sunosi
Sunosi (Solriamfetol Hydrochloride) is a dopamine and norepinephrine reuptake inhibitor used to treat Sleepiness.
Solriamfetol Hydrochloride · by Axsome Malta
Key facts
- Active ingredient
- Solriamfetol Hydrochloride
- Form
- Tablet
- Strength
- Solriamfetol Hydrochloride EQ 150MG Base · Solriamfetol Hydrochloride EQ 75MG Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- sleepiness
- Manufacturer
- Axsome Malta
- FDA application
- NDA211230
What is Sunosi?
From the FDA label:SUNOSI contains solriamfetol, a dopamine and norepinephrine reuptake inhibitor (DNRI). Solriamfetol is a phenylalanine derivative with the systematic name ( R )-2-amino-3-phenylpropylcarbamate hydrochloride. The molecular formula is C 10 H 15 N 2 O 2 Cl, and the molecular weight is 230.69. The chemical structure is: Solriamfetol hydrochloride is a white to off-white solid that is freely soluble in water. SUNOSI tablets are intended for oral administration. Each 75 mg SUNOSI film-coated tablet contains 75 mg solriamfetol (equivalent to 89.3 mg solriamfetol hydrochloride). Each 150 mg SUNOSI film-coated tablet contains 150 mg solriamfetol (equivalent to 178.5 mg solriamfetol hydrochloride). The inactive ingredients are hydroxypropyl cellulose and magnesium stearate. In addition, the film coating contains: iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Chemical Structure
How to use
Administer once daily upon awakening. Avoid administration within 9 hours of planned bedtime because of the potential to interfere with sleep. ( 2.2 ) Starting dose for patients with narcolepsy: 75 mg once daily. ( 2.3 ) Starting dose for patients with OSA: 37.5 mg once daily. ( 2.4 ) Dose may be increased at intervals of at least 3 days. ( 2.3 , 2.4 ) Maximum dose is 150 mg once daily. ( 2.3 , 2.4 ) Renal impairment ( 2.5 , 8.6 , 12.3 ): Moderate impairment: Starting dose is 37.5 mg once daily. May increase to 75 mg once daily after at least 7 days. Severe impairment: Starting dose and maximum dose is 37.5 mg once daily. End stage renal disease (ESRD): Not recommended. 2.1 Important Considerations Prior to Initiating Treatment Prior to initiating treatment with SUNOSI, ensure blood pressure is adequately controlled [see Warnings and Precautions ( 5.1 )] . 2.2 General Administration Instructions Administer SUNOSI orally upon awakening with or without food. Avoid taking SUNOSI within 9 hours of planned bedtime because of the potential to interfere with sleep if taken too late in the day. SUNOSI 75 mg tablets are functionally scored tablets that can be split in half (37.5 mg) at the score line. 2.3 Dosage in Narcolepsy Initiate SUNOSI at 75 mg once daily in adults with narcolepsy. The recommended dose range for SUNOSI is 75 mg to 150 mg once daily. Based on efficacy and…
Side effects
The following adverse reactions are discussed in greater detail in other sections of the label: Blood Pressure and Heart Rate Increases [see Warnings and Precautions ( 5.1 )] Psychiatric Symptoms [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (≥ 5% and greater than placebo): headache, nausea, decreased appetite, insomnia, and anxiety. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Axsome Therapeutics, Inc. at 1-800-484-1672 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of SUNOSI has been evaluated in 930 patients (ages 18 to 75 years) with narcolepsy or OSA. Among these patients, 396 were treated with SUNOSI in the 12-week placebo-controlled trials at doses of 37.5 mg (OSA only), 75 mg, and 150 mg once daily. Information provided below is based on the pooled 12-week placebo-controlled studies in patients with narcolepsy or OSA. Most Common Adverse Reactions The most common adverse reactions (incidence ≥ 5% and greater than placebo) reported more frequently with the use of SUNOSI than placebo in either the narcolepsy or OSA populations were…
Warnings
Important safety information
Blood Pressure and Heart Rate Increases : Measure heart rate and blood pressure prior to initiating and periodically throughout treatment. Control hypertension before and during therapy. Avoid use in patients with unstable cardiovascular disease, serious heart arrhythmias, or other serious heart problems. ( 5.1 ) Psychiatric Symptoms : Use caution in treating patients with a history of psychosis or bipolar disorders. Consider dose reduction or discontinuation of SUNOSI if psychiatric symptoms develop. ( 5.2 ) 5.1 Blood Pressure and Heart Rate Increases SUNOSI increases systolic blood pressure, diastolic blood pressure, and heart rate in a dose-dependent fashion [see Adverse Reactions ( 6.1 )] . Epidemiological data show that chronic elevations in blood pressure increase the risk of major adverse cardiovascular events (MACE), including stroke, heart attack, and cardiovascular death. The magnitude of the increase in absolute risk is dependent on the increase in blood pressure and the underlying risk of MACE in the population being treated. Many patients with narcolepsy and OSA have multiple risk factors for MACE, including hypertension, diabetes, hyperlipidemia, and high body mass index (BMI). Assess blood pressure and control hypertension before initiating treatment with SUNOSI. Monitor blood pressure regularly during treatment and treat new-onset