solriamfetol (Rx)

Brand and Other Names:Sunosi
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet: Schedule IV

  • 75mg
  • 150mg

Narcolepsy

Indicated to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy

Initial: 75 mg PO qDay upon awakening

Based on efficacy and tolerability, dose may be doubled at intervals of at least 3 days; not to exceed 150 mg qDay

Dosages >150 mg/day do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions

Obstructive Sleep Apnea

Indicated to improve wakefulness in adults with excessive daytime sleepiness associated with obstructive sleep apnea (OSA)

Initial: 37.5 mg PO qDay upon awakening

Based on efficacy and tolerability, dose may be doubled at intervals of at least 3 days; not to exceed 150 mg qDay

Dosages >150 mg/day do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions

Dosage Modifications

Hepatic impairment: No dosage adjustment required (predominantly eliminated by the kidney)

Renal impairment

  • Mild (eGFR 60-89 mL/min/1.73 m²): No dosage adjustment required
  • Moderate (eGFR 30-59 mL/min/1.73 m²): Initiate at 37.5 mg qDay; based on efficacy and tolerability, may increase to maximum of 75 mg qDay after at least 7 days
  • Severe (eGFR 15-29 mL/min/1.73 m²): 37.5 mg qDay; do not increase dose
  • End-stage renal disease (eGFR <15 mL/min/1.73 m²): Not recommended

Dosing Considerations

Before initiating, ensure blood pressure is adequately controlled

Periodically reassess the need for continued treatment

Limitations of use

  • Not indicated to treat the underlying airway obstruction in OSA
  • Ensure underlying airway obstruction is treated (eg, with continuous positive airway pressure [CPAP]) for at least 1 month before initiating solriamfetol
  • Continue modalities used for treating airway obstruction during solriamfetol treatment; solriamfetol is not a substitute for these modalities

Safety and efficacy not established

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Interactions

Interaction Checker

and solriamfetol

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10% (Narcolepsy)

            Headache (16%)

            1-10% (Narcolepsy)

            Decreased appetite (9%)

            Nausea (7%)

            Anxiety (6%)

            Insomnia (5%)

            Dry mouth (4%)

            Constipation (3%)

            Palpitations (2%)

            Constipation (1%)

            <2%

            • Psychiatric disorders: Agitation, bruxism, irritability
            • Respiratory, thoracic, and mediastinal disorders: Cough
            • Skin and subcutaneous tissue disorders: Hyperhidrosis
            • General disorders and administration site conditions: Feeling jittery, thirst, chest discomfort, chest pain
            • Investigations: Weight decreased

            1-10% (OSA)

            Nausea (8%)

            Decreased appetite (6%)

            Anxiety (4%)

            Diarrhea (4%)

            Irritability (3%)

            Palpitations (3%)

            Abdominal pain (3%)

            Feeling jittery (3%)

            Dizziness (2%)

            Chest discomfort (2%)

            Hyperhidrosis (2%)

            <2%

            • Psychiatric disorders: Bruxism, restlessness
            • Nervous system disorders: Disturbances in attention, tremor
            • Respiratory, thoracic, and mediastinal disorders: Cough, dyspnea
            • Gastrointestinal disorders: Constipation, vomiting
            • Investigations: Weight decreased
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            Warnings

            Contraindications

            Coadministration with MAO inhibitors or within 14 days after discontinuing MAO inhibitor

            Cautions

            Blood pressure and heart rate increase

            • Increases systolic blood pressure, diastolic blood pressure, and heart rate in a dose-dependent fashion
            • Assess blood pressure and control hypertension before initiating treatment
            • Monitor blood pressure regularly during treatment and treat new-onset hypertension and exacerbations of preexisting hypertension
            • Caution in patients at higher risk of major adverse cardiovascular events (MACE), particularly patients with known cardiovascular and cerebrovascular disease, preexisting hypertension, and advanced age
            • If increases in blood pressure or heart rate cannot be managed with dose reduction or other appropriate medical intervention, consider discontinuation of therapy

            Psychiatric symptoms

            • Psychiatric adverse reactions observed during clinical trials, including anxiety, insomnia, and irritability
            • Caution in patients with history of psychosis or bipolar disorders, as these patients were not evaluated in clinical trials
            • Patients with moderate or severe renal impairment may be at a higher risk of psychiatric symptoms because of the prolonged half-life
            • Observe patient for the possible emergence or exacerbation of psychiatric symptoms; reduce dose or consider discontinuing drug if psychiatric symptoms develop

            Drug interaction overview

            • Drugs that increase blood pressure/heart rate: Caution; coadministration might result in pharmacodynamic interactions
            • Dopaminergic drugs: Caution; coadministration might result in pharmacodynamic interactions
            • MAO inhibitors
              • Contraindicated; do not use concomitantly or within 14 days after discontinuing MAO inhibitor
              • Coadministration of MAO inhibitors and noradrenergic drugs may increase risk of hypertensive reaction
              • Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure
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            Pregnancy

            Pregnancy

            Available data from case reports are not sufficient to determine drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcome

            Pregnancy registry

            • Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-877-283-6220 or online at www.SunosiPregnancyRegistry.com

            Animal studies

            • Administration during organogenesis caused maternal and fetal toxicities in rats and rabbits at doses ≥4 and 5 times and was teratogenic at doses 19 and ≥5 times, respectively, the maximum recommended human dose (MRHD) of 150 mg based on mg/m²
            • Administration to pregnant rats during pregnancy and lactation at doses ≥7 times the MRHD based on mg/m² resulted in maternal toxicity and adverse effects on fertility, growth, and development in offspring

            Lactation

            No data are available on the presence of solriamfetol or its metabolites in human milk, effects on breastfed infants, or effects on milk production

            Solriamfetol is present in rat milk; when a drug is present in animal milk, it is likely that the drug will be present in human milk

            Clinical considerations: Monitor breastfed infants for adverse effects (eg, agitation, insomnia, anorexia, reduced weight gain)

            The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Dopamine and norepinephrine reuptake inhibitor (DNRI)

            The mechanism of action of solriamfetol to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy or OSA is unclear

            Efficacy thought to be mediated through its DNRI activity

            Absorption

            Bioavailability: ~95%

            Peak plasma time: 2 hr (fasting)

            Effect of food: Ingestion with high-fat meal resulted in minimal change in peak plasma concentration and AUC; however, peak plasma time delayed ~1 hr

            Distribution

            Vd: ~199 L

            Protein bound: 13.3-19.4%

            Metabolism

            Minimally metabolized in humans

            Elimination

            Half-life: 7.1 hr

            Total clearance: 18.2 L/hr

            Excretion: 95% urine (<1% as minor metabolite)

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            Administration

            Oral Administration

            Take with or without food upon awakening for the day

            Avoid taking within 9 hr of planned bedtime; may interfere with sleep if taken too late in the day

            75-mg tablets are functionally scored and can be split in half (37.5 mg)

            Storage

            Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.