication.

5

Patient Review

6/29/2017

Brisdelle for "Change of Life" Signs

I've been taking this medication for almost a year and it's been great. All my menopause symptoms have disappeared. I'm very grateful.

4.7

Patient Review

6/14/2016

Brisdelle for "Change of Life" Signs

Brisdelle has been a total game-changer for me when it comes to night sweats and my mood swings.

4.7

Patient Review

1/8/2017

Brisdelle for "Change of Life" Signs

I was having hot flashes and they disappeared within the first week of taking this medication. I'm also now able to sleep through the night, which has been amazing. On top of that, it's helped with my anxiety and mild depression. I take the pill five hours before bedtime and have no problem getting up in the morning for work. The only downside is that I feel tired with this med, but I'm maintaining my exercise regime so my weight hasn't changed.

3.7

Patient Review

3/10/2017

Brisdelle for "Change of Life" Signs

I only took the medication for a month. While it did stop the hot flashes (and no weight gain), it made me extremely anxious, irritated all of the time, and almost aggressive. When I discovered it's a low dose of Paxil, I stopped it immediately.

3.3

Patient Review

3/6/2019

Brisdelle for "Change of Life" Signs

Brisdelle was great for my hot flashes and mood in the beginning, but the hot flashes came back with a vengeance. I also gained about 10 pounds because I can't seem to get myself to exercise. I stopped taking it as directed by my OB and within 2 days started having dizziness and muscle spasms in my head.

3.3

Patient Review

10/4/2019

Brisdelle for "Change of Life" Signs

Brisdelle did help with hot flashes, though I experienced some side effects. Hormone replacement ended up being a better solution for me as it addressed more issues.

3

Patient Review

2/13/2017

Brisdelle for "Change of Life" Signs

I first tried this medication a couple years ago and it helped for a while, but then the hot flashes came back. I just started taking it again recently, and they've come back with a vengeance. On top of that, I'm constantly exhausted and have lost interest in many things. I think I'll stop taking it again and see if I can manage the hot flashes through diet. Also, the packaging is really difficult to open.

3

Patient Review

8/21/2016

Brisdelle for "Change of Life" Signs

This treatment initially worked well for me in reducing hot flashes and night sweats. However, over time they have started to become worse again. I have also experienced many days of feeling lethargic and tired while taking this medication, which has led me to discontinue use. So far I haven't had any bad withdrawal symptoms, and I'm hoping that continues.

3

Patient Review

12/16/2016

Brisdelle for "Change of Life" Signs

The packaging of this product is really not up to par.

2

Patient Review

4/10/2016

Brisdelle for "Change of Life" Signs

Brisdelle worked for me for a couple months, but then the hot flashes came back. Additionally, I had some pretty severe side effects while taking it; sweating, nausea, weight gain. But as soon as I switched to Lexapro 5mg, all those problems went away and my hot flashes stopped too. Plus, it's way cheaper--I was paying $60 copayment for Brisdelle but only $2.50 for Lexapro.

1.7

Patient Review

8/4/2017

Brisdelle for "Change of Life" Signs

I've been taking this medication for about a month now, and my hot flashes have actually increased (I'm getting about one an hour). I'm also feeling more agitated than before. I'll try it for a little while longer and see if there's any improvement.

Patient Q&A Section about brisdelle

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Brisdelle the same as Paxil?

"Brisdelle and Paxil are both drugs that contain paroxetine as their active ingredient. Paroxetine is a medication that belongs to a group of drugs called selective serotonin reuptake inhibitors (SSRIs). However, the amount of paroxetine in Brisdelle is lower than the amount in Paxil because Brisdelle and Paxil are used to treat different conditions."

Answered by AI

Does Brisdelle help with anxiety?

"Brisdelle (paroxetine) is not an effective treatment for anxiety. The medication only contains a small amount of paroxetine, which is not enough to treat anxiety."

Answered by AI

What is Brisdelle used for?

"This medication is used to treat hot flashes that occur with menopause by blocking the reuptake of serotonin, a neurotransmitter."

Answered by AI

Does Brisdelle help with sleep?

"Last year, the FDA approved the first non-hormonal treatment for hot flashes – a 7.5-mg formulation of the selective serotonin reuptake inhibitor (SSRI) paroxetine. This drug is marketed under the name of Brisdelle."

Answered by AI

Clinical Trials for Brisdelle

Image of Columbia University Irving Medical Center in New York, United States.

Mindfulness-Based Exposure Therapy for PTSD After Cardiac Arrest

18 - 81
All Sexes
New York, NY

The goal of this clinical trial is to learn if a new therapy called Acceptance- and Mindfulness-Based Exposure Therapy (AMBET) helps treat post-traumatic stress disorder (PTSD) in people who survived a cardiac arrest. This study will compare AMBET to another psychotherapy treatment called Present Centered Therapy (PCT) to see which therapy is more effective in treating PTSD. The main questions it aims to answer are: Does AMBET reduce PTSD symptoms in survivors of cardiac arrest? How do the benefits of AMBET compare to PCT? Participants will: * Be randomly assigned to receive either AMBET or PCT * Attend 12 hours of individual psychotherapy sessions over about 12 weeks * Complete short weekly surveys about their mood and behaviors online * Wear a Fitbit device to track sleep and activity during the study * Do brief homework assignments between sessions

Waitlist Available
Has No Placebo

Columbia University Irving Medical Center

Yuval Neria, PhD

Image of Centre for Addiction and Mental Health in Toronto, Canada.

