are you looking for a different option to treat your insomnia?

BELSOMRA is a prescription medicine for adults who have trouble falling or staying asleep (insomnia).

Selected Risk Information

Do not take more BELSOMRA than prescribed.

Do not take BELSOMRA unless you are able to stay in bed a full night (at least 7 hours) before you must

be active again.

For additional Selected Risk Information, please see page 11.

Provided as an educational resource by Merck.

Are you looking for a different option to treat your insomnia?

Please read the accompanying Medication Guide and discuss it with

your doctor. The physician Prescribing Information also is available.

Select links to access. 2

Sleep & Wake Pathways . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

BELSOMRA Works Differently . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Clinical Study Results for BELSOMRA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

What to Expect When Starting BELSOMRA With Your Recommended Dose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Finding the Right Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Are Your Sleep Habits Really Wake Habits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Get Answers to Questions on Sleep . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Special Offers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Frequently Asked Questions (FAQs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10

Selected Risk Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12



Do not take BELSOMRA unless you are able to stay in bed a full night (at least 7 hours) before you must be active again.

Take BELSOMRA within 30 minutes of going to bed.


Table of Contents


It is not known if BELSOMRA is safe and effective in children under the age of 18 years.




Selected Risk Information (continued)

BELSOMRA may cause serious side effects that you may not know are happening to you. These side effects include: • sleepiness during the day • not thinking clearly • acting strangely, confused, or upset • “sleep-walking” or doing other activities when you are asleep like eating, talking, having sex, or driving a car. • Call your doctor right away if you find out that you have done any of these activities after taking BELSOMRA.

Do not take BELSOMRA if you fall asleep often at unexpected times (narcolepsy).

BELSOMRA is a controlled substance because it can be abused or cause dependence.


Talk to your doctor about what may be causing your insomnia.

Sleep and Wake Pathways Under Regular Conditions

Insomnia: Could There Be a Problem With Your Wake Pathway?

There are 2 pathways in your brain — a wake pathway and a sleep pathway. Each pathway has neurotransmitters that send signals to determine whether you are awake or asleep.

Under regular conditions, sleep occurs when the wake neurotransmitters turn down and sleep neurotransmitters ramp up and take over, allowing you to fall asleep and stay asleep.

There are many neurotransmitters in the wake and sleep pathways that work together to determine whether you are awake or asleep. Orexin is one of the wake neurotransmitters.

Orexin is a central promoter of wakefulness. Orexin is a neurotransmitter that sends signals to other wake neurotransmitters to support their activity.

Both wake and sleep pathways can play a role in insomnia. Insomnia can occur when your wake and sleep pathways don’t work well together.

Science suggests that when insomnia occurs, your sleep neurotransmitters may be signaling your brain to sleep, but your wake neurotransmitters may not be turning down like they should. When this happens, it can be hard for your brain to transition from the “awake” mode.

This could be contributing to your insomnia, and help explain why you just aren’t getting as much sleep as you want.




Ask your doctor whether BELSOMRA can help you drift off to sleep and stay asleep.

Talk to your doctor about BELSOMRA, a sleep aid that works differently.

BELSOMRA works differently from other sleep medications. By targeting the action of orexin, a neurotransmitter that signals your brain to be awake, BELSOMRA quiets the action of orexin from sending wake signals to other parts of the brain. This is how BELSOMRA is thought to help you fall and stay asleep.


Before taking BELSOMRA, tell your doctor about all of your medical conditions, including if you: • have a history of depression, mental illness, or suicidal thoughts • have a history of drug or alcohol abuse or addiction • have a history of a sudden onset of muscle weakness (cataplexy) • have a history of falling asleep often at unexpected times (narcolepsy) or daytime sleepiness • have lung or breathing problems • have liver problems • are pregnant or plan to become pregnant • are breastfeeding or plan to breastfeed.


BELSOMRA targets and inhibits the action of orexin.

Orexin Neurons

Awake Mode BELSOMRA is FDA approved for adults who have trouble falling asleep (sleep onset) and staying asleep (sleep maintenance).

In clinical studies, BELSOMRA demonstrated that:

People fell asleep faster and stayed asleep longer when using BELSOMRA compared to patients taking placebo.

There was no evidence of physical dependence after prolonged use of BELSOMRA. There were no reported withdrawal symptoms after discontinuation.

BELSOMRA is a federally controlled substance because it can be abused or cause dependence. Keep BELSOMRA in a safe place to prevent misuse and abuse. Selling or giving away BELSOMRA may harm others and is against the law. Tell your doctor if you have ever abused or have been dependent on alcohol, prescription medicines, or street drugs.

