Sunosi

Sunosi is a prescription medication used to treat excessive daytime sleepiness from either narcolepsy or obstructive sleep apnea. Sunosi belongs to a group of drugs called dopamine/norepinephrine reuptake inhibitors. Sunosi is thought to work by increasing dopamine and norepinephrine in the brain, which are two chemicals known to regulate sleep patterns. 

This medication comes in tablet form and is taken once each morning.

Common side effects of Sunosi include headache, nausea and decreased appetite.

Sunosi is a prescription medicine used to improve wakefulness in adults with excessive daytime sleepiness that is associated with narcolepsy or obstructive sleep apnea (OSA).

• It is not known if Sunosi is safe and effective in children.
• Sunosi is not for use to treat the underlying cause of airway obstruction in people with OSA. Sunosi does not take the place of using your continuous positive airway pressure (CPAP) machine or other devices that your healthcare provider has prescribed for the treatment of OSA. It is important that you continue to use these treatments as prescribed by your healthcare provider.

Sunosi is a federally controlled substance (CIV) because it contains solriamfetol that can be a target for people who abuse prescription medicines or street drugs.Keep Sunosi in a safe place to protect it from theft. Never give your Sunosi to anyone else, because it may cause death or harm them. Selling or giving away Sunosi may harm others and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Sunosi. See the "Sunosi Precautions" section for more information.

Common side effects of Sunosi include the following:

• headache
• nausea
• decreased appetite 
• insomnia
• anxiety

This is not a complete list of Sunosi side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medications you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Tell your doctor about your medications before, during, and after treatment with Sunosi. Especially tell your doctor if you take:

• MAOI antidepressants (selegiline, isocarboxazid, phenelzine and tranylcypromine)
• drugs that increase heart rate and blood pressure (Adderall, methylphenidate, midodrine)
• other drugs that affect dopamine (opinirole, pramipexole, rotigotine)

This is not a complete list of Sunosi drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Sunosi including the following:

• Increased blood pressure and heart rate. Sunosi can cause blood pressure and heart rate increases that can increase the risk of heart attack, stroke, heart failure and death. Your healthcare provider should check your blood pressure before you start and during treatment with Sunosi. Your healthcare provider may decrease your dose or tell you to stop taking Sunosi if you develop high blood pressure that does not go away during treatment with Sunosi.
• Mental (psychiatric) symptoms including anxiety, problems sleeping (insomnia), irritability and agitation. Tell your healthcare provider if you develop anxiety, problems sleeping, irritability, agitation. Your healthcare provider may change your dose or tell you to stop taking Sunosi if you develop side effects during treatment with Sunosi.

Do not take Sunosi if

• you are pregnant
• you have take MAOI antidepressants in the last 14 days (selegiline, isocarboxazid, phenelzine and tranylcypromine)
• you have end stage renal (kidney) disease
• have uncontrolled or serious heart problems
• you are allergic to any of its ingredients

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Sunosi, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Sunosi, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have heart problems or have had a heart attack
• have had a stroke
• have high blood pressure

• have kidney problems or diabetes

• have high cholesterol in your blood

• have a history of mental health problems, including psychosis and bipolar disorders

• have a history of drug or alcohol abuse or addiction

• are pregnant or planning to become pregnant. It is not known if SUNOSI will harm your unborn baby.

• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given Sunosi and had some babies born with problems and some miscarraiges. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the risks to the unborn child.

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 or contacting the company at www.SunosiPregnancyRegistry.com.

Tell your doctor if you are breastfeeding or planning to breastfeed.

It is not known if Sunosi crosses into human breast milk. Because many medications can cross into human milk and because of the possibility of serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or to stop use of this medication. Your doctor and you will decide is the benefits outweigh the risks of using Sunosi.

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.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. 

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have 
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of Sunosi for the treatment of narcolepsy is 75 mg once daily. The recommended dose of Sunosi for the treatment of excessive daytime sleepiness from obstructive sleep apnea is 37.5 mg once daily. Maximum daily dose for any indication is 150 mg. 

If you take too much Sunosi, call your healthcare provider or local poison control center, or seek emergency medical attention right away.

• Keep this and all medicines out of the reach of children.
• Store Sunosi at room temperature between 68°F to 77°F (20°C to 25°C).