Saphris

Schizophrenia, Bipolar Disorder, Bipolar Disorder + 2 more

Treatment

6 FDA approvals

20 Active Studies for Saphris

What is Saphris

Asenapine

The Generic name of this drug

Treatment Summary

Asenapine is a medication used to treat schizophrenia and bipolar disorder. It is taken under the tongue and works by blocking certain brain chemicals that are involved in these mental health conditions. Asenapine was developed by Schering-Plough and was approved by the FDA in 2009. It can also be prescribed for off-label uses, such as for severe post-traumatic stress disorder nightmares in soldiers.

Saphris

is the brand name

image of different drug pills on a surface

Saphris Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Saphris

Asenapine

2009

35

Approved as Treatment by the FDA

Asenapine, also called Saphris, is approved by the FDA for 6 uses such as Schizophrenia and Bipolar 1 Disorder .

Schizophrenia

Helps manage Schizophrenia

Bipolar 1 Disorder

Helps manage Bipolar 1 Disorder

Mixed manic depressive episode

Helps manage Mixed manic depressive episode

Acute Coryza

Helps manage acute Manic episode

Bipolar Disorder

Helps manage Bipolar 1 Disorder

Bipolar Disorder

Helps manage Mixed manic depressive episode

Effectiveness

How Saphris Affects Patients

Asenapine is a drug that helps to block serotonin, dopamine, noradrenaline, and histamine. It is known to cause drowsiness through its activity at histamine receptors and has been seen to have fewer side effects such as muscle stiffness due to its effect on glutamate transmission in the brain. It does not appear to have any significant influence on muscarinic or cholinergic receptors and so is not likely to cause symptoms such as dry mouth or constipation. Asenapine has a stronger effect on all the mentioned receptors than earlier antipsychotic drugs, except for 5-HT1A and 5-HT

How Saphris works in the body

Asenapine is a drug used to treat schizophrenia. It works by blocking serotonin and dopamine receptors in the brain, which helps increase the amount of dopamine and acetylcholine. This can improve cognitive function and reduce negative symptoms in people with schizophrenia.

When to interrupt dosage

The suggested dose of Saphris is dependent upon the diagnosed illness, such as Bipolar Disorder, Schizophrenia and Acute Coryza. The amount of dosage is articulated in the table below, based on the administration way.

Condition

Dosage

Administration

Schizophrenia

5.0 mg, , 10.0 mg, 2.5 mg, 0.57 mg/hour, 0.38 mg/hour, 0.76 mg/hour

, Sublingual, Tablet, Tablet - Sublingual, Transdermal, Film, extended release, Film, extended release - Transdermal

Acute Coryza

5.0 mg, , 10.0 mg, 2.5 mg, 0.57 mg/hour, 0.38 mg/hour, 0.76 mg/hour

, Sublingual, Tablet, Tablet - Sublingual, Transdermal, Film, extended release, Film, extended release - Transdermal

maintenance therapy

5.0 mg, , 10.0 mg, 2.5 mg, 0.57 mg/hour, 0.38 mg/hour, 0.76 mg/hour

, Sublingual, Tablet, Tablet - Sublingual, Transdermal, Film, extended release, Film, extended release - Transdermal

Bipolar Disorder

5.0 mg, , 10.0 mg, 2.5 mg, 0.57 mg/hour, 0.38 mg/hour, 0.76 mg/hour

, Sublingual, Tablet, Tablet - Sublingual, Transdermal, Film, extended release, Film, extended release - Transdermal

Bipolar Disorder

5.0 mg, , 10.0 mg, 2.5 mg, 0.57 mg/hour, 0.38 mg/hour, 0.76 mg/hour

, Sublingual, Tablet, Tablet - Sublingual, Transdermal, Film, extended release, Film, extended release - Transdermal

Warnings

Saphris Contraindications

Condition

Risk Level

Notes

Severe Hepatic Impairment

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Asenapine may interact with Pulse Frequency

There are 20 known major drug interactions with Saphris.

Common Saphris Drug Interactions

Drug Name

Risk Level

Description

Alfuzosin

Major

Asenapine may increase the hypotensive activities of Alfuzosin.

Amisulpride

Major

Asenapine may increase the antipsychotic activities of Amisulpride.

Aripiprazole lauroxil

Major

Asenapine may increase the orthostatic hypotensive, hypotensive, and antihypertensive activities of Aripiprazole lauroxil.

Artemether

Major

The risk or severity of QTc prolongation can be increased when Asenapine is combined with Artemether.

Azelastine

Major

Asenapine may increase the central nervous system depressant (CNS depressant) activities of Azelastine.