BELSOMRA® (suvorexant) Works Differently Clinical Study Results for BELSOMRA

Not actual size shown. For illustration purposes only.

The recommended dose is 10 mg.*





Medicines can interact with each other, sometimes causing serious side effects. Do not take BELSOMRA with other medicines that can make you sleepy unless your doctor tells you to.

Do not drink alcohol while taking BELSOMRA. It can increase your chances of getting serious side effects.

Do not drive, operate heavy machinery, do anything dangerous, or do other activities that require clear thinking after taking BELSOMRA.

You may still feel drowsy the next day after taking BELSOMRA. Do not drive or do other dangerous activities until you feel fully awake.

How should I take BELSOMRA?

Take BELSOMRA exactly as your doctor tells you to take it.

Only take BELSOMRA 1 time each night, if needed, within 30 minutes of going to bed.

Only take BELSOMRA when you can get a full night’s sleep (at least 7 hours).

Do not take BELSOMRA if you drank alcohol that evening or before bed.

BELSOMRA may be taken with or without a meal. However, BELSOMRA may take longer to work if you take it with or right after meals.

Call your doctor if your insomnia (sleep problem) worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

If you take too much BELSOMRA, call your doctor right away or get emergency treatment.


What to Expect When Starting BELSOMRA® (suvorexant) With Your Recommended Dose

Finding the Right Dose

The way you feel when you fall asleep with BELSOMRA may be different from what you have experienced in the past or what you expected. Therefore, it is important to give BELSOMRA an adequate trial period. Try BELSOMRA for a few nights to a week to see how it works for you.

Contact your doctor if your insomnia worsens or is not better within 7 to 10 days, as another condition may be causing your sleep problem.

Your insomnia is as individual as you are, and medicines work differently for different people, so BELSOMRA comes in multiple strengths.

Tell your doctor if you’re still not sleeping well with 10 mg.* If your current dose is well tolerated and you’re not getting the sleep you want, your doctor may suggest that you increase your dose. Do not take more than 20 mg of BELSOMRA in 1 day.

*5 mg is the recommended dose for certain patients, and these patients should generally not exceed 10 mg.

Start off right—register for personalized support and resources at BelsomraBeginnings.com




Did You Know? The type of light, called blue light, emitted from electronic devices like your smartphone or tablet, may block your brain from producing a hormone that helps you to sleep. Try turning off electronics at least 1 hour before going to bed.

Are Your Sleep Habits Really Wake Habits?

Are your sleep habits keeping you up? You may be unintentionally stimulating your “awake” mode and sending signals telling your brain to ramp up rather than wind down at bedtime.

Adopt good sleep habits and learn more about yours by visiting belsomra.com. On the site, you can take a quiz to create your Personalized Sleep Profile, and you’ll receive customized tips with ways to help tackle the habits that come between you and your sleep. Because BELSOMRA is believed to turn down wake messages, going to bed and allowing your body to go to sleep without engaging in activities that keep your mind occupied is recommended when taking BELSOMRA.

After you get your sleep profile and customized tips, you can choose to take on the 10-Day Challenge to change your current habits and help move toward a better night’s sleep.

For Selected Risk Information, please see page 11.




Get Answers to Questions on Sleep

There are things your doctor needs to know to assess the extent and impact of your insomnia. Your doctor will need to know how many hours you are sleeping and the specific symptoms you’re having. Fill out the checklist below and share your answers with your doctor at your next appointment. The better your conversation with your doctor, the sooner your doctor can help you find a way to improve your sleep.

How many nights per week do

you have trouble sleeping?

Do you have trouble

falling asleep?

Do you have trouble

staying asleep?

Do you consistently wake up much

earlier than you want to?

How many hours of sleep do you get when

you have trouble sleeping (total sleep time)?

What parts of your life are impacted by your lack of sleep?

YES

YES

YES

NO

NO

NO

HOURS

NIGHTS

Fill out this checklist, then talk to your doctor about your specific symptoms.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .


BELSOMRA may cause serious side effects, including: • abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions • memory loss • anxiety • temporary inability to move or talk (sleep paralysis) for up to several minutes while you are going to sleep or waking up • temporary weakness in your legs that can happen during the day or at night.

The most common side effects of BELSOMRA include drowsiness the next day after you take BELSOMRA.






Special Offers for BELSOMRA® (suvorexant)

If you and your doctor agree BELSOMRA is right for you, you may be eligible to receive a free 10-day trial supply of BELSOMRA.

