SOLRIAMFETOL

Class

• Dopamine and norepinephrine reuptake inhibitor4

SOLRIAMFETOL commonly prescribed for

(Bold for FDA approved)

How SOLRIAMFETOL works

• Boosts neurotransmitters dopamine and norepinephrine

• Blocks dopamine reuptake pump (dopamine transporter), presumably increasing dopaminergic neurotransmission in brain regions where the dopamine transporter is present (e.g., striatum)

• Blocks norepinephrine reuptake pump (norepinephrine transporter), presumably increasing norepinephrine neurotransmission in the prefrontal cortex and throughout the brain

• Since dopamine is inactivated by norepinephrine reuptake in frontal cortex, which largely lacks dopamine transporters, solriamfetol can increase dopamine neurotransmission in this part of the brain via its actions on the norepinephrine transporter

How long until SOLRIAMFETOL works

• Clinical effects can be seen as early as 1 week

• Can take several weeks for some patients to achieve a clinical response

Notable Side Effects

• Headache, insomnia, anxiety

• Nausea, decreased appetite

• Dose-dependent increase in blood pressure, heart rate

Life Threatening Side Effects

• Theoretical activation of (hypo)mania, anxiety, hallucinations, or suicidal ideation

weight gain

unusual

sedation

unusual

What to do about SOLRIAMFETOL side effects

• Wait

• Lower the dose

• If unacceptable side effects persist, discontinue use

usual dosage range

• Narcolepsy: 75–150 mg once daily upon wakening

• OSA: 75–150 mg once daily upon wakening

Dosage Forms

• Tablet 75 mg (scored), 150 mg

long term use

• Has been evaluated and found safe and effective in trials up to 1 year

• The need for continued treatment should be reevaluated periodically

habit forming

• Schedule IV

• There was no evidence of physiological dependence or withdrawal symptoms in clinical trials

Renal Impairment

• Dose adjustment not necessary in patients with mild renal impairment

• Moderate impairment: initial dose 37.5 mg once daily; can increase to 75 mg once daily after 7 days

• Severe impairment: initial and maximum dose 37.5 mg once daily

• Not recommended for use in end-stage renal disease

Hepatic Impairment

• Dose adjustment not necessary

Cardiac Impairment

• Avoid use in patients with unstable cardiovascular disease, serious heart arrhythmias, or other serious heart problems

Elderly

• Some patients may tolerate lower doses better

Children and Adolescents

• Safety and efficacy have not been established

Pregnancy

• Effective June 30, 2015, the FDA requires changes to the content and format of pregnancy and lactation information in prescription drug labels, including the elimination of the pregnancy letter categories; the Pregnancy and Lactation Labeling Rule (PLLR or final rule) applies only to prescription drugs and will be phased in gradually for drugs approved on or after June 30, 2001

• Controlled studies have not been conducted in pregnant women

• When administered to pregnant rats during organogenesis, the no observed adverse effect level (NOAEL) for malformations is 4 times and for maternal and embryofetal toxicity is approximately 1 times the maximum recommended human dose (MRHD) based on mg/m2 body surface area

• When administered to pregnant rabbits during organogenesis, the NOAEL for malformations and fetal toxicity is approximately 2 times and for maternal toxicity is approximately 5 times the MRHD based on mg/m2 body surface area

• When administered to pregnant rats from gestation day 7 through lactation, maternal toxicity occurred at 7 times the MRHD based on mg/m2 body surface area; at the maternally toxic dose, fetal toxicity occurred; the NOAEL for maternal and developmental toxicity is approximately 2 times the MRHD based on mg/m2 body surface area

Breast Feeding

• Unknown if solriamfetol is secreted in human breast milk, but all psychotropics are assumed to be secreted in breast milk

• Recommended either to discontinue drug or bottle feed