BELSOMRA® (bell-SOM-rah)
Tablets C-IV
What is the most important information I should know about BELSOMRA?
• 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.
• Take BELSOMRA within 30 minutes of going to bed.
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
act 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.
• BELSOMRA is a prescription medicine for adults who have trouble falling or staying
asleep (insomnia).
• It is not known if BELSOMRA is safe and effective in children under the age of 18.
BELSOMRA is a federally controlled substance (C-IV) 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
Who should not take BELSOMRA?
Do not take BELSOMRA if you fall asleep often at unexpected times (narcolepsy).
What should I tell my doctor before taking BELSOMRA?
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
• have lung problems or breathing problems
• have liver problems
• are pregnant or plan to become pregnant. It is not known if BELSOMRA can harm your
unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if BELSOMRA passes into your
breast milk.
Tell your doctor about all the medicines you take, including prescription or over-thecounter medicines, vitamins, or herbal supplements. 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.
Know the medicines you take. Keep a list of your medicines with you to show your doctor
and pharmacist each time you get a new medicine.
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
What should I avoid while taking BELSOMRA?
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.
What are the possible side effects of BELSOMRA?
BELSOMRA may cause serious side effects including:
• See “What is the most important information I should know about
• 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
These are not all the possible side effects of BELSOMRA. For more information, ask your
doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA
at 1-800-FDA-1088.
How should I store BELSOMRA?
• Store BELSOMRA at room temperature between 68°F to 77°F (20°C to 25°C).
• Store in the original package until use, to protect from light and moisture.
• Keep BELSOMRA and all medicines out of reach of children.
General information about the safe and effective use of BELSOMRA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication
Guide. Do not use BELSOMRA for a condition for which it was not prescribed. Do not give
BELSOMRA to other people, even if they have the same symptoms that you have. It may
harm them.
This Medication Guide summarizes the most important information about BELSOMRA. You
can ask your pharmacist or doctor for information about BELSOMRA that is written for
health professionals.
For more information, go to www.BELSOMRA.com or call 1-800-622-4477.
What are the ingredients in BELSOMRA?
Active ingredient: Suvorexant
Inactive ingredients: Polyvinylpyrrolidone/vinyl acetate copolymer (copovidone),
microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium
stearate. The film coating contains: lactose monohydrate, hypromellose, titanium dioxide,
and triacetin. The film coating for the 5 mg tablets also contains iron oxide yellow and iron
oxide black, and the film coating for the 10 mg tablets also contains iron oxide yellow and
FD&C Blue #1/Brilliant Blue FCF Aluminum Lake.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
For patent information: www.merck.com/product/patent/home.html
Copyright © 2014 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.
Issued: 08/2014