Possible side effects

What are the possible side effects of BELSOMRA?

BELSOMRA may cause serious side effects, including:

  • 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.
  • Worsening depression and suicidal thoughts have happened during treatment with BELSOMRA. Call your healthcare provider right away if you have any worsening depression or thoughts of suicide or dying.
  • Complex sleep behaviors such as sleep-walking, sleep-driving, preparing and eating food, making phone calls, having sex or doing other activities while not fully awake that you may not remember the next morning. Call your healthcare provider 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.

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)

  • Diarrhea (placebo 1%, BELSOMRA 2%)
  • Dry mouth (placebo 1%, BELSOMRA 2%)
  • Upper respiratory tract infection (placebo 1%, BELSOMRA 2%)
  • Headache (placebo 6%, BELSOMRA 7%)
  • Next-day drowsiness (placebo 3%, BELSOMRA 7%)
  • Dizziness (placebo 2%, BELSOMRA 3%)
  • Abnormal dreams (placebo 1%, BELSOMRA 2%)
  • Cough (placebo 1%, BELSOMRA 2%)

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.

Do not drive or do other dangerous activities until you feel fully awake.

To learn more, review Selected Risk Information.

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.

Tell your doctor if you have ever abused or have been dependent on alcohol, prescription medicines, or street drugs.


Help your doctor understand your insomnia.

Do you have trouble falling asleep?
Do you have trouble staying asleep?

Talk to your doctor

Explore related topics

How to take BELSOMRA

How to take BELSOMRA

What is BELSOMRA?

What is BELSOMRA?

What is insomnia?

What is insomnia?

About BELSOMRA

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.

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 www.fda.gov/medwatch or call 1-800-FDA-1088.

About BELSOMRA (suvorexant) C-IV

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.

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.

Selected Risk Information for BELSOMRA (suvorexant) C-IV

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 www.fda.gov/medwatch or call 1-800-FDA-1088.

BELSOMRA may cause decreased awareness and alertness. The morning after you take BELSOMRA, your ability to drive safely and think

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.