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

Transcription

1 re you looking for a different option to treat your insomnia? BELSOMR is a prescription medicine for adults who have trouble falling or staying asleep (insomnia). Selected Risk Information Do not take more BELSOMR than prescribed. Do not take BELSOMR unless you are able to stay in bed a full night (at least 7 hours) before you must be active again. Provided as an educational resource by Merck.

2 BELSOMR is a prescription medicine for adults who have trouble falling or staying asleep (insomnia). It is not known if BELSOMR is safe and effective in children under the age of 18 years. Table of Contents Sleep & Wake Pathways... 3 BELSOMR Works Differently... 4 Clinical Study Results for BELSOMR... 4 What to Expect When Starting BELSOMR With Your Recommended Dose Finding the Right Dose... 5 re Your Sleep Habits Really Wake Habits... 6 Get nswers to uestions on Sleep... 7 Special Offers... 8 Frequently sked uestions (Fs) Selected Risk Information Summary Selected Risk Information Do not take more BELSOMR than prescribed. Do not take BELSOMR unless you are able to stay in bed a full night (at least 7 hours) before you must be active again. Take BELSOMR within 30 minutes of going to bed. 2

3 Sleep and Wake Pathways Under Regular Conditions 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. Insomnia: Could There Be a Problem With Your Wake Pathway? 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. Talk to your doctor about what may be causing your insomnia. Selected Risk Information (continued) BELSOMR 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 BELSOMR. Do not take BELSOMR if you fall asleep often at unexpected times (narcolepsy). BELSOMR is a controlled substance because it can be abused or cause dependence. 3

4 BELSOMR (suvorexant) Works Differently Clinical Study Results for BELSOMR wake Mode BELSOMR is FD approved for adults who have trouble falling asleep (sleep onset) and staying asleep (sleep maintenance). In clinical studies, BELSOMR demonstrated that: Orexin Neurons BELSOMR targets and inhibits the action of orexin. People fell asleep faster and stayed asleep longer when using BELSOMR compared to patients taking placebo. There was no evidence of physical dependence after prolonged use of BELSOMR. There were no reported withdrawal symptoms after discontinuation. BELSOMR works differently from other sleep medications. By targeting the action of orexin, a neurotransmitter that signals your brain to be awake, BELSOMR quiets the action of orexin from sending wake signals to other parts of the brain. This is how BELSOMR is thought to help you fall and stay asleep. BELSOMR is a federally controlled substance because it can be abused or cause dependence. Keep BELSOMR in a safe place to prevent misuse and abuse. Selling or giving away BELSOMR 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. Selected Risk Information (continued) Before taking BELSOMR, 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. sk your doctor whether BELSOMR can help you drift off to sleep and stay asleep. Talk to your doctor about BELSOMR, a sleep aid that works differently. 4

5 What to Expect When Starting BELSOMR (suvorexant) With Your Recommended Dose The way you feel when you fall asleep with BELSOMR may be different from what you have experienced in the past or what you expected. Therefore, it is important to give BELSOMR an adequate trial period. Try BELSOMR 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. Selected Risk Information (continued) Medicines can interact with each other, sometimes causing serious side effects. Do not take BELSOMR with other medicines that can make you sleepy unless your doctor tells you to. Do not drink alcohol while taking BELSOMR. 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 BELSOMR. Finding the Right Dose Your insomnia is as individual as you are, and medicines work differently for different people, so BELSOMR 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 BELSOMR in 1 day. You may still feel drowsy the next day after taking BELSOMR. Do not drive or do other dangerous activities until you feel fully awake. How should I take BELSOMR? Take BELSOMR exactly as your doctor tells you to take it. Only take BELSOMR 1 time each night, if needed, within 30 minutes of going to bed. Only take BELSOMR when you can get a full night s sleep (at least 7 hours). Do not take BELSOMR if you drank alcohol that evening or before bed. BELSOMR may be taken with or without a meal. However, BELSOMR 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 BELSOMR, call your doctor right away or get emergency treatment. The recommended dose is 10 mg.* Not actual size shown. For illustration purposes only. *5 mg is the recommended dose for certain patients, and these patients should generally not exceed 10 mg. 5

6 re Your Sleep Habits Really Wake Habits? re 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. dopt 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 BELSOMR 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 BELSOMR. fter 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. 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. Start off right register for personalized support and resources at BelsomraBeginnings.com For Selected Risk Information, please see page 11. 6

7 Get nswers to uestions 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 hours of sleep do you get when you have trouble sleeping (total sleep time)? How many nights per week do you have trouble sleeping? HOURS NIGHTS Selected Risk Information (continued) BELSOMR 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 BELSOMR include drowsiness the next day after you take BELSOMR. Do you have trouble falling asleep? YES NO Do you have trouble staying asleep? YES NO Do you consistently wake up much earlier than you want to? YES NO Fill out this checklist, then talk to your doctor about your specific symptoms What parts of your life are impacted by your lack of sleep? 7

8 Special Offers for BELSOMR (suvorexant) Free Trial Offer for Eligible Patients If you and your doctor agree BELSOMR is right for you, you may be eligible to receive a free 10-day trial supply of BELSOMR. Eligible patients can view and print a Free Trial Offer for BELSOMR 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. Savings Coupon for Eligible Privately Insured Patients Eligible privately insured patients may save on their prescriptions for BELSOMR. Eligible patients can review the Terms and Conditions, and view and print the Savings Coupon for BELSOMR, 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. MULTI-USE SVINGS CRD Not an actual savings card. Sign Up for Support Register at belsomra.com to get support and additional information about BELSOMR. Talk to your doctor or visit belsomra.com for details. For Selected Risk Information, please see page

