BELSOMRA® (suvorexant) 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 years.
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.
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
- 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 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 other dangerous activities, 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
- 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® (suvorexant) include drowsiness the next
day after you take BELSOMRA.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please read the accompanying Medication Guide for BELSOMRA and discuss it
with your doctor. The physician Prescribing Information also is available.