Selected Risk Information

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.

  • 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, including:

  • worsening depression or suicidal thoughts and actions. Call your doctor right away if you have any worsening depression or thoughts of suicide or dying.
  • complex sleep behaviors, including sleep-walking, sleep-driving or other activities while not fully awake. Call your doctor right away if you experience a complex sleep behavior.
  • 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.

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.

The most common side effect of BELSOMRA is sleepiness 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.

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 or call 1-800-FDA-1088.