Eligible patients can view and print a Free Trial Offer for BELSOMRA at belsomrafreetrial.com.

Take it along with a valid signed prescription to any participating eligible retail pharmacy.

† Not all patients are eligible. Certain restrictions apply.

Please see Terms and Conditions.

Eligible privately insured patients may save on their prescriptions for BELSOMRA.

Eligible patients can review the Terms and Conditions, and view and print the Savings Coupon for BELSOMRA, or save the Savings Coupon to their mobile device, at belsomrasavings.com.

Take it along with a valid signed prescription to any participating eligible pharmacy.

‡ Not all patients are eligible. Certain restrictions apply.

Please see Terms and Conditions.

Register at belsomra.com to get support and additional information about BELSOMRA.

Talk to your doctor or visit belsomra.com for details.

Sign Up for Support

MULTI-USE SAVINGS CARD

Not an actual savings card.

Free Trial Offer for Eligible Patients†Savings Coupon for Eligible Privately Insured Patients‡




Frequently Asked Questions (FAQs)

Here are a few of the most commonly asked questions when it comes to insomnia and BELSOMRA.

Is BELSOMRA FDA approved?

How is BELSOMRA different?

How likely am I to feel drowsy the next morning?

Yes. BELSOMRA is an FDA-approved prescription medicine for adults who have trouble falling asleep and/or staying asleep (insomnia).

BELSOMRA specifically targets the action of orexin, a neurotransmitter that signals your brain to be awake. BELSOMRA quiets the action of orexin from sending wake signals to other parts of the brain. This is how BELSOMRA is thought to help you fall and stay asleep.

In clinical trials, 7% of patients taking BELSOMRA 15 mg or 20 mg reported somnolence (next-day drowsiness) compared to 3% of patients taking placebo. You may still feel drowsy the next day after taking BELSOMRA. Do not drive or do other dangerous activities until you feel fully awake.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Q

Q

Q

A

A

A

Below is a list of the most commonly reported adverse events that occurred in 3-month clinical trials:

What are the possible side effects of BELSOMRA?

BELSOMRA has possible side effects. Before you begin treatment, it’s important to know what these side effects are and to discuss the risks and benefits of taking BELSOMRA with your doctor.

BELSOMRA may cause serious side effects that you may not know are happening to you. These side effects include:

sleepiness during the day

not thinking clearly

acting strangely, confused, or upset

“sleep-walking” or doing other activities when you are asleep like eating, talking, having sex, or driving a car.

Call your doctor right away if you find out that you have done any of the above activities after taking BELSOMRA.

Q

A

Is it best to take BELSOMRA with or without food?

When do I take BELSOMRA?

BELSOMRA may be taken with or without a meal. However, BELSOMRA may take longer to work if you take it with or right after meals.

You should take BELSOMRA 1 time each night, if needed, within 30 minutes of going to bed and only when you can get a full night’s sleep (at least 7 hours).

Q

Q

A

A

placebo (n=767) BELSOMRA 15 mg or 20 mg (n=493)

Diarrhea . . . . . . . . . . . . . (placebo 1%, BELSOMRA 2%)

Dry mouth . . . . . . . . . . . (placebo 1%, BELSOMRA 2%)

Upper respiratory tract infection . . . . . . . . (placebo 1%, BELSOMRA 2%)

Headache . . . . . . . . . . . . (placebo 6%, BELSOMRA 7%)

Next-day drowsiness . . (placebo 3%, BELSOMRA 7%)

Dizziness . . . . . . . . . . . . (placebo 2%, BELSOMRA 3%)

Abnormal dreams . . . . . (placebo 1%, BELSOMRA 2%)

Cough . . . . . . . . . . . . . . . (placebo 1%, BELSOMRA 2%)

About BELSOMRA® (suvorexant)





Frequently Asked Questions (FAQs) (continued)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

What is the right dose for me?

Because medicines work differently for different people, BELSOMRA is available in multiple strengths. The recommended dose is 10 mg.*

Only you know when you’re getting the sleep you need, so tell your doctor if you’re still not sleeping well with 10 mg.* If that happens, your doctor may suggest that you increase your dose to 15 mg or 20 mg if the 10-mg* dose is well tolerated. Always work with your doctor to find the dose that’s right for you. Do not take more than 20 mg of BELSOMRA in 1 day.

Contact your doctor if your insomnia worsens or is not better within 7 to 10 days, as another condition may be causing your sleep problem.

Also talk to your doctor if you are switching from another sleep medicine, as this may impact your ability to understand how BELSOMRA is working for you, and discuss the best way to discontinue your old medication and start BELSOMRA.

