Sunday, May 26, 2019 5:47:39 PM
Bold is mine.. I wouldn't take it.
Selected Risk Information
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 years.
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 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
https://www.belsomra.com/static/pdf/belsomra-patient-education-brochure.pdf
Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of BELSOMRA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiac disorders: palpitations, tachycardia
Nervous system disorders: psychomotor hyperactivity
Psychiatric disorders: anxiety
https://www.rxlist.com/belsomra-side-effects-drug-center.htm#professional
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