Solriamfetol for the treatment of excessive daytime sleepiness associated with narcolepsy

ABSTRACT

Introduction: Narcolepsy is a chronic disabling condition, excessive daytime somnolence is the main symptoms of it. There is currently no cure for narcolepsy, and hence there is a great need for new treatment options. Solriamfetol is a new selective dopamine and norepinephrine reuptake inhibitor with robust wake-promoting effects. The purpose of this paper is to review solriamfetol.

Areas covered: The chemical property, mechanism of action, pharmacokinetics, clinical efficacy, and safety of solriamfetol are introduced in this paper.

Expert opinion: Solriamfetol can bind to dopamine and norepinephrine transporters and inhibit reuptake of dopamine and norepinephrine. Clinical trials showed that solriamfetol could significantly improve the ability to stay awake and subjective symptoms of excessive sleepiness in adults with narcolepsy. Solriamfetol was well tolerated. Very common adverse reactions were headache, nausea, decreased appetite, insomnia, and anxiety.

KEYWORDS:

• Excessive daytime sleepiness
• narcolepsy
• solriamfetol
• wakefulness；dopamine；norepinephrine

Article Highlights

• Chemical property: molecular formula is C₁₀H₁₅N₂O₂Cl, molecular weight is 230.69.

• Mechanism of action: dopamine and norepinephrine reuptake inhibitor

• Pharmacokinetics: T_max is 2 h, apparent volume of distribution is 199 L, plasma protein binding ranged from 13.3% to 19.4%, t_1/2 is 7.1 h.

• Indication: improving wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy.

• Route of administration: oral administration

• Dose: 75 mg to 150 mg once daily.

• Most frequent side effects: headache, nausea, decreased appetite, insomnia, and anxiety.

• Clinical trials: Phase 2: NCT01485770, NCT01681121.

• Phase 3: NCT02348593.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

A reviewer on this manuscript has disclosed that they have participated in two studies for solriamfetol.

Jazz Pharmaceuticals provided a scientific accuracy review at the request of the journal editor. Changes resulting from comments received from Jazz Pharmaceuticals were made at the discretion of the author on the basis of scientific and editorial merit.

Additional information

Funding

This manuscript was not funded.