Solriamfetol

What is Solriamfetol?

• Solriamfetol (SUNOSI) is a dopamine and norepinephrine reuptake inhibitor (DNRI) used to improve wakefulness in adults with excessive daytime sleepiness that is associated with narcolepsy or obstructive sleep apnea (OSA).

What are the uses of this medicine?

• This medicine is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).

How does this medicine work?

• 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).

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• 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.

Limitations of Use

• SUNOSI is not indicated to treat the underlying airway obstruction in OSA.

What drug interactions can this medicine cause?

• Do not administer SUNOSI concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment.
• 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.
• Use caution when concomitantly administering dopaminergic drugs with SUNOSI.

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

• Prior to initiating treatment with SUNOSI, ensure blood pressure is adequately controlled.

Recommended Dosage Starting dose for patients with narcolepsy:

• 75 mg once daily.

Starting dose for patients with OSA:

• 37.5 mg once daily.
• Dose may be increased at intervals of at least 3 days.
• Maximum dose is 150 mg once daily.

Dosage Recommendations in Patients with Renal Impairment 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.

Administration

• Take SUNOSI exactly as your healthcare provider tells you to. Do not change your dose of SUNOSI without talking to your healthcare provider.
• Your healthcare provider may need to change the dose of SUNOSI until it is the right dose for you.
• Take SUNOSI by mouth 1 time each day when you first wake up. Avoid taking SUNOSI within 9 hours of your planned bedtime. If you take SUNOSI too close to your bedtime, you may find it harder to go to sleep.
• SUNOSI can be taken with or without food.
• Depending on your prescribed dose, your healthcare provider may tell you to swallow your SUNOSI tablet whole or split the SUNOSI tablet in half at the score line in the middle of the tablet. Ask your healthcare provider if you have questions about how to split the SUNOSI tablet in half the right way.
• If you take too much SUNOSI, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 75 mg (functionally scored) and 150 mg

This medicine is available in fallowing brand namesː

• SUNOSI

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• decreased appetite
• problems sleeping
• nausea
• anxiety

SUNOSI may cause serious side effects, including:

• Increased blood pressure and heart rate
• Mental (psychiatric) symptoms including anxiety, problems sleeping (insomnia), irritability and agitation

What special precautions should I follow?

• 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.
• Use caution in treating patients with a history of psychosis or bipolar disorders. Consider dose reduction or discontinuation of SUNOSI if psychiatric symptoms develop.

What to do in case of emergency/overdose?

Management for overdosage

• 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.

Can this medicine be used in pregnancy?

• Available data from case reports are not sufficient to determine drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SUNOSI during pregnancy.
• Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-877-283-6220.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: solriamfetol
• Inactive Ingredients: hydroxypropyl cellulose and magnesium stearate. In addition, the film coating contains: iron oxide yellow, polyethylene glycol, polyvinyl alcohol, titanium dioxide, and talc.

Who manufactures and distributes this medicine?

• Distributed by: Jazz Pharmaceuticals, Inc. Palo Alto, CA 94304
• SUNOSI is a trademark of Jazz Pharmaceuticals, Inc. or its affiliates.

What should I know about storage and disposal of this medication?

• Store SUNOSI at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) (see USP controlled room temperature).

• Dailymed label info on Solriamfetol
• FDA Solriamfetol

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