Suvorexant (soo-voe-REX-ant)

Treats insomnia.

Brand Name(s):

Belsomra

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.
• You should not take this medicine if you are not able to 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.
• Missed dose: This medicine is not taken on a regular schedule. Use it only when you cannot sleep.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not remove the tablets from the blister pack until you are ready to use them.

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 foods and medicines can affect how suvorexant works. Tell your doctor if you are using any of the following:
  • Aprepitant, boceprevir, carbamazepine, ciprofloxacin, clarithromycin, conivaptan, digoxin, diltiazem, erythromycin, fluconazole, imatinib, nefazodone, phenytoin, rifampin, telaprevir, telithromycin, verapamil
  • Medicine to treat HIV (such as amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir) or medicine to treat a fungal infection (such as itraconazole, ketoconazole, posaconazole)
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, breathing or lung problems (such as COPD, sleep apnea), or muscle problems or weakness. Tell your doctor if you have a history of alcohol or drug addiction, depression, or mental illness.
• 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 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, such as driving or eating. You may not remember doing these things the next morning. Tell your doctor right away if you learn that this has happened.
• Call your doctor if you still have trouble sleeping after you take this medicine for 7 to 10 days.
• 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.
• 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
• Memory loss
• Seeing, hearing, or feeling things that are not there
• Severe confusion, 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

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