What side effects are associated with this type of intervention?

Common treatments for insomnia, particularly those similar to Solriamfetol (a dopamine and norepinephrine reuptake inhibitor), include medications like modafinil, armodafinil, and other wake-promoting agents. Known side effects of these treatments can include headache, nausea, dizziness, anxiety, and insomnia itself. Additionally, some patients may experience increased heart rate and blood pressure. It is important to consult with a healthcare provider to manage these side effects effectively.

What prior FDA approvals exist?

Solriamfetol, a dopamine and norepinephrine reuptake inhibitor (DNRI), is primarily approved for treating excessive daytime sleepiness in conditions like narcolepsy and obstructive sleep apnea, rather than insomnia. For insomnia, the FDA has approved several other medications, including zolpidem (a non-benzodiazepine hypnotic), eszopiclone (another non-benzodiazepine hypnotic), and ramelteon (a melatonin receptor agonist). These drugs work through different mechanisms compared to DNRIs, focusing on enhancing sleep initiation and maintenance rather than wakefulness. While Solriamfetol is being studied for its potential benefits in sleep disorders, it is not yet approved specifically for insomnia treatment.

What other types of research exist?

Promising novel alternatives to Solriamfetol for insomnia patients include: 1) Cognitive Behavioral Therapy for Insomnia (CBT-I), which has shown efficacy in improving sleep continuity. 2) Sodium oxybate, which has been associated with a reduction in nocturnal sleep disruption. 3) Pitolisant, which has shown efficacy in improving sleep quality in patients with high burden of sleep disorders. These alternatives offer different mechanisms of action and therapeutic approaches that may benefit insomnia patients.

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Central Nervous System Stimulant

Solriamfetol + CBT-I for Insomnia

Phase 4

Recruiting

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of treatment (12 weeks)

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will test if a medication and/or therapy can help treat insomnia and improve sleep quality.

Who is the study for?

This trial is for adults with Insomnia Disorder as per DSM-5, experiencing specific sleep disturbances more than three nights a week for over six months. They must have daytime impairment and prefer to sleep between 10 PM and 8 AM. Excluded are pregnant or breastfeeding individuals, those with unstable health conditions, no internet access, night shift workers, renal issues, severe heart disease or hypertension, other sleep disorders, using certain medications or substances.

What is being tested?

The study tests the effectiveness of solriamfetol (a medication) alone and combined with Cognitive Behavioral Therapy for Insomnia (CBT-I). It aims to see if extending wakefulness can improve sleep quality. Participants will be monitored and may receive either the drug at a specified dose, CBT-I therapy sessions, placebo pills that contain no active drug or just monitoring without intervention.

What are the potential side effects?

Solriamfetol may cause side effects such as headache, nausea, increased blood pressure or heart rate; trouble falling asleep; decreased appetite; anxiety; dizziness; dry mouth. The severity of these side effects can vary among individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of treatment (12 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of treatment (12 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of treatment (12 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sleep Continuity

Secondary study objectives

Adherence to "sleep rescheduling"

Alertness

Daytime Function

+4 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Solriamfetol+ CBT-IExperimental Treatment2 Interventions

Group II: Solriamfetol OnlyExperimental Treatment2 Interventions

Group III: Placebo + CBT-IActive Control2 Interventions

Group IV: Placebo OnlyPlacebo Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavioral Therapy for Insomnia (CBT-I)

2014

N/A

~720

Solriamfetol 75 MG

2021

Completed Phase 3

~70

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for insomnia often target neurotransmitter systems to promote sleep and improve sleep quality. Solriamfetol, a dopamine and norepinephrine reuptake inhibitor (DNRI), works by increasing the levels of these neurotransmitters in the brain, which can enhance wakefulness and alertness. This mechanism is particularly relevant for patients with insomnia who may also experience excessive daytime sleepiness. Other common treatments include melatonin, which regulates the sleep-wake cycle, and benzodiazepines or nonbenzodiazepine receptor agonists, which enhance the effect of the neurotransmitter GABA to induce sedation. Understanding these mechanisms helps tailor treatment to individual patient needs, potentially improving efficacy and minimizing side effects.