*5 mg is the recommended dose for certain patients, and these patients should generally not exceed 10 mg.

Q

A What happens when patients stop taking BELSOMRA?

In clinical trials, there was no evidence of physical dependence with the prolonged use of BELSOMRA. There were no reported withdrawal symptoms after discontinuation.

BELSOMRA is a federally controlled substance because it can be abused or cause dependence. Keep BELSOMRA in a safe place to prevent misuse and abuse. Selling or giving away BELSOMRA may harm others and is against the law. Tell your doctor if you have ever abused or have been dependent on alcohol, prescription medicines, or street drugs.

Q

A

Does insurance cover BELSOMRA?

Your insurance plan may cover BELSOMRA. However, the plan may require that you first try another medication, such as a generic medication. If this happens, talk to your health care professional. He/she may have to fill out a prior authorization form to help you with your insurance coverage for BELSOMRA. Be prepared with information your health care professional may need to provide to the insurance company, including your prescription medication history.

Q

A

What to Expect With BELSOMRA® (suvorexant)

What should I expect when starting BELSOMRAwith my recommended dose?

The way you feel when you fall asleep with BELSOMRA may be different from what you have experienced in the past or what you expected. Therefore, it is important to give BELSOMRA an adequate trial period. Try BELSOMRA for a few nights to a week to see how it works for you.

Q

A

If you are struggling to fall asleep or stay asleep, ask your doctor about BELSOMRA.







It is not known if BELSOMRA is safe and effective in children under the age of 18 years.




BELSOMRA may cause serious side effects that you may not know are happening to you. These side effects include:

• sleepiness during the day

• not thinking clearly

• acting strangely, confused, or upset

• “sleep-walking” or doing other activities when you are asleep like eating, talking, having sex, or driving a car.

• Call your doctor right away if you find out that you have done any of these activities after taking BELSOMRA.

Do not take BELSOMRA if you fall asleep often at unexpected times (narcolepsy).

BELSOMRA is a controlled substance because it can be abused or cause dependence.

Before taking BELSOMRA, tell your doctor about all of your medical conditions, including if you:

• have a history of depression, mental illness, or suicidal thoughts

• have a history of drug or alcohol abuse or addiction

• have a history of a sudden onset of muscle weakness (cataplexy)

• have a history of falling asleep often at unexpected times (narcolepsy) or daytime sleepiness

• have lung or breathing problems

• have liver problems

• are pregnant or plan to become pregnant

• are breastfeeding or plan to breastfeed.

Medicines can interact with each other, sometimes causing serious side effects. Do not take BELSOMRA with other medicines that can make you sleepy unless your doctor tells you to.

Call your doctor if your insomnia (sleep problem) worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

Do not drink alcohol while taking BELSOMRA. It can increase your chances of getting serious side effects.

Do not drive, operate heavy machinery, do anything dangerous, or do other activities that require clear thinking after taking BELSOMRA.

You may still feel drowsy the next day after taking BELSOMRA. Do not drive or do other dangerous activities until you feel fully awake.

BELSOMRA may cause serious side effects, including:

• abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions

• memory loss

• anxiety

• temporary inability to move or talk (sleep paralysis) for up to several minutes while you are going to sleep or waking up

• temporary weakness in your legs that can happen during the day or at night.

The most common side effects of BELSOMRA include drowsiness the next day after you take BELSOMRA.

What Is BELSOMRA® (suvorexant)?

Start off right—register for personalized support and resources at BelsomraBeginnings.com




Questions about BELSOMRA?

Call 844-BELSOMRA for more information.

Copyright © 2017 Merck Sharp & Dohme Corp.,

a subsidiary of Merck & Co., Inc. All rights reserved.

NEUR-1114666-0017 10/17

BELSOMRA® (suvorexant)







In clinical studies, BELSOMRA demonstrated that patients fell asleep faster and stayed asleep longer when compared to patients taking placebo.

The way you feel when you fall asleep may be different from what you have experienced in the past. It’s important to give BELSOMRA an adequate trial period of a few nights to a week, to see how it works for you.

BELSOMRA comes in multiple strengths, so if you’re not sleeping well and your dose is well tolerated, your doctor may suggest increasing your dose to find the strength that is right for you.

Practicing good sleep habits is important and is recommended when taking BELSOMRA.

BELSOMRA is FDA approved for adults who have trouble falling asleep and staying asleep (insomnia).

are you looking for a different option to treat your insomnia?

Documents