hypertension and exacerbations of pre-existing hypertension. Exercise caution when treating patients at higher risk of MACE, particularly patients with known cardiovascular and cerebrovascular disease, pre-existing hypertension, and patients with advanced age. Use caution with other drugs that increase blood pressure and heart rate [see Drug Interactions ( 7.2 )] . Periodically reassess the need for continued treatment with SUNOSI. If a patient experiences increases in blood pressure or heart rate that cannot be managed with dose reduction of SUNOSI or other appropriate medical intervention, consider discontinuation of SUNOSI. Patients with moderate or severe renal impairment may be at a higher risk of increases in blood pressure and heart rate because of the prolonged half-life of SUNOSI [see Dosage and Administration ( 2.5 ), Clinical Pharmacology ( 12.3 )] . 5.2 Psychiatric Symptoms Psychiatric adverse reactions have been observed in clinical trials with SUNOSI, including anxiety, insomnia, and irritability [see Adverse Reactions ( 6.1 )] . SUNOSI has not been evaluated in patients with psychosis or bipolar disorders. Exercise caution when treating patients with SUNOSI who have a history of psychosis or bipolar disorders. Patients with moderate or severe renal impairment may be at a higher risk of psychiatric symptoms because of the prolonged half-life of SUNOSI [see Dosage and Administration ( 2.5 ), Clinical Pharmacology ( 12.3 )] . Patients treated with SUNOSI should be observed for the possible emergence or exacerbation of psychiatric symptoms. If psychiatric symptoms develop in association with the administration of SUNOSI, consider dose reduction or discontinuation of SUNOSI.
Who should not take Sunosi
SUNOSI is contraindicated in patients receiving concomitant treatment with monoamine oxidase (MAO) inhibitors, or within 14 days following discontinuation of monoamine oxidase inhibitor, because of the risk of hypertensive reaction [see Drug Interactions ( 7.1 )] . Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days. ( 4 )
Overdose — what happens if you take too much
A specific reversal agent for SUNOSI is not available. Hemodialysis removed approximately 21% of a 75 mg dose in end stage renal disease patients. Overdoses should be managed with primarily supportive care, including cardiovascular monitoring. Consult with a Certified Poison Control Center at 1-800-222-1222 for latest recommendations.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Drugs that Increase Blood Pressure and/or Heart Rate and Dopaminergic Drugs : Use caution when co-administering with SUNOSI. ( 7.2 , 7.3 ) 7.1 Monoamine Oxidase (MAO) Inhibitors Do not administer SUNOSI concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment. Concomitant use of MAO inhibitors and noradrenergic drugs may increase the risk of a hypertensive reaction. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see Contraindications ( 4 )]. 7.2 Drugs that Increase Blood Pressure and/or Heart Rate Concomitant use of SUNOSI with other drugs that increase blood pressure and/or heart rate has not been evaluated, and such combinations should be used with caution [see Warnings and Precautions ( 5.1 )]. 7.3 Dopaminergic Drugs Dopaminergic drugs that increase levels of dopamine or that bind directly to dopamine receptors might result in pharmacodynamic interactions with SUNOSI. Interactions with dopaminergic drugs have not been evaluated with SUNOSI. Use caution when concomitantly administering dopaminergic drugs with SUNOSI.
Drug class
May treat (source: NIH RxClass)
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Sunosi treat?
- Sunosi (Solriamfetol Hydrochloride) may be used to treat sleepiness, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Sunosi?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Sunosi. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Sunosi?
- Sunosi is marketed by Axsome Malta. You can see Axsome Malta's full profile, rating, and other products on pharmaranks.
- Is Sunosi a brand-name or generic drug?
- Sunosi is a brand-name product with the active ingredient Solriamfetol Hydrochloride.
- Is Sunosi available over the counter?
- No. Sunosi is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Sunosi come in?
- Sunosi is currently marketed as tablet, per the FDA's National Drug Code Directory.
- What class of drug is Sunosi?
- Sunosi is classified as dopamine and norepinephrine reuptake inhibitor, per the FDA's Established Pharmacologic Class.
- Is Sunosi FDA-registered?
- Sunosi is on record with the U.S. FDA under application number NDA211230. You can verify this on its official FDA label.
- Is Sunosi safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Sunosi. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Sunosi?
- Sunosi's side effects are taken directly from its FDA label. From the label: The following adverse reactions are discussed in greater detail in other sections of the label: Blood Pressure and Heart Rate Increases [see Warnings and Precautions ( 5.1 )] Psychiatric Symptoms [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (≥ 5% and greater than placebo): he… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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