Daridorexant

Daridorexant comes as a tablet to take by mouth. Take it once a day, if needed. Take 30 minutes before bedtime. You can take with or without food but it may work faster on an empty stomach. Follow the directions on your prescription label. Ask your pharmacist to explain any part you do not understand. Take exactly as directed. Never take more than one dose of daridorexant per day even if you are still having trouble falling asleep or staying asleep.

You could become very sleepy soon after you take daridorexant and remain sleepy for some time. Plan to go to bed right after you take the medication and to stay in bed for at least 7 hours. Do not take if you will be unable to remain asleep for the 7 hours after taking the medication. If you get up too soon after taking daridorexant, you may be too drowsy to drive or perform tasks that require alertness.

Your sleep problems should get better within 7 to 10 days after you start taking daridorexant. Call your doctor if your sleep problems do not improve during this time or if they get worse at any time during your treatment.

Daridorexant 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.

You will be given the Medication Guide when you begin treatment with daridorexant and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

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

Before taking daridorexant,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take while taking daridorexant. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following herbal product may interact with daridorexant: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking daridorexant. Do not start this medication while taking daridorexant without discussing with your healthcare provider.
• tell your doctor if you have narcolepsy (a condition that causes extreme daytime sleepiness). Your doctor will probably tell you not to take daridorexant.
• 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. Also tell your doctor if you have or have ever had depression; mental illness; thoughts of harming or killing yourself or trying to do so; chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways); sleep apnea (condition in which breathing briefly stops many times during the night); any other lung or breathing problems; muscle weakness that happens suddenly; or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking daridorexant, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking daridorexant.
• you should know that daridorexant may cause drowsiness, decreased mental alertness, and coordination problems the day after you take it, and these effects may last several days after stopping the medication. This may increase the risk of falls that can cause serious injury, especially if you are elderly. Daridorexant may also impair your driving skills and increase the risk of falling asleep while driving. Your ability to drive or operate machinery the day after you take daridorexant may be impaired even if you feel fully awake. Do not drive a car, operate machinery, or do any dangerous activity within 7 hours of taking daridorexant and until you feel fully awake. Talk to your doctor about the risks of driving or operating machinery after taking daridorexant.
• do not drink alcohol while you are taking daridorexant. Alcohol can make the side effects from daridorexant worse.
• you should know that some people who took daridorexant got out of bed and drove their cars, prepared and ate food, had sex, made phone calls, or were involved in other activities while partially asleep. After they woke up, these people were usually unable to remember what they had done. Call your doctor right away if you find out that you have been driving or doing anything else unusual while you were sleeping.
• you should know that your behavior and mental health may change while you are taking this medication. These changes may be caused by daridorexant or may be caused by physical or mental illnesses that you already have or that you develop during your treatment. Tell your doctor right away if you experience any of the following: aggressiveness, strange or unusually outgoing behavior, hallucinations (seeing things or hearing voices that do not exist), feeling as if you are outside of your body, memory problems, anxiety, new or worsening depression, thinking about killing yourself or trying to do so, confusion, and any other changes in your usual thoughts, mood, or behavior. Be sure that your family knows which symptoms may be serious so that they can call the doctor if you are unable to seek treatment on your own.

Talk to your doctor about eating grapefruit or drinking grapefruit juice while taking this medicine.

This medication is usually taken as needed. You may take daridorexant even if it is later than the usual time, as long as you will be able to remain in bed for at least 7 hours after you take it.

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

• headache
• fatigue
• daytime sleepiness
• dizziness
• nausea

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

• temporary inability to move or speak for up to several minutes while going to sleep or waking up
• hallucinations (seeing things or hearing voices that do not exist) while going to sleep or waking up
• temporary leg weakness during the day or at nightrash, hives, swelling of the tongue or throat, difficulty swallowing or breathing; or feeling that the throat is closing

Daridorexant 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).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reachhttps://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines websitehttps://goo.gl/c4Rm4pfor more information.

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.

Symptoms of overdose may include:

• sleepiness, muscle weakness, fatigue, headache, disturbance in attention, constipation, loss of voluntary muscle control, inability to speak or move

Keep all appointments with your doctor.

Do not let anyone else take your medication. Daridorexant is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.