Daridorexant (dar-i-doe-REX-ant)

Treats insomnia (trouble sleeping).

Brand Name(s):

Quviviq

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed. Take this medicine in the evening within 30 minutes before going to bed.
• Take this medicine if you can sleep or rest for at least 7 hours before you need to be active again.
• This medicine works better if you do not take it with food or right after a meal.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• This medicine is used only when you cannot sleep. You do not need to take it on a regular schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how daridorexant works. Tell your doctor if you are using itraconazole or rifampin.
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, breathing or lung problems (including COPD, sleep apnea), or a history of drug or alcohol addiction, daytime sleepiness, depression, mental health problems, or muscle weakness.
• This medicine may cause the following problems:
  • Unusual changes in mood or behavior
  • Sleep paralysis (while you are going to sleep or waking up)
• This medicine may make you drowsy or less alert the next morning. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine may cause you to do things while you are still asleep, including sleepwalking, driving, having sex, making phone calls, or preparing and eating food. You may not remember doing these things the next morning.
• Call your doctor if your symptoms do not improve or if they get worse.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, depression, nervousness, unusual behavior, or thoughts of hurting yourself
• Seeing, hearing, or feeling things that are not there
• Severe confusion, severe drowsiness, muscle weakness
• Temporary inability to move or talk while you are going to sleep or waking up

If you notice these less serious side effects, talk with your doctor:

• Daytime drowsiness
• Headache
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

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