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

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

171 active clinical trials are currently examining the potential of Saphris to improve Schizophrenia, Bipolar Disorder, and Acute Coryza.

Condition

Clinical Trials

Trial Phases

Bipolar Disorder

0 Actively Recruiting

Schizophrenia

97 Actively Recruiting

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

Bipolar Disorder

0 Actively Recruiting

Acute Coryza

1 Actively Recruiting

Not Applicable

maintenance therapy

0 Actively Recruiting

Saphris Reviews: What are patients saying about Saphris?

5

Patient Review

5/12/2016

Saphris for Bipolar I Disorder with Most Recent Episode Mixed

I've only been taking this for five days, but so far I'm really liking it. The numbness has gone away and it doesn't have a bad taste. I do feel a little tired, but that's manageable. I was previously on limictal, but had to stop because of the hallucinations. This seems like a much better option for bipolar patients.

5

Patient Review

7/7/2016

Saphris for Mania associated with Bipolar Disorder

I finally found a drug that helps with my BP-II. I take 10mg of it and it knocks me out within 45 minutes. The only downside is the tongue numbing effect.

4.7

Patient Review

10/19/2016

Saphris for Additional Medications to Treat Depression

I've been taking this for five years now at a dose of 10mg.

4.3

Patient Review

6/15/2016

Saphris for Bipolar I Disorder with Most Recent Episode Mixed

I'm so glad I found this drug! It's been a life-changer for me. The taste isn't that bad, and I can't believe all the complaints. I've only been using it for one month, but I felt myself getting more alive, alert, and happy by day six. If this continues for me, it will be my miracle drug after about 10 mishaps on other meds. Sleep is easy, dreams are amazing, and I don't feel drowsy upon awakening.

4

Patient Review

7/20/2016

Saphris for Bipolar I Disorder with Most Recent Episode Mixed

This medication has been a godsend. I take it before bed and sleep soundly for 8 hours straight. If I have to get up to use the restroom, I don't feel drugged or groggy. When I wake up in the morning, I feel refreshed and alert with no residual sedation from the medication. Additionally, this medication doesn't cause any delusions, manic or depressive symptoms. I also take two antidepressants for my depression, and they work wonders as well. Overall, this medication has allowed me to live a normal life again!

4

Patient Review

2/14/2017

Saphris for Bipolar I Disorder with Most Recent Episode Mixed

I have bipolar disorder type 1 and this medication has been really helpful in managing my symptoms.

4

Patient Review

3/28/2016

Saphris for Mania associated with Bipolar Disorder

4

Patient Review

8/28/2018

Saphris for Additional Medications to Treat Depression

Saphris was working great for me until I realized it was eroding my gums. I'm really disappointed because it had been such a helpful medication.

3.7

Patient Review

9/6/2017

Saphris for Mania associated with Bipolar Disorder

I find it difficult to open and have felt a little itchy since starting if. Otherwise, my sleep has improved incredibly: from 16 hrs/ day to 8-9 hrs/ night and my thinking is clearer. Overall, once you get the package open, it is an incredible med.

3

Patient Review

8/3/2016

Saphris for Bipolar I Disorder with Most Recent Episode Mixed

While this did help with my bipolar disorder and sleep, one of the unfortunate side effects I experienced was tardive dyskinesia.

3

Patient Review

2/2/2019

Saphris for Additional Medications to Treat Depression

I've been on this medication for 8 years now, and I have to say that it's really not been great. I've gained 50lbs, my sex drive is gone, and I just generally feel like a shell of my former self. Medications like this always seem like they're doing more harm than good in the long run.

2.3

Patient Review

9/14/2021

Saphris for Mania associated with Bipolar Disorder

I had a seizure after only taking this medication for one day. I know it's worked well for other people, but please be aware of any potential health issues before taking it. The reaction I had was 6 hours after taking the drug, but I could feel it working within an hour.

2.3

Patient Review

12/12/2017

Saphris for Bipolar I Disorder with Most Recent Episode Mixed

I am experiencing many adverse effects, like tardive dyskinesia. I am having problems with speaking, swallowing and chewing. I think that I will take a different medication.

1

Patient Review

10/31/2018

Saphris for Schizophrenia

I had a really bad reaction to this drug. After only one dose I started feeling incredibly restless and my breathing and speech were both affected.

1

Patient Review

2/24/2022

Saphris for Mania associated with Bipolar Disorder

This was a complete nightmare and did not work at all. If anything, it made my hallucinations worse.

