Sunosi

Narcolepsy, Disorders of Excessive Somnolence, Obstructive Sleep Apnea
Treatment
20 Active Studies for Sunosi

What is Sunosi

SolriamfetolThe Generic name of this drug
Treatment SummarySolriamfetol, also known as Sunosi, is a medication used to reduce daytime sleepiness caused by narcolepsy or obstructive sleep apnea. It works by blocking the reuptake of dopamine and norepinephrine, two neurotransmitters that regulate wakefulness. The drug was approved by the FDA in 2019.
Sunosiis the brand name
image of different drug pills on a surface
Sunosi Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Sunosi
Solriamfetol
2019
4

Effectiveness

How Sunosi Affects PatientsSolriamfetol binds weakly to certain transporters for dopamine and norepinephrine but not serotonin. It does not bind to any other substances or receptors like GABA, adenosine, and histamine. Taking 300mg (twice the maximum recommended dose) of solriamfetol has been associated with an increase in heart rate of 21 beats per minute, and 900mg (six times the maximum recommended dose) has been associated with a 27 beat increase. 300mg of solriamfetol does not significantly affect the QTcF interval.
How Sunosi works in the bodyThe exact way this drug works is not clear, but it may work by blocking the reabsorption of the neurotransmitters dopamine and norepinephrine.

When to interrupt dosage

The suggested dosage of Sunosi depends on the diagnosed medical state, including Daytime Sleepiness, Obstructive Sleep Apnea and Narcolepsy. The quantity of dosage is contingent upon the mode of administration (e.g. Tablet - Oral or Tablet, film coated - Oral) indicated in the table below.
Condition
Dosage
Administration
Narcolepsy
75.0 mg, , 150.0 mg
Tablet, film coated - Oral, , Tablet, film coated, Oral, Tablet, Tablet - Oral
Disorders of Excessive Somnolence
75.0 mg, , 150.0 mg
Tablet, film coated - Oral, , Tablet, film coated, Oral, Tablet, Tablet - Oral
Obstructive Sleep Apnea
75.0 mg, , 150.0 mg
Tablet, film coated - Oral, , Tablet, film coated, Oral, Tablet, Tablet - Oral

Warnings

Sunosi Contraindications
Condition
Risk Level
Notes
Pulse Frequency
Do Not Combine
There are 20 known major drug interactions with Sunosi.
Common Sunosi Drug Interactions
Drug Name
Risk Level
Description
Abemaciclib
Major
The excretion of Abemaciclib can be decreased when combined with Solriamfetol.
Azelastine
Major
Solriamfetol may increase the central nervous system depressant (CNS depressant) activities of Azelastine.
Ethanol
Major
Solriamfetol may increase the central nervous system depressant (CNS depressant) activities of Ethanol.
Iobenguane
Major
Solriamfetol can cause a decrease in the absorption of Iobenguane resulting in a reduced serum concentration and potentially a decrease in efficacy.
Oliceridine
Major
The risk or severity of hypotension, sedation, death, somnolence, and respiratory depression can be increased when Solriamfetol is combined with Oliceridine.
Sunosi Toxicity & Overdose RiskSolriamfetol’s effects are not influenced by age, gender, or race, so no dosage adjustments are necessary for patients over 65. People with kidney problems may have higher levels of the drug in their body and should adjust their dose accordingly. Solriamfetol has been found to cause harm to pregnant animals, so it should not be taken during pregnancy. Breastfeeding infants should be monitored for side effects such as agitation, insomnia, anorexia, and slow weight gain, as the drug can be found in breastmilk. No clinical studies have been conducted on the drug’s safety and effectiveness in children
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Sunosi Novel Uses: Which Conditions Have a Clinical Trial Featuring Sunosi?

