Suvorexant

What is suvorexant?

Suvorexant is a prescription medicine that is used to treat sleep problems.

Description

BELSOMRA tablets contain suvorexant, an orexin receptor antagonist.

Suvorexant is described chemically as:

[(7R)-4-(5-chloro-2-benzoxazolyl) hexahydro-7-methyl-1H-1,4-diazepin-1-yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone

Its empirical formula is C23H23ClN6O2 and the molecular weight is 450.92. Its structural formula is:

Suvorexant is a white to off-white powder that is insoluble in water.

Each film coated tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of suvorexant and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polyvinylpyrrolidone/vinyl acetate copolymer (copovidone).

In addition, the film coating contains the following inactive ingredients: hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The film coating for the 5 mg tablets also contains iron oxide black and iron oxide yellow, and the film coating for the 10 mg tablets also contains FD&C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow.

Mechanism of Action

The mechanism of action of suvorexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.

Before taking suvorexant, tell your doctor:

• If you are allergic to suvorexant; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Falling asleep when you do not expect to (narcolepsy) or liver problems.
• If you are taking any of these drugs: Another drug to help you sleep, boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, or telithromycin.

This is not a list of all drugs or health problems that interact with suvorexant.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take suvorexant with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take suvorexant?

• Tell all of your health care providers that you take suvorexant. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert for at least 8 hours after you take suvorexant. Avoid these tasks or actions until you feel fully awake.
• You may still feel sleepy the day after you take suvorexant. This can affect how you drive and may raise the chance of falling asleep while driving. Call your doctor right away if you drive and you feel sleepy during the day.
• This medicine may be habit-forming with long-term use.
• When sleep drugs are used nightly for more than a few weeks, they may not work as well to help sleep problems. This is known as tolerance. Only use sleep drugs for a short time. If sleep problems last, call the doctor.
• Avoid alcohol while taking suvorexant. Do not take suvorexant if you drank alcohol that evening or before bed.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Some people have done certain tasks or actions while they were not fully awake like driving, making and eating food, and having sex. Most of the time, people do not remember doing these things. Tell your doctor if this happens to you.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• If you are overweight, use suvorexant with care. You could have more side effects.
• If you are a woman, use suvorexant with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using suvorexant while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is suvorexant best taken?

Use suvorexant as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take within 30 minutes of bedtime.
• Take with or without food. If taken with or right after a meal, suvorexant may take longer to work.
• If you still have trouble sleeping after 7 to 10 days, call your doctor.
• Do not take suvorexant unless you can get a full night’s sleep (at least 7 to 8 hours) before you need to be active again.

What do I do if I miss a dose?

• If you take suvorexant on a regular basis, take a missed dose as soon as you think about it.
• If you will not be able to get a full night’s sleep (at least 7 hours) after taking the missed dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Do not take more than 1 dose of suvorexant in the same day.
• Many times suvorexant is taken on an as needed basis. Do not take more often than told by the doctor.

What are the side effects of suvorexant that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
• Feeling confused.
• Change in the way you act.
• Hallucinations (seeing or hearing things that are not there).
• Memory problems or loss.
• Not able to move or speak for up to several minutes while going to sleep or waking up.
• Muscle weakness can happen with suvorexant. This can last from seconds to a few minutes and can happen both at night and during the day. Call your doctor right away if this happens to you.

What are some other side effects of suvorexant?

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:

• 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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out suvorexant?

• 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.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.