Belsomra

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

• drowsiness
• dizziness
• headache
• unusual dreams
• dry mouth
• cough
• diarrhea

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• temporary inability to move or speak for up to several minutes while going to sleep or waking up
• temporary leg weakness during the day or at night

Suvorexant 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 (http://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 light, excess heat and moisture (not in the bathroom).

Store suvorexant in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets are left so you will know if any are missing.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

You should tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you are taking, especially:

• Ketoconazole (Nizoral)
• Itraconazole (Sporanox)
• Posaconazole (Noxafil)
• Clarithromycin (Biaxin)
• Nefazodone (Serzone)
• Ritonavir (Norvir)
• Saquinavir (Invirase)
• Nelfinavir (Viracept)
• Indinavir (Crixivan)
• Boceprevir (Victrelis)
• Telaprevir (Incivek)
• Telithromycin (Ketek)
• Conivaptan (Vaprisol)
• Amprenavir (Agenerase)
• Aprepitant (Emend)
• Atazanavir (Reyataz)
• Ciprofloxacin (Cipro)
• Diltiazem (Cartia)
• Erythromycin (EES)
• Fluconazole (Diflucan)
• Fosamprenavir (Lexiva)
• Imatinib (Gleevec)
• Verapamil (Isoptin)
• Rifampin (Rifadin)
• Carbamazepine (Tegretol)
• Phenytoin (Dilantin)
• Digoxin (Lanoxin)

Belsomra and Alcohol

You should not consume alcohol while taking Belsomra, as it can increase your risk of serious side effects. You should not take Belsomra if you consumed alcohol that evening or before bedtime.

Belsomra and Grapefruit Juice

Consuming grapefruit juice while taking Belsomra may affect how the medication works. You should talk to your doctor about this possible interaction.

Belsomra and Other Interactions

Belsomra may impair your ability to drive or perform other activities that require you to be alert. In one study, male and female participants who took 20 mg of Belsomra exhibited impaired driving performance the next day. You should be especially careful if you take the 20 mg dose of the drug.

Belsomra is a prescription medication used to treat difficulty in falling and staying asleep (insomnia).

Belsomra belongs to a group of drugs called orexin receptor antagonists. These work by altering the signaling (action) of orexin in the brain. Orexins are chemicals that are involved in regulating the sleep-wake cycle and play a role in keeping people awake.

This medication comes in tablet form and is typically taken once a day, at night. 

A common side effect of Belsomra is drowsiness. Do not drive or operate heavy machinery until you know how Belsomra affects you.

You should not use suvorexant if you have narcolepsy.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

If you think you need to take suvorexant for more than 7 to 10 days, be sure to discuss it with your doctor. Insomnia that lasts longer than this may be a sign of another medical problem.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people to become drowsy or less alert than they are normally. Even though suvorexant is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to suvorexant before you drive, use machines, or do anything else that could be dangerous if you are not alert.

If you develop any unusual and strange thoughts or behavior while you are taking suvorexant, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

This medicine may cause you to do things while you are still asleep that you may not remember the next morning. You could drive a car, sleepwalk, have sex, make phone calls, or prepare and eat food while you are asleep or not fully awake. Tell your doctor right away if any of these things occur.

This medicine may cause sleep paralysis (temporary inability to move or talk for up to several minutes while you are going to sleep or wake up) or have cataplexy-like symptoms (temporary weakness in your legs). Tell your doctor right away if you have these symptoms while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine 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:

• 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 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

• It is used to treat sleep problems.

• Store in the original container at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Controlled Substance

Belsomra contains suvorexant, a Schedule IV controlled substance.

Abuse

Abuse of Belsomra poses an increased risk of somnolence, daytime sleepiness, impaired reaction time and impaired driving skills [see Warnings and Precautions (5.1)]. Patients at risk for abuse may include those with prolonged use of Belsomra, those with a history of drug abuse, and those who use Belsomra in combination with alcohol or other abused drugs.

Drug abuse is the intentional non-therapeutic use of an over-the-counter or prescription drug, even once, for its rewarding psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may develop after repeated abuse of a prescription or over-the-counter drug, including: a strong desire to take the drug, difficulties in controlling drug use, persisting in drug use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, as well as the possibility of the development of tolerance or development of physical dependence (as manifest by a withdrawal syndrome). Drug abuse and drug addiction are separate and distinct from physical dependence and tolerance (for example, abuse or addiction are not always accompanied by tolerance or physical dependence).

In an abuse liability study conducted in recreational polydrug users (n=36), suvorexant (40, 80 and 150 mg) produced similar effects as zolpidem (15, 30 mg) on subjective ratings of "drug liking" and other measures of subjective drug effects. Because individuals with a history of abuse or addiction to alcohol or other drugs may be at increased risk for abuse and addiction to Belsomra, follow such patients carefully.

Dependence

Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use. Physical dependence manifests by drug class-specific withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. In completed clinical trials with Belsomra, there was no evidence for physical dependence with the prolonged use of Belsomra. There were no reported withdrawal symptoms after discontinuation of Belsomra.

NDC 0006-0005-30

This package contains 30 Tablets in 3 Blister Cards.
Each Blister Card contains 10 Tablets.

Belsomra®
(suvorexant) tablets
CIV

5 mg

Dispense the accompanying Medication Guide to each patient.

Each tablet contains 5 mg suvorexant.

USUAL DOSAGE: See Package Insert.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled
Room Temperature]. Store in the original package until use, to protect from light and moisture.

Selling or giving away Belsomra® may harm others and is against the law.

Rx only

NDC 0006-0325-30

This package contains 30 Tablets in 3 Blister Cards.
Each Blister Card contains 10 Tablets.

Belsomra®
(suvorexant) tablets
CIV

15 mg

Dispense the accompanying Medication Guide to each patient.

Each tablet contains 15 mg suvorexant.

USUAL DOSAGE: See Package Insert.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled
Room Temperature]. Store in the original package until use, to protect from light and moisture.

Selling or giving away Belsomra® may harm others and is against the law.

Rx only

Belsomra (suvorexant) is a sleep medicine that helps regulate your sleep and wake cycle.

Belsomra is used to treat insomnia (trouble falling asleep or staying asleep).

Belsomra may also be used for purposes not listed in this medication guide.

Common side effects of Belsomra include: drowsiness. See below for a comprehensive list of adverse effects.