Ninety clinical trials are currently evaluating the potential of Sunosi to alleviate Obstructive Sleep Apnea, Narcolepsy and Daytime Sleepiness.
Condition
Clinical Trials
Trial Phases
Obstructive Sleep Apnea
72 Actively Recruiting
Not Applicable, Phase 3, Phase 2, Phase 4, Phase 1, Early Phase 1
Narcolepsy
2 Actively Recruiting
Not Applicable, Phase 1
Disorders of Excessive Somnolence
0 Actively Recruiting

Sunosi Reviews: What are patients saying about Sunosi?

4Patient Review
1/25/2020
Sunosi for Recurring Sleep Episodes During the Day
This medication helps me stay awake for long periods of time without making my anxiety worse, which is a problem I have with most stimulants. However, it doesn't seem to help with my insomnia.
2.7Patient Review
8/5/2021
Sunosi for Recurring Sleep Episodes During the Day
I have narcolepsy and was hoping this medication would be an effective replacement for Adderall. Unfortunately, I have experienced no improvement in my condition after four weeks of use. In fact, I feel worse than before with constant dizziness and a lack of motivation. For anyone suffering from narcolepsy, I would not recommend this treatment.
2Patient Review
1/15/2020
Sunosi for Sleepiness Due To Obstructive Sleep Apnea
1Patient Review
2/12/2020
Sunosi for Recurring Sleep Episodes During the Day
Unfortunately I had to stop using this after just three days because the side effects were too much for me. These included high blood pressure, headaches, and stomach problems like acid reflux.
1Patient Review
8/12/2020
Sunosi for Sleepiness Due To Obstructive Sleep Apnea
I was on Modafinil for a while, but it eventually stopped working. I tried it again after a couple months and found that it worked much better the second time around.
1Patient Review
11/15/2019
Sunosi for Recurring Sleep Episodes During the Day
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Patient Q&A Section about sunosi

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

Is Sunosi a stimulant?

"SUNOSI is not a stimulant; it is a type of medication called a wake-promoting agent. Do not take SUNOSI if you have taken, or stopped taking within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI)."

Answered by AI

What drug is similar to Sunosi?

"Some possible alternative drugs for treating obstructive sleep apnea (OSA) include armodafinil and modafinil."

Answered by AI

What's the difference between Sunosi and Adderall?

"The active drug in Sunosi is solriamfetol, while the active drugs in Adderall are dextroamphetamine and amphetamine. These medications belong to different drug classes."

Answered by AI

What kind of medication is Sunosi?

"What is Sunosi? Sunosi is a prescription medicine used to improve wakefulness in adults with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea."

Answered by AI

Clinical Trials for Sunosi

Image of Star Sleep and Wellness in Dallas, United States.

EVO Sleep and Snore Device for Obstructive Sleep Apnea

18 - 80
All Sexes
Dallas, TX
Title: Severe Label Expansion for EVO Positioner (SLEEP) Study Description: Single-arm study to determine the safety and effectiveness of treating severe obstructive sleep apnea using the EVO Sleep and Snore Device (ProSomnus Sleep Technologies, Pleasanton, CA). Objectives: To determine the safety and effectiveness of the EVO Sleep and Snore Device in individuals with severe obstructive sleep apnea. Endpoints: The primary effectiveness endpoint is the Sher criteria defined as a reduction of Apnea-Hypopnea Index (AHI) of at least 50% from the baseline value and a post-treatment AHI of less than 20 events/hour at 6 months following initiation of Oral Appliance Therapy (OAT) titration. AHI will be collected using HSAT at baseline and 6 months. The primary safety objective is to evaluate safety by summarizing all reported device and/or procedure related adverse events from the time the EVO device is introduced through 6 months. Study Population: A maximum of 49 individuals over the age of 18 years with severe obstructive sleep apnea will be enrolled. Description of Sites/Facilities Enrolling Participants: The study will be conducted at up to four sites, up to two of which could be located outside of the US. Description of Study Device: The study device is the EVO Sleep and Snore Device (ProSomnus Sleep Technologies, Pleasanton, CA). The device is a mandibular repositioning device used to treat obstructive sleep apnea. The device is currently cleared for the treatment of mild and moderate OSA. Study Duration: The time from when the study opens to enrollment until completion of data analyses is estimated to be 15 months.
Recruiting
Has No Placebo
Star Sleep and WellnessErin Mosca, PhDProSomnus Sleep Technologies
Have you considered Sunosi clinical trials? We made a collection of clinical trials featuring Sunosi, we think they might fit your search criteria.Go to Trials
Image of Washington University in St Louis, United States.

