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Solriamfetol for Excessive Sleepiness
Study Summary
This trial is testing whether the medication Solriamfetol can help people who start work early in the morning feel less sleepy during the day.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have been working early morning shifts for at least 3 months before the study.You have recently been diagnosed with a serious problem with drugs or alcohol.Your thyroid stimulating hormone (TSH) level is within the normal range.Your body mass index (BMI) is between 18.5 and 45.You have a history of PKU (phenylketonuria) or are allergic to products containing phenylalanine.You tested positive for alcohol at the screening.I have been on long-term sick leave or haven't worked in the last year.I have taken solriamfetol before.You work an early-morning shift that starts between 3 AM and 6 AM at least 3 days per week.I agree to not donate sperm and to either not have sex or use a condom and additional birth control with female partners during and for 30 days after the study.I do not have serious heart problems like recent heart attacks or uncontrolled high blood pressure.You drink a lot of coffee or plan to drink a lot during the study.I am either unable to have children or I am using effective birth control and will continue for 30 days after the last dose.I feel very sleepy because of my early morning work shifts.You have tested positive for certain drugs in your urine.My kidneys are not working well.You have a heart test that shows a significant problem, as determined by the doctor.I have been diagnosed with a sleep disorder that is not shift work disorder.My thyroid condition has been stable with medication for at least 3 months.I am not pregnant or breastfeeding.I am between 18 and 64 years old.I work at least 20 hours a week.Your test results are outside the normal range and the doctor thinks it's important.You fall asleep in less than 20 minutes during the first 4 scheduled naps.You have a history of regularly using products that contain tetrahydrocannabinol (THC).I do not have any unstable health conditions or mental health issues that could affect my safety in the study.I haven't used an MAOI in the last 14 days and won't during the study.I am not taking any medication that could interfere with the study.I have had weight loss surgery within the last year or ever had a gastric bypass.You have a history of bipolar disorder, schizophrenia, or other psychotic disorders.
- Group 1: Solriamfetol (Sunosi)
- Group 2: Control
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many individuals are being recruited for this experiment?
"Yes, the trial is still recruiting patients. According to clinicaltrials.gov, it was initially launched on July 21st 2021 and most recently renewed on May 23rd 2022. A total of 110 participants are needed from 1 site for this medical research program."
Are further participants being sought for this trial?
"Taking into account the information posted on clinicaltrials.gov, this investigation is in search of participants. The trial was initially unveiled on July 21st 2021 and underwent its most recent update on May 23rd 2022."
Would I be eligible to become a participant in this research project?
"This study requires 110 participants aged 18-64 that suffer from somnolence. Additional eligibility criteria include: both male and female adults, ≥ 20 hours of work per week, 6 to 12 hour shifts, 3 months’ experience with early morning starts (3 AM -6AM) minimum, women must not be pregnant or nursing infants; BMI between 18.5 kg/m2 and 45 kg/m2."
Is this a pioneering experiment of its kind?
"Currently, 3 trials of Solriamfetol Oral Tablet are being conducted in 2 cities and 1 nation. These investigations were first initiated by Jazz Pharmaceuticals in 2021 and included 64 participants in its final Phase 4 clinical trial stage. Since then, a total of 18335 studies have been completed for the drug product."
Has the Solriamfetol Oral Tablet received regulatory assent from the FDA?
"With a score of 3, our team at Power consider Solriamfetol Oral Tablet to be safe as this is an approved Phase 4 trial."
Is there any previous research surrounding the efficacy of Solriamfetol Oral Tablet?
"Currently, Solriamfetol Oral Tablet is the subject of 3 active trials with 1 in its third phase. The majority of tests are located near Boston, Massachusetts although there are other sites conducting studies as well."
Is geriatric participation accepted in this trial?
"According to the available data, only individuals aged 18-64 are eligible for this trial. However, there is a total of 7 different trials targeted towards younger patients and 22 specifically designed for elderly citizens."
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