Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 (54)
- 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 topical
cocaine topical 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.
- serdexmethylphenidate/dexmethylphenidate
serdexmethylphenidate/dexmethylphenidate 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)
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)
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
Pregnancy & Lactation
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
Available data from a lactation study in 6 women indicate that this drug is present in human milk; the daily infant dose is 0.112 mg/kg (based on nominal infant weight of 6 kg) and relative infant dose (RID) is approximately 5.5% of maternal weight-adjusted dosage; data are insufficient to determine effects of this drug on breastfed infant 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.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)
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
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