Solriamfetol for Pregnancy

Recruiting at 1 trial location

Overseen By Study Director

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Axsome Therapeutics, Inc.

Must be taking: Wake promoting, Stimulants

Disqualifiers: Prior pregnancy in analysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1731 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety of using solriamfetol, a medication for sleepiness, during pregnancy. It focuses on women with narcolepsy (a sleep disorder causing excessive sleepiness) or obstructive sleep apnea (a condition where breathing repeatedly stops and starts during sleep). Participants will be grouped based on their exposure to solriamfetol and whether they have a sleep disorder. Pregnant women diagnosed with narcolepsy or obstructive sleep apnea, or who have taken solriamfetol or similar medications during pregnancy, may be suitable for this study. As a Phase 4 trial, this research seeks to understand how the already FDA-approved solriamfetol benefits more patients, offering valuable insights for those considering participation.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications. It focuses on women who are already taking solriamfetol or similar medications during pregnancy.

What is the safety track record for solriamfetol during pregnancy?

Research has shown that the safety of solriamfetol, the active ingredient in SUNOSI, during pregnancy is not well understood. No studies have specifically focused on pregnant women, resulting in limited information. The drug has been tested in about 930 patients with conditions like narcolepsy or obstructive sleep apnea, but these studies did not include pregnant women.

SUNOSI is not recommended for use during pregnancy or for women who might become pregnant without using effective birth control, due to insufficient detailed safety information. Consequently, the risks of potential birth defects, miscarriage, or other negative effects on the mother or baby remain unclear.

Prospective participants considering a study involving solriamfetol should discuss the benefits and risks with their healthcare provider. This discussion will help in making an informed decision based on the available information and personal health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Solriamfetol, known by its brand name SUNOSI®, because it offers a unique approach to managing narcolepsy and obstructive sleep apnea (OSA) symptoms. Unlike traditional treatments that primarily work by modulating neurotransmitters like dopamine and norepinephrine, Solriamfetol is a dual-acting dopamine and norepinephrine reuptake inhibitor, which could provide enhanced wakefulness with potentially fewer side effects. This distinct mechanism of action sets it apart from standard therapies like modafinil or methylphenidate, which have been the mainstays for these conditions. Additionally, Solriamfetol's potential for a quicker onset of action makes it an attractive option for individuals seeking prompt relief from excessive daytime sleepiness associated with narcolepsy and OSA.

What evidence suggests that solriamfetol exposure during pregnancy is safe for women with narcolepsy or OSA?

Research has shown that solriamfetol can reduce excessive daytime sleepiness in individuals with narcolepsy and obstructive sleep apnea (OSA). In studies, participants with OSA who took solriamfetol remained awake for up to 9 hours after 12 weeks of treatment. Among those with narcolepsy, 30.5% to 49.2% reached normal levels of sleepiness, and 44.1% to 62.7% experienced a noticeable decrease in symptoms. After 6 months of use, patients continued to feel less sleepy compared to those who switched to a placebo. This trial includes a cohort of solriamfetol-exposed participants, both with and without narcolepsy or OSA, to further investigate its effects. However, the safety of solriamfetol during pregnancy remains unclear, and more research is needed to understand its effects on pregnant women. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Inclusion Criteria

I am currently pregnant.

I have narcolepsy, sleep apnea, or took stimulants during pregnancy.

I live in a country where solriamfetol is available for daytime sleepiness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Health information is collected from enrolled pregnant women and their healthcare providers related to their pregnancies and developing babies

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• No treatment
• Other prescription wake-promoting medications or stimulants
• Sunosi (solriamfetol)

How Is the Trial Designed?

Group I: Cohort 5: Other-exposed participants without narcolepsy or OSA Experimental Treatment 1 Intervention

Pregnant women without a diagnosis of narcolepsy or OSA

Group II: Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA Experimental Treatment 1 Intervention

Pregnant women without a diagnosis of narcolepsy or OSA

Group III: Cohort 3: Other-exposed participants with narcolepsy or OSA Experimental Treatment 1 Intervention

Pregnant women with a diagnosis of narcolepsy or OSA

Group IV: Cohort 2: Unexposed participants with narcolepsy or OSA Experimental Treatment 1 Intervention

Pregnant women with a diagnosis of narcolepsy or OSA

Group V: Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA Experimental Treatment 1 Intervention

Pregnant women with a diagnosis of narcolepsy or OSA

Who Is Running the Clinical Trial?

Axsome Therapeutics, Inc.

Lead Sponsor

Trials

34

Recruited

11,600+

Citations

1. sunosi.com sunosi.com/clinical-trial-results-sunosi

Clinical Results for Excessive Daytime Sleepiness (EDS) ... *In a study, all 3 doses showed improved wakefulness through 9 hours at 12 weeks in people with OSA. At the beginning of the study, all groups had an ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8020685/

Clinically relevant effects of solriamfetol on excessive ... In narcolepsy (n = 231), 30.5%–49.2% of participants treated with solriamfetol (across doses) reported ESS scores ≤ 10 and 44.1%–62.7% achieved a ≥ 25% decrease ...

3. sunosihcp.com sunosihcp.com/sunosi-efficacy-excessive-daytime-sleepiness-osa

Efficacy for Excessive Daytime Sleepiness (EDS) Due to OSA After 6 months, patients taking SUNOSI maintained reductions in daytime sleepiness compared to patients who worsened when switched to placebo.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0012369224054709

Results of the Solriamfetol's Effect on Cognitive Health in ... This study found that solriamfetol, compared with placebo, improved cognitive function in participants with cognitive impairment associated with OSA and ...

5. academic.oup.com academic.oup.com/sleep/article/47/Supplement_1/A416/7655009

0970 Real-world Use of Solriamfetol for Excessive Daytime ... Ninety percent of patients achieved ≥2-point reduction in ESS scores from baseline and patients (≥89%) and physicians (≥91%) reported ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06413420

NCT06413420 | SUNOSI® (Solriamfetol) Pregnancy Registry The goal of the registry is to provide information on the safety of solriamfetol during pregnancy so that patients and physicians can weigh the benefits and ...

7. sunosipregnancyregistry.com sunosipregnancyregistry.com/information-for-patients/

Patients IMPORTANT SAFETY CONSIDERATIONS:​​ SUNOSI is not recommended during pregnancy or in women of childbearing potential not using effective contraception. It is ...

8. medicalnewstoday.com medicalnewstoday.com/articles/drugs-sunosi-reproductive-health

Sunosi: Pregnancy and breastfeeding information It's not known whether Sunosi is safe to take during pregnancy. This drug has not been studied during pregnancy.

9. sunosi.com sunosi.com/pi/sunosi.en.USPI.pdf

Prescribing Information The safety of SUNOSI has been evaluated in 930 patients (ages 18 to 75 years) with narcolepsy or OSA. Among these patients, 396 were treated with SUNOSI in the ...

10. ema.europa.eu ema.europa.eu/en/documents/rmp/sunosi-epar-risk-management-plan_en.pdf

Sunosi, INN-solriamfetol - European Medicines Agency to collect and analyse data regarding the safety of Sunosi in exposed pregnant women and their offspring. ... patients with obstructive sleep apnoea (OSA) treated ...