MAD vs HGNS for Obstructive Sleep Apnea

18+
All Sexes
St Louis, MO
OSANOVA is a non-randomized clinical trial which aims to compare outcomes of mandibular advancement device (MAD) and hypoglossal nerve stimulation (HGNS) therapies in moderate-to-severe OSA patients who fail, decline, or are intolerant to positive airway pressure (PAP) therapy (referred to as PAP-failing patients). The primary aim of the study is to compare the outcomes between PAP-failing moderate-to-severe OSA patients receiving MAD and those receiving HGNS therapy. Primary Outcome measures include changes in Pittsburgh Sleep Quality Index (PSQI) scores. Secondary aims will help us describe the outcomes between PAP-failing moderate-to-severe OSA patients receiving MAD and those receiving HGNS therapy. Secondary outcome measures include: * adverse events, * Epworth Sleepiness Scale (ESS), * Symptoms of Nocturnal Obstruction and Related Events (SNORE-25), * patient-reported satisfaction, * CGI-Improvement, * the rate of subjects re-selecting the treatment, and * the rate of subjects recommending the treatment. and * changes in sleep study metrics (i.e., AHI, ODI, mean arterial saturation, and Time\<90%),
Recruiting
Has No Placebo
Washington UniversityJay F Piccirillo, MD
Image of University of Alberta, Edmonton, Alberta T6G 2E1 in Edmonton, Canada.

Phototherapy for Obstructive Sleep Apnea

18+
All Sexes
Edmonton, Canada
Obstructive sleep apnea (OSA) is a medical condition where a person has great difficulty with breathing, or stops breathing all together, while asleep. This is a medical condition for which one of the current standard treatments is the use of a custom made dental appliance to help hold the person's airway open while asleep so that the person does not suffocate while sleeping. However, while the majority of OSA patients are able to tolerate the use of oral appliance therapy (OAT) for OSA, some patients are incomplete responders to OAT. These patients, despite having improvement, may still have a disease index above the diagnostic threshold for OSA. Phototherapy (laser therapy) has been used as a method to stiffen the soft palate and parts of the tongue to prevent their collapse. This is a type of cold laser therapy that does not cut/ablate tissue (similar to healing laser therapies). This has been shown to help with both snoring and can also help with OSA, as soft palate and tongue collapse are common areas for where OSA occurs inside the airway. A recent pilot study has shown that phototherapy on its own may be able to treat selected patients with mild, moderate, or severe OSA. To our knowledge, there are no contraindications to combining phototherapy and dental sleep appliance therapy.
Phase 2
Recruiting
University of Alberta, Edmonton, Alberta T6G 2E1
Image of Enjoy Dental in Edmonton, Canada.

