Solriamfetol

Solriamfetol is used to treat excessive daytime sleepiness caused by narcolepsy (a condition that causes excessive daytime sleepiness). Solriamfetol is also used along with breathing devices or other treatments to prevent excessive daytime sleepiness caused by obstructive sleep apnea/hypopnea syndrome (OSAHS; a sleep disorder in which the patient briefly stops breathing or breathes shallowly many times during sleep and therefore doesn't get enough restful sleep). Solriamfetol is in a class of medications called wakefulness promoting agents. It works by increasing the amounts of certain natural substances in the brain that controls sleep and wakefulness.

Solriamfetol comes as a tablet to take by mouth. It is usually taken once a day with or without food as soon as you wake up in the morning. Take solriamfetol at the same time every day. Do not take solriamfetol within 9 hours before you plan to go to bed because it may cause difficulty falling asleep or staying asleep. Do not change the time of day that you take solriamfetol without talking to your doctor. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take solriamfetol exactly as directed.

Your doctor will probably start you on a low dose of solriamfetol and gradually increase your dose, not more than once every 3 days.

Solriamfetol may be habit-forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.

Solriamfetol may decrease your sleepiness, but it will not cure your sleep disorder. Continue to take solriamfetol even if you feel well-rested. Do not stop taking solriamfetol without talking to your doctor.

Solriamfetol should not be used in place of getting enough sleep. Follow your doctor's advice about good sleep habits. Continue to use any breathing devices or other treatments that your doctor has prescribed to treat your condition, especially if you have OSAHS.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

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

Before taking solriamfetol,

• tell your doctor and pharmacist if you are allergic to solriamfetol, any other medications, or any of the ingredients in solriamfetol tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), Rasagiline (Azilect), Safinamide (Xadago), selegiline (Emsam, Zelapar), and tranylcypromine (Parnate).
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications, especially stimulants. Also tell your doctor if you have ever had high blood pressure; a stroke; high cholesterol; chest pain, an irregular heartbeat, a heart attack, or other heart problems; a mental illness such as depression, bipolar disorder (mood that changes from depressed to abnormally excited), mania (frenzied, abnormally excited mood), or psychosis (difficulty thinking clearly, communicating, understanding reality, and behaving appropriately); diabetes, or kidney problems.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking solriamfetol, call your doctor.
• tell your doctor if you are breastfeeding or plan to breastfeed. Solriamfetol may cause reduced weight, agitation, and trouble sleeping in breastfed infants, Talk to your doctor about the best way to feed your infant if you are taking solriamfetol.
• you should know that solriamfetol may cause an increase in your blood pressure. Your doctor may check your blood pressure before starting treatment and regularly while you are taking this medication.
• you should know that solriamfetol may not completely relieve the sleepiness caused by your disorder. Do not drive a car or operate machinery until you know how this medication affects you. If you avoided driving and other dangerous activities because of your sleep disorder, do not start performing these activities again without talking to your doctor even if you feel more alert.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is too late in your waking day (within 9 hours of your planned bedtime), skip the missed dose and continue your regular dosing schedule. If you take solriamfetol too late in your waking day, you may find it harder to go to sleep. Do not take a double dose to make up for a missed one.

Solriamfetol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• dizziness
• difficulty falling asleep or staying asleep
• nausea
• diarrhea
• constipation
• loss of appetite
• stomach pain
• sweating

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• chest pain
• fast, pounding, or irregular heartbeat
• shortness of breath
• slow or difficult speech
• weakness or numbness of an arm or leg
• changes in vision or blurred vision
• increased tiredness
• swelling of the hands, feet, ankles, or lower legs
• frenzied, abnormally excited mood
• anxiety
• irritability
• agitation
• aggressive behavior
• hallucinating (seeing things or hearing voices that do not exist)
• rash or hives

Solriamfetol may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Store solriamfetol in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets are left so you will know if any are missing.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Selling or giving away solriamfetol is against the law. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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