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 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.
•   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.
•   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 treatment.