Daridorexant Oral Tablet (DARIDOREXANT - ORAL)

Instructions

This medicine may be taken with or without food.

Swallow with a full glass (8 oz) of water unless your doctor gives you different instructions.

Use the medicine 30 minutes before bedtime.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Sleep medicines should only usually be used for a few days at a time. When sleep medicines are used for more than a few weeks, they may not work as well. Speak with your doctor about how often you should take this medicine to help you sleep.

Avoid grapefruit and grapefruit juice while on this medicine.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Contact your doctor if your symptoms do not get better or if they get worse after using this medicine for 7-10 days.

Keep all appointments for medical exams and tests while on this medicine.

Do not take the medicine more than once during 24 hours.

Cautions

Though it helps many people, this medicine may sometimes cause addiction, especially if it is used for a long time. This risk for addiction may be higher if you have a substance use disorder - such as overuse of or addiction to drugs or alcohol. Speak with your doctor about the benefits and risks of using this medicine.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Sleep medicines may sometimes cause you to forget what happened while you were on the medicine. To prevent this, try to use this medicine only when you are able to get a full 8 hours of sleep at night.

Do not use the medication any more than instructed.

If possible, avoid using with alcohol, marijuana, or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

The effects of this medicine can last for hours after you wake up the next day. Do not drive, operate machinery or do anything else that requires alertness until you are able to do so safely.

It is unknown if this medicine passes into breast milk. Ask your doctor before breastfeeding.

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• dizziness
• drowsiness during daytime
• headaches

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• slow or shallow breathing
• changes in memory, mood, or thinking
• confusion
• depression or feeling sad
• fainting
• shortness of breath
• temporary loss of ability to move or talk for up to several minutes while going to sleep or waking up
• unusual behavior during sleep such as walking, talking, cooking, eating, making phone calls or driving
• suicidal thoughts
• weakness

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.