Phototherapy for Obstructive Sleep Apnea

18+
All Sexes
Edmonton, Canada
Photobiomodulation (PBM) is a type of light therapy like lasers and LEDs. PBM was previously known by different terms like "low-level laser therapy" (LLLT) or "photobiostimulation." LLLT, despite its name, can also have effects beyond biomodulation, including thermal effects useful in medical imaging and therapy. PBM works by interacting with our biological systems, and its clinical benefits depend on factors like light wavelength, and energy output. PBM has various clinical applications, such as wound healing, pain management, and treatment in sports injuries. It's also used as an adjunct to surgery, reducing risks and improving outcomes in areas like wound healing and inflammation. In oral medicine, PBM is applied to conditions like oral aphthous ulcers and is well-recognized for its positive effects in treatment of oral inflammation for oncology patients. Recent studies indicate that PBM, when administered by trained professionals, can improve sleep quality and reduce snoring/SDB in adults. There's potential for its use in treating obstructive sleep apnea (OSA), showing effectiveness similar to dental sleep appliances but with fewer side effects. This effect seems to be from stabilization of the upper airway. Combining PBM with other therapies, like dental sleep appliances, has shown promise in enhancing effectiveness. However, whether the effect of PBM in stabilizing the upper airway to reduce snoring/SDB can be used in combination with continuous positive airway pressure (CPAP) to decrease CPAP pressures and improve patient compliance has not been explored.
Phase 1
Recruiting
Enjoy Dental
Have you considered Sunosi clinical trials? We made a collection of clinical trials featuring Sunosi, we think they might fit your search criteria.Go to Trials
Image of Medical University of South Carolina in Charleston, United States.

Dexamethasone for Obstructive Sleep Apnea

18+
All Sexes
Charleston, SC
The primary objective of this randomized, placebo-controlled, double-blind study will be to determine if postoperative steroids significantly improve subjects' pain compared to a placebo after undergoing sleep surgery. The secondary objective is to determine if this same course of steroids improves how quickly subjects can tolerate a regular diet after surgery. Further, another secondary objective is to see if this will decrease a patient's postoperative narcotic usage. Investigators also will assess sleepiness, nasal breathing, and eustachian tube dysfunction (ETD) after the procedure using the validated measures Preoperative Epworth Sleepiness Scale (ESS), Nasal Obstruction Symptom Evaluation Survey (NOSE), and Eustachian Tube Dysfunction Questionnaire (ETDQ-7) with an objective to see if these improve more or quicker in patients who receive postoperative steroids. Investigators hypothesize that postoperative steroids will significantly decrease a patient's pain quicker in their recovery, allow them to tolerate more oral intake early in their recovery, allow them to tolerate a regular diet earlier in their recovery, and reduce their postoperative narcotic usage. Investigators hypothesize that postoperative steroids will also improve patients' ESS, NOSE, and ETD scores postoperatively, but Investigators do not believe postoperative steroids will affect the oropharyngeal bleeding rate of patients. This study will provide pilot data to determine if postoperative steroids and what dosage should be part of a standardized postoperative regimen in patients undergoing sleep surgery.
Phase 2
Waitlist Available
Medical University of South CarolinaNicolas Poupore
Image of Rancho Research Institute in Downey, United States.

Intensive CPAP Support for Stroke Patients with Sleep Apnea

18+
All Sexes
Downey, CA
The SCOUTS 3 study aims to test the effectiveness of an intensive CPAP (Continuous Positive Airway Pressure) therapy support program compared to usual care in stroke patients with obstructive sleep apnea (OSA) during inpatient rehabilitation (IPR). The study is a multicenter randomized controlled trial (RCT) involving recruitment of about 250 participants across two institutions and randomization of about 200 participants. It compares an intensive support (IS) program for CPAP use with standard support (SS) to evaluate the effectiveness of the IS intervention in increasing CPAP usage during and after stroke rehabilitation. The Intensive Support (IS) group will receive a multicomponent intensive behavioral adherence program, which includes a CPAP technical support intervention, Motivational Enhancement Therapy (MET), and a Mobile Health intervention. Outcomes measured include CPAP adherence as measured by average nightly use in minutes between randomization and 3 months and the modified Rankin Scale (mRS-9Q) to evaluate stroke recovery.
Recruiting
Has No Placebo
Rancho Research Institute (+1 Sites)Sandeep Khot, MD, MPH
Have you considered Sunosi clinical trials? We made a collection of clinical trials featuring Sunosi, we think they might fit your search criteria.Go to Trials
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