BELSOMRA is a prescription medicine for adults who have trouble falling or staying asleep (insomnia).
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.
What are the possible side effects of BELSOMRA?
BELSOMRA may cause serious side effects, including:
BELSOMRA may cause serious side effects, including:
The most common side effects of BELSOMRA include drowsiness the next day after you take BELSOMRA.
The following additional side effects have been reported with BELSOMRA: abnormal dreams.
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 are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Below is a list of the most commonly reported adverse events that occurred in 3-month clinical trials:
placebo (n=767) BELSOMRA 15 mg or 20 mg (n=493)
How likely am I to feel drowsy the next morning?
The most common side effects of BELSOMRA include drowsiness the next day after you take BELSOMRA. 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.
What happens when I 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.
Help your doctor understand your insomnia.
Do I have trouble falling asleep?
Do I have trouble staying asleep?
BELSOMRA may cause decreased awareness and alertness. The morning after you take BELSOMRA, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day.
BELSOMRA may cause serious side effects, including:
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:
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.
The most common side effect of BELSOMRA is sleepiness the next day after you take BELSOMRA.
How Should I Take BELSOMRA?
Please read the accompanying Medication Guide for BELSOMRA and discuss it with your doctor. The physician Prescribing Information also is available.
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.
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