Suvorexant

Suvorexant is part of the drug class:

• Other hypnotics and sedatives

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Suvorexant falls into category C. There are no well-controlled studies that have been done in pregnant women. Suvorexant should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if suvorexant crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using suvorexant.

Do not drive or do anything that requires you to be alert if it has been less than 8 hours since you took suvorexant.

Suvorexant can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine. Until you know how suvorexant will affect you during waking hours, be careful if you drive, operate machinery or do anything that requires you to be awake and alert.

Do not drink alcohol while you are taking suvorexant. Alcohol can increase some of the side effects of this medicine, including drowsiness.

Do not take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety).

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling sleepy the next day.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

In females, the area under the curve (AUC) and maximum plasma concentration (Cmax) increased by 17% and 9%, respectively, following administration of suvorexant 40 mg. The average concentration 9 hours after dosing is 5% higher for females across the dose range studied (10 to 40 mg).

Narcolepsy

Refer to adult dosing.

No dosage adjustment necessary.

Mild or moderate impairment: No dosage adjustment necessary.

Severe impairment: Use is not recommended (has not been studied).

Commonly reported side effects of suvorexant include: drowsiness. See below for a comprehensive list of adverse effects.

Applies to suvorexant: oral tablet

Along with its needed effects, suvorexant may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking suvorexant:

• Sleepiness or unusual drowsiness

• Unusual or abnormal dreams

• Changes in behavior
• discouragement
• fear or nervousness
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• loss of memory
• problems with memory
• seeing, hearing, or feeling things that are not there
• temporary inability to move or talk for up to several minutes while you are going to sleep or wake up
• temporary weakness in your legs
• thoughts of killing oneself
• tiredness
• trouble concentrating

Some side effects of suvorexant may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache

• Body aches or pain
• chills
• cough
• diarrhea
• difficulty with breathing
• dizziness
• dry mouth
• ear congestion
• fever
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

Data not available