solriamfetol

General

Pronunciation:
sol-ri-am-fe-tol


Trade Name(s)

  • Sunosi

Ther. Class.

none assigned

Pharm. Class.

temporary class

dopamine norepinephrine reuptake inhibitors

Controlled Substance Schedule: IV

Indications

Treatment of excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea.

Action

Selective dopamine and norepinephrine reuptake inhibitor.

Therapeutic Effect(s):

Improved wakefulness.

Pharmacokinetics

Absorption: 95% absorbed following oral administration; high-fat food delays absorption.

Distribution: Extensively distributed to tissues.

Metabolism and Excretion: Undergoes minimal metabolism; primarily excreted in urine as unchanged drug (95%).

Half-life: 7 hr.

TIME/ACTION PROFILE (plasma concentrations)

ROUTEONSETPEAKDURATION
POunknown1.25–3 hrunknown

Contraindication/Precautions

Contraindicated in:

  • Concurrent use or use within 14 days of discontinuation of MAO inhibitors;
  • End-stage renal disease.

Use Cautiously in:

  • Cardiovascular disease, cerebrovascular disease, or hypertension;
  • Moderate or severe renal impairment (↑ risk of adverse reactions) (↓ dose recommended)
  • Psychoses or bipolar disorder
  • History of drug (especially stimulants) or alcohol abuse
  • OB:   Use during pregnancy only if potential maternal benefit justifies potential fetal risk
  •  Lactation:  Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
  • Pedi:   Safety and effectiveness not established in children
  • Geri:  Because of reduced renal function, older adults may be at ↑ risk of adverse reactions.

Adverse Reactions/Side Effects

CV: ↑ BP, ↑ HR, palpitations

Derm: ↑ sweating

GI: abdominal pain, constipation, dry mouth, diarrhea, nausea

Metabolic: ↓ appetite

Neuro: headache, anxiety, dizziness, insomnia, irritability

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

  • Concurrent use with or within 14 days of discontinuation of  MAO inhibitors  may ↑ risk of hypertensive crises and is contraindicated.
  • Use cautiously with other  drugs that increase BP or HR.
  •  Dopaminergic drugs  may have synergistic effects.

Route/Dosage

PO (Adults): Narcolepsy– 75 mg once daily; may ↑ dose to 150 mg once daily, if needed, after ≥3 days.  Obstructive sleep apnea– 37.5 mg once daily; may double dose at intervals of at least every 3 days, if needed (max dose = 150 mg/day).

Renal Impairment 
PO (Adults): Moderate renal impairment (eGFR 30–59 mL/min/1.73 m2 ) (for either narcolepsy or obstructive sleep apnea)– 37.5 mg once daily; may ↑ dose to 75 mg once daily after ≥7 days, if needed.  Severe renal impairment (eGFR 15–29 mL/min/1.73 m2 ) (for either narcolepsy or obstructive sleep apnea)– 37.5 mg once daily.

Availability

Tablets: 75 mg, 150 mg

Assessment

  • Observe and document frequency of narcoleptic episodes.
  • Assess BP and control hypertension before starting therapy. Monitor BP during therapy and treat new-onset hypertension and exacerbations of pre-existing hypertension.

Implementation

  • PO Administer once daily upon awakening without regard to food.

Patient/Family Teaching

  • Instruct patient to take solriamfetol as directed. Avoid taking medication within 9 hrs of planned bedtime; may impair ability to fall asleep.
  • Advise patient that sharing this medication with others, even those with same symptoms, is dangerous and illegal. Advise patient that solriamfetol is a drug with known abuse potential. Protect it from theft; store out of sight and reach of children, and in a location not accessible by others.
  • Advise patient to notify health care professional if anxiety, insomnia, irritability, agitation, or signs of psychosis or bipolar disorders occur.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications. If alcohol is used during therapy, intake should be limited to moderate amounts.
  • Rep:  Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Monitor breastfed infants for agitation, insomnia, anorexia and reduced weight gain. Encourage women who become pregnant to enroll in the pregnancy exposure registry to monitor outcomes for women exposed to solriamfetol during pregnancy by calling 1-877-283-6220 or contacting www.SunosiPregnancyRegistry.com.

Evaluation/Desired Outcomes

Improved ability to stay awake.

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