solriamfetol hydrochloride: clinical use

Prescribing considerations

• Treatment should be initiated by a clinician experienced in narcolepsy or obstructive sleep apnoea.
• Control pre-existing hypertension and assess cardiovascular risk before treatment.
• Maintain primary therapy for obstructive sleep apnoea.
• Review renal function because exposure increases as renal function declines.
• Use caution with psychosis, bipolar disorder, angle-closure glaucoma, older age, or a history of stimulant or alcohol misuse.
• Reassess residual sleepiness and fitness to drive or operate machinery.

Contraindications and cautions

• Hypersensitivity to solriamfetol or an excipient.
• Myocardial infarction within the previous year.
• Unstable angina, uncontrolled hypertension, serious arrhythmias or other serious cardiac disease.
• Current or recent monoamine oxidase inhibitor treatment.

Monitoring

• Blood pressure and heart rate before treatment and periodically thereafter.
• Anxiety, insomnia, irritability, agitation or worsening psychiatric symptoms.
• Ongoing effectiveness and need for treatment.
• Signs of misuse in people with a relevant history.
• Renal function and cardiovascular tolerability, particularly in older adults or renal impairment.

Clinical pharmacology

Solriamfetol is orally bioavailable, minimally metabolised and predominantly excreted unchanged in urine. Its wake-promoting activity is thought to reflect dopamine and noradrenaline reuptake inhibition; clinically important CYP-mediated pharmacokinetic interactions are considered unlikely.

Formulation and product differences

• The selected film-coated tablet is scored and can be divided into equal halves.
• Other marketed tablet presentations may not be scored.

Tablet

Route: Oral

Strengths: 75 mg, 150 mg