9 Frequently sked uestions (Fs) Here are a few of the most commonly asked questions when it comes to insomnia and BELSOMR. bout BELSOMR (suvorexant) Is BELSOMR FD approved? What are the possible side effects of BELSOMR? Yes. BELSOMR is an FD-approved prescription medicine for adults who have trouble falling asleep and/or staying asleep (insomnia) How is BELSOMR different? BELSOMR specifically targets the action of orexin, a neurotransmitter that signals your brain to be awake. BELSOMR quiets the action of orexin from sending wake signals to other parts of the brain. This is how BELSOMR is thought to help you fall and stay asleep When do I take BELSOMR? BELSOMR 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 BELSOMR with your doctor. BELSOMR 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 BELSOMR. You should take BELSOMR 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) Below is a list of the most commonly reported adverse events that occurred in 3-month clinical trials: placebo (n=767) BELSOMR 15 mg or 20 mg (n=493) Diarrhea...(placebo 1%, BELSOMR 2%) Is it best to take BELSOMR with or without food? BELSOMR may be taken with or without a meal. However, BELSOMR may take longer to work if you take it with or right after meals. Dry mouth...(placebo 1%, BELSOMR 2%) Upper respiratory tract infection...(placebo 1%, BELSOMR 2%) Headache...(placebo 6%, BELSOMR 7%) Next-day drowsiness..(placebo 3%, BELSOMR 7%) Dizziness...(placebo 2%, BELSOMR 3%) bnormal dreams...(placebo 1%, BELSOMR 2%) How likely am I to feel drowsy the next morning? Cough...(placebo 1%, BELSOMR 2%) In clinical trials, 7% of patients taking BELSOMR 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 BELSOMR. Do not drive or do other dangerous activities until you feel fully awake. For Selected Risk Information, please see page 11. 9

10 Frequently sked uestions (Fs) (continued) What to Expect With BELSOMR (suvorexant) What should I expect when starting BELSOMR with my recommended dose? The way you feel when you fall asleep with BELSOMR may be different from what you have experienced in the past or what you expected. Therefore, it is important to give BELSOMR an adequate trial period. Try BELSOMR for a few nights to a week to see how it works for you What is the right dose for me? Because medicines work differently for different people, BELSOMR 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. lways work with your doctor to find the dose that s right for you. Do not take more than 20 mg of BELSOMR 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. lso talk to your doctor if you are switching from another sleep medicine, as this may impact your ability to understand how BELSOMR is working for you, and discuss the best way to discontinue your old medication and start BELSOMR. *5 mg is the recommended dose for certain patients, and these patients should generally not exceed 10 mg. If you are struggling to fall asleep or stay asleep, ask your doctor about BELSOMR. What happens when patients stop taking BELSOMR? In clinical trials, there was no evidence of physical dependence with the prolonged use of BELSOMR. There were no reported withdrawal symptoms after discontinuation. BELSOMR is a federally controlled substance because it can be abused or cause dependence. Keep BELSOMR in a safe place to prevent misuse and abuse. Selling or giving away BELSOMR 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 Does insurance cover BELSOMR? Your insurance plan may cover BELSOMR. 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 BELSOMR. Be prepared with information your health care professional may need to provide to the insurance company, including your prescription medication history. For Selected Risk Information, please see page

11 What Is BELSOMR (suvorexant)? BELSOMR is a prescription medicine for adults who have trouble falling or staying asleep (insomnia). It is not known if BELSOMR is safe and effective in children under the age of 18 years. Selected Risk Information Do not take more BELSOMR than prescribed. 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 BELSOMR with other medicines that can make you sleepy unless your doctor tells you to. Do not take BELSOMR unless you are able to stay in bed a full night (at least 7 hours) before you must be active again. Take BELSOMR within 30 minutes of going to bed. BELSOMR 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 BELSOMR. Do not take BELSOMR if you fall asleep often at unexpected times (narcolepsy). BELSOMR is a controlled substance because it can be abused or cause dependence. Before taking BELSOMR, 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) 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 BELSOMR. 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 BELSOMR. You may still feel drowsy the next day after taking BELSOMR. Do not drive or do other dangerous activities until you feel fully awake. BELSOMR 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 BELSOMR include drowsiness the next day after you take BELSOMR. have a history of falling asleep often at unexpected times (narcolepsy) or daytime sleepiness 11

12 BELSOMR is a prescription medicine for adults who have trouble falling or staying asleep (insomnia). BELSOMR (suvorexant) In clinical studies, BELSOMR 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 BELSOMR an adequate trial period of a few nights to a week, to see how it works for you. BELSOMR 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 BELSOMR. BELSOMR is FD approved for adults who have trouble falling asleep and staying asleep (insomnia). Selected Risk Information Do not take more BELSOMR than prescribed. Do not take BELSOMR unless you are able to stay in bed a full night (at least 7 hours) before you must be active again. Take BELSOMR within 30 minutes of going to bed. uestions about BELSOMR? Call 844-BELSOMR for more information. Start off right register for personalized support and resources at BelsomraBeginnings.com 12 Copyright 2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. ll rights reserved. NEUR /17