Psilocybin-Assisted Therapy for Depression and Alcoholism

18 - 65
All Sexes
Toronto, Canada

The goal of this clinical trial is to determine the safety and efficacy of psilocybin assisted Therapy (PAT) in individuals with comorbid Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD). The main question it aims to answer is: \- What is the feasibility and safety of administering PAT in adults with MDD-AUD by evaluating recruitment, retention, tolerability, and safety? Researchers will compare the psilocybin (25 mg) and placebo groups to see if there are any significant differences in frequency of dropouts or serious adverse events. Participants will: * be randomized to receive either psilocybin (25 mg) or placebo * visit the site (in-person and remotely) for a total of 14 times to complete study tasks * receive psilocybin-assisted therapy (PAT) at five various timepoints

Phase 2
Waitlist Available

Centre for Addiction and Mental Health

Image of The University of Texas Health Science Center at Houston in Houston, United States.

Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder

7 - 14
All Sexes
Houston, TX

One of the most common and widely disseminated trauma treatments is Trauma Focused Cognitive Behavioral Therapy (TF-CBT). TF-CBT is a therapist-led, structured and sequential intervention, with treatment organized around P.R.A.C.T.I.C.E. (Psychoeducation, Parent training, Relaxation, Affective Regulation, Cognitive Coping, Trauma Narrative, In-Vivo Exposure, Cognitive Reprocessing, and Enhancing Safety) components. Stepped Care Cognitive Behavioral Therapy for Children after Trauma (SC-CBT-CT) is an alternative delivery system that incorporates the best available evidence on the treatment of childhood Post-traumatic Stress Disorder (PTSD) within a stepped care model and utilizes task-shifting with caregiver involvement, which engages caregivers in actively helping their children. Stepped care approaches are characterized by a personalized approach to care in which a lower intensity (i.e., fewer number of sessions) intervention is initially provided before the child is reevaluated or ''stepped up'' for additional care should symptoms persist. The goal of this study is to assess a personalized modification of SC-CBT-CT for Latino families (pSC-CBT-CT). The hypothesis is that personalizing SC-CBT-CT will improve outcomes for Latino children.

Waitlist Available
Has No Placebo

The University of Texas Health Science Center at Houston

Leslie K Taylor, PhD

Have you considered Brisdelle clinical trials?

We made a collection of clinical trials featuring Brisdelle, we think they might fit your search criteria.
Go to Trials

Have you considered Brisdelle clinical trials?

We made a collection of clinical trials featuring Brisdelle, we think they might fit your search criteria.
Go to Trials
Image of University of Pittsburgh in Pittsburgh, United States.

Pharmacogenomic-Guided Medication Management for Depression

18+
All Sexes
Pittsburgh, PA

The goal of this prospective, randomized clinical trial is to learn whether pharmacogenomic (PGx)-guided comprehensive medication management delivered by pharmacists in community pharmacies will improve antidepressant treatment outcomes. The primary aim is to determine whether comprehensive medication management with review of PGx testing results improves depression symptoms, compared with usual care. Participants 18 years of age or older who have undergone PGx testing (e.g. through an independent biobanking study (Pitt+Me Discovery) who require initiation or adjustment of antidepressant therapy will be randomly assigned to receive either PGx-guided comprehensive medication management or usual care. Those who receive usual care will receive their PGx results at the end of the study. Researchers will compare the groups to assess whether PGx-guided care provided in partnership with community pharmacists and prescribers results in better depression and medication outcomes.

Waitlist Available
Has No Placebo

University of Pittsburgh

Philip E Empey, PharmD, PhD

Image of Health Discovery Building in Austin, United States.

Lumateperone for Depression and Childhood Trauma

21 - 70
All Sexes
Austin, TX

The purpose of this clinical research study is to understand how effective and safe an investigational study drug called lumateperone is and whether it works to reduce the severity of depressive symptoms in adults with Major Depressive Disorder (MDD) and early life trauma. The main questions it aims to answer are: Aim 1: To assess the efficacy of lumateperone 42 mg administered once daily compared with placebo in the treatment of patients with Major Depressive Disorder and early life abuse. Aim 2: To assess neurocircuitry encoding of threat and reward learning as predictors of lumateperone response and as mechanisms of treatment action, and assess the change from pre-dose to post-dose of task-evoked brain activation.

Phase 4
Waitlist Available

Health Discovery Building

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We made a collection of clinical trials featuring Brisdelle, we think they might fit your search criteria.
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