Dopamine and Norepinephrine Reuptake InhibitorPrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Sunosi
SOLRIAMFETOL
1 INDICATIONS AND USAGE SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) [see Clinical Studies ( 14 )] . Limitations of Use SUNOSI is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI for excessive daytime sleepiness...
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Brand names:SUNOSI
Quick Reference
Medicine ClassDopamine and Norepinephrine Reuptake Inhibitor
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- SOLRIAMFETOL
- Medicine class
- Dopamine and Norepinephrine Reuptake Inhibitor
- Brand names
- SUNOSI
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half‑life is about 7
- FDA approved
- Yes
What Is Sunosi?
1 INDICATIONS AND USAGE SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) [see Clinical Studies ( 14 )] . Limitations of Use SUNOSI is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI for excessive daytime sleepiness...
Sunosi (SOLRIAMFETOL) belongs to the Dopamine and Norepinephrine Reuptake Inhibitor class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Sunosi. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Sunosi with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Sunosi is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) [see Clinical Studies ( 14 )] .
Limitations of Use SUNOSI is not indicated to treat the underlying airway obstruction in OSA.
Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI for excessive daytime sleepiness.
Modalities to treat the underlying airway obstruction should be continued during treatment with SUNOSI.
SUNOSI is not a substitute for these modalities.
SUNOSI is a dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).
( 1 ) Limitations of Use SUNOSI is not indicated to treat the underlying airway obstruction in OSA.
Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI for excessive daytime sleepiness.
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION 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. A
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS 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.
Serious
- 5 WARNINGS AND PRECAUTIONS 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.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS 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 wi
How Sunosi Works
12.1 Mechanism of Action The mechanism of action of solriamfetol to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea is unclear. However, its efficacy could be mediated through its activity as a dopamine and norepinephrine reuptake inhibitor (DNRI).
Pharmacokinetics
Absorption
Absorption The oral bioavailability of solriamfetol is approximately 95%
Half-Life
half‑life is about 7
Metabolism
Metabolism Solriamfetol is minimally metabolized in humans
Excretion
Excretion Approximately 95% of the dose was recovered in urine as unchanged solriamfetol, and 1% or less of the dose was recovered as the minor inactive metabolite N‑acetyl solriamfetol in a mass bala
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Sunosiwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
How Supplied SUNOSI is packaged in 30-count white, high density polyethylene (HDPE) bottles. SUNOSI tablets, 75 mg - dark yellow oblong tablet with "75" debossed on one side and a functional score line on the opposite side. NDC 81968-350-01: Bottles of 30 with child-resistant closure SUNOSI tablets,
Frequently Asked Questions
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Sunosi side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Sunosi
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.