1

Patient Review

11/27/2018

Saphris for Additional Medications to Treat Depression

I was thrilled to find this website. I had been paying almost $2 per pill from Canada, and now 30 10mg tabs of saphris cost me only $6!
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about saphris

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

Is Saphris a mood stabilizer?

"SAPHRIS is a prescription medicine used to treat manic or mixed episodes of bipolar I disorder in adults or children (ages 10-17). When used with a mood stabilizer (lithium or valproate), it can also be used to treat bipolar I disorder in adults."

Answered by AI

Is Saphris used for anxiety?

"Zyprexa may help to decrease hallucinations, prevent mood swings, reduce anxiety, improve thinking, and increase activity levels."

Answered by AI

What are the side effects of Saphris?

"The following side effects may occur: drowsiness, dizziness, lightheadedness, weight gain, numbness or tingling of the mouth (usually goes away within one hour), sores, blisters or pain under the tongue (rarely)."

Answered by AI

What is the drug Saphris used for?

"Asenapine is a medication that is used to treat schizophrenia by working in the brain. It is classified as a second generation antipsychotic (SGA) or atypical antipsychotic. Asenapine helps to improve thinking, mood, and behavior by rebalancing dopamine and serotonin levels."

Answered by AI

Clinical Trials for Saphris

Image of The University of Iowa in Iowa City, United States.

fMRI for Cognitive Flexibility

18 - 35
All Sexes
Iowa City, IA

The goal of this basic experimental research study is to examine how the human thalamus supports flexible thinking and behavior. Specifically, the research aims to elucidate how the mediodorsal (MD) thalamus encodes and updates "context"-the mental framework that determines which rules or actions are relevant in a given situation. This work may contribute to understanding why certain psychiatric conditions, such as schizophrenia and ADHD, involve difficulties with cognitive flexibility and control. The primary research questions are: Does the MD thalamus represent the context that organizes how working memory guides task selection? Does the MD thalamus signal when context needs to be updated after a change in task demands? Do these thalamic representations support generalization to new situations or rules? Participants will complete cognitive tasks while undergoing high-resolution brain imaging using 7-Tesla MRI. The investigators will combine behavioral data, computational modeling, and advanced neuroimaging analyses to examine how the thalamus interacts with the cortex during flexible decision-making.

Waitlist Available
Has No Placebo

The University of Iowa

Image of Vanderbilt Psychiatric Hospital in Nashville, United States.

Repetitive Transcranial Magnetic Stimulation for Schizophrenia

18 - 65
All Sexes
Nashville, TN

The central hypothesis is this: DMN connectivity can be modulated with inhibitory cTBS when delivered on an accelerated treatment schedule. This study seeks to provide evidence that accelerated, network-targeted inhibitory stimulation of the DMN leads to both altered network activity and a concomitant behavioral change in cognitive performance in individuals with schizophrenia and schizoaffective disorder. This study will also compare the effect of inhibitory cTBS in healthy individuals, as it may also lead to both altered network activity and a behavioral change in cognitive performance in individuals without schizophrenia or schizoaffective disorder. If successful, this study will have identified a safe, effective, and broadly applicable treatment for cognitive impairment in schizophrenia that has potential for translation into many other psychiatric and neurodevelopmental disorders, such as autism.

Waitlist Available
Has No Placebo

Vanderbilt Psychiatric Hospital

Heather Ward, MD

Have you considered Saphris clinical trials?

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

Have you considered Saphris clinical trials?

We made a collection of clinical trials featuring Saphris, we think they might fit your search criteria.
Go to Trials
Image of Case Western Reserve University in Cleveland, United States.

Psychosocial Rehabilitation for Schizophrenia

18 - 50
All Sexes
Cleveland, OH

The purpose of this study is to understand how different types of community-based mental health care affect thinking abilities, daily functioning, and brain activity in adults with schizophrenia and related conditions. The investigators are especially interested in learning whether the Clubhouse Model-a structured, supportive community for individuals with mental illness-has unique benefits compared to standard outpatient mental health services. If participants decide to join, they will be asked to complete a total of six study visits with the research team over the course of your participation. Three of these study visits are at the beginning (baseline) and the remaining three are six months later. Two of the three visits will includes interviews, questionnaires, and thinking and memory tasks (cognitive testing) and one session will be an MRI brain scan, which is a safe and non-invasive imaging procedure. The total time required for each visit will be approximately 90 minutes to two hours. Participants may take breaks as needed.

Waitlist Available
Has No Placebo

Case Western Reserve University

Jessica A Wojtalik, PhD

Have you considered Saphris clinical trials?

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