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

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            Contraindicated (9)

            • isocarboxazid

              isocarboxazid will increase the level or effect of solriamfetol by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated. Do no use solriamfetol during and/or within 14 days of discontinuing MAOI treatment. MAOIs irreversibly inhibit the enzyme monamine oxidase, an enzyme involved in the degradation of various monoamines, including dopamine and norepinephrine. Solriamfetol increases synaptic dopamine and norepinephrine.

            • linezolid

              linezolid will increase the level or effect of solriamfetol by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated. Do no use solriamfetol during and/or within 14 days of discontinuing MAOI treatment. MAOIs irreversibly inhibit the enzyme monamine oxidase, an enzyme involved in the degradation of various monoamines, including dopamine and norepinephrine. Solriamfetol increases synaptic dopamine and norepinephrine.

            • phenelzine

              phenelzine will increase the level or effect of solriamfetol by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated. Do no use solriamfetol during and/or within 14 days of discontinuing MAOI treatment. MAOIs irreversibly inhibit the enzyme monamine oxidase, an enzyme involved in the degradation of various monoamines, including dopamine and norepinephrine. Solriamfetol increases synaptic dopamine and norepinephrine.

            • procarbazine

              procarbazine will increase the level or effect of solriamfetol by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated. Do no use solriamfetol during and/or within 14 days of discontinuing MAOI treatment. MAOIs irreversibly inhibit the enzyme monamine oxidase, an enzyme involved in the degradation of various monoamines, including dopamine and norepinephrine. Solriamfetol increases synaptic dopamine and norepinephrine.

            • rasagiline

              rasagiline will increase the level or effect of solriamfetol by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated. Do no use solriamfetol during and/or within 14 days of discontinuing MAOI treatment. MAOIs irreversibly inhibit the enzyme monamine oxidase, an enzyme involved in the degradation of various monoamines, including dopamine and norepinephrine. Solriamfetol increases synaptic dopamine and norepinephrine.

            • safinamide

              safinamide will increase the level or effect of solriamfetol by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated. Do no use solriamfetol during and/or within 14 days of discontinuing MAOI treatment. MAOIs irreversibly inhibit the enzyme monamine oxidase, an enzyme involved in the degradation of various monoamines, including dopamine and norepinephrine. Solriamfetol increases synaptic dopamine and norepinephrine.

            • selegiline

              selegiline will increase the level or effect of solriamfetol by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated. Do no use solriamfetol during and/or within 14 days of discontinuing MAOI treatment. MAOIs irreversibly inhibit the enzyme monamine oxidase, an enzyme involved in the degradation of various monoamines, including dopamine and norepinephrine. Solriamfetol increases synaptic dopamine and norepinephrine.

            • selegiline transdermal

              selegiline transdermal will increase the level or effect of solriamfetol by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated. Do no use solriamfetol during and/or within 14 days of discontinuing MAOI treatment. MAOIs irreversibly inhibit the enzyme monamine oxidase, an enzyme involved in the degradation of various monoamines, including dopamine and norepinephrine. Solriamfetol increases synaptic dopamine and norepinephrine.

            • tranylcypromine

              tranylcypromine will increase the level or effect of solriamfetol by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated. Do no use solriamfetol during and/or within 14 days of discontinuing MAOI treatment. MAOIs irreversibly inhibit the enzyme monamine oxidase, an enzyme involved in the degradation of various monoamines, including dopamine and norepinephrine. Solriamfetol increases synaptic dopamine and norepinephrine.

            Serious - Use Alternative (0)

              Monitor Closely (53)

              • albuterol

                albuterol and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • amantadine

                amantadine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • apomorphine

                apomorphine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • arformoterol

                arformoterol and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • benzphetamine

                benzphetamine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • bromocriptine

                bromocriptine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • bupropion

                bupropion and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • cabergoline

                cabergoline and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • caffeine

                caffeine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • cocaine

                cocaine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • dexmethylphenidate

                dexmethylphenidate and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • dextroamphetamine

                dextroamphetamine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • diethylpropion

                diethylpropion and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • dobutamine

                dobutamine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • dopamine

                dopamine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • doxapram

                doxapram and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • droxidopa

                droxidopa and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • ephedrine

                ephedrine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • epinephrine

                epinephrine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • epinephrine racemic

                epinephrine racemic and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • fenoldopam

                fenoldopam and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • formoterol

                formoterol and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • indacaterol, inhaled

                indacaterol, inhaled and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • lasmiditan

                lasmiditan, solriamfetol. Either increases effects of the other by sedation. Use Caution/Monitor. Coadministration of lasmiditan and other CNS depressant drugs, including alcohol have not been evaluated in clinical studies. Lasmiditan may cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions.

              • levalbuterol

                levalbuterol and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • levodopa

                levodopa and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • levodopa inhaled

                levodopa inhaled and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

                levodopa inhaled, solriamfetol. dopaminergic effects. Use Caution/Monitor. Monitor for increased hypertensive effect of solriamfetol if coadministered with dopamine agonists.

              • metaproterenol

                metaproterenol and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • methamphetamine

                methamphetamine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • methylphenidate

                methylphenidate and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • midodrine

                midodrine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • modafinil

                modafinil and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • naphazoline

                naphazoline and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • nicotine gum

                nicotine gum and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • nicotine inhaled

                nicotine inhaled and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • nicotine intranasal

                nicotine intranasal and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • nicotine lozenge

                nicotine lozenge and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • nicotine transdermal

                nicotine transdermal and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • norepinephrine

                norepinephrine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • phendimetrazine

                phendimetrazine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • phentermine

                phentermine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • phenylephrine

                phenylephrine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • phenylephrine PO

                phenylephrine PO and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • pirbuterol

                pirbuterol and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • pramipexole

                pramipexole and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • pseudoephedrine

                pseudoephedrine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • ropinirole

                ropinirole and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • rotigotine

                rotigotine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • salmeterol

                salmeterol and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • terbutaline

                terbutaline and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • umeclidinium bromide/vilanterol inhaled

                umeclidinium bromide/vilanterol inhaled and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • vilanterol/fluticasone furoate inhaled

                vilanterol/fluticasone furoate inhaled and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              • yohimbine

                yohimbine and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              Minor (0)

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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

                Postmarketing Reports

                Hypersensitivity (rash erythematous, rash [unspecified], and urticaria)

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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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                Images

                No images available for this drug.
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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

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                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                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.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
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                QL Quantity Limits
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                ST Step Therapy
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                OR Other Restrictions
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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.