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Full Prescribing Information

Medication Guide

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QUVIVIQ

QUVIVIQ is a prescription treatment for adults who have trouble falling asleep or staying asleep (insomnia).

What is Lorem Ipsum?

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Why do we use it?

It is a long established fact that a reader will be distracted by the readable content of a page when looking at its layout. The point of using Lorem Ipsum is that it has a more-or-less normal distribution of letters, as opposed to using ‘Content here, content here’, making it look like readable English. Many desktop publishing packages and web page editors now use Lorem Ipsum as their default model text, and a search for ‘lorem ipsum’ will uncover many web sites still in their infancy. Various versions have evolved over the years, sometimes by accident, sometimes on purpose (injected humour and the like).

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Contrary to popular belief, Lorem Ipsum is not simply random text. It has roots in a piece of classical Latin literature from 45 BC, making it over 2000 years old. Richard McClintock, a Latin professor at Hampden-Sydney College in Virginia, looked up one of the more obscure Latin words, consectetur, from a Lorem Ipsum passage, and going through the cites of the word in classical literature, discovered the undoubtable source. Lorem Ipsum comes from sections 1.10.32 and 1.10.33 of “de Finibus Bonorum et Malorum” (The Extremes of Good and Evil) by Cicero, written in 45 BC. This book is a treatise on the theory of ethics, very popular during the Renaissance. The first line of Lorem Ipsum, “Lorem ipsum dolor sit amet..”, comes from a line in section 1.10.32.

The standard chunk of Lorem Ipsum used since the 1500s is reproduced below for those interested. Sections 1.10.32 and 1.10.33 from “de Finibus Bonorum et Malorum” by Cicero are also reproduced in their exact original form, accompanied by English versions from the 1914 translation by H. Rackham.

Where can I get some?

There are many variations of passages of Lorem Ipsum available, but the majority have suffered alteration in some form, by injected humour, or randomised words which don’t look even slightly believable. If you are going to use a passage of Lorem Ipsum, you need to be sure there isn’t anything embarrassing hidden in the middle of text. All the Lorem Ipsum generators on the Internet tend to repeat predefined chunks as necessary, making this the first true generator on the Internet. It uses a dictionary of over 200 Latin words, combined with a handful of model sentence structures, to generate Lorem Ipsum which looks reasonable. The generated Lorem Ipsum is therefore always free from repetition, injected humour, or non-characteristic words etc.

What is QUVIVIQ (daridorexant)?

QUVIVIQ is a prescription medicine for adults who have trouble falling asleep or staying asleep (insomnia).

Important Safety Information

Do not take QUVIVIQ if you fall asleep often at unexpected times (narcolepsy) or if you are allergic to QUVIVIQ or any of its ingredients.

QUVIVIQ may cause serious side effects, including:

  • Decreased awareness and alertness. The morning after you take QUVIVIQ, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day.

What is QUVIVIQ (daridorexant)?

QUVIVIQ is a prescription medicine for adults who have trouble falling asleep or staying asleep (insomnia).

 

Important Safety Information

Do not take QUVIVIQ if you fall asleep often at unexpected times (narcolepsy) or if you are allergic to QUVIVIQ or any of its ingredients.

 

QUVIVIQ may cause serious side effects, including:

  • Decreased awareness and alertness. The morning after you take QUVIVIQ, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day. Sleepiness may increase your risk of falls.
  • Do not take more QUVIVIQ than prescribed.
  • Do not take QUVIVIQ unless you are able to stay in bed for at least 7 hours before you must be active again.
  • Take QUVIVIQ at night within 30 minutes before going to bed.

 

QUVIVIQ is a federally controlled substance because it can be abused or lead to dependence.

 

Before taking QUVIVIQ, tell your healthcare provider about all of your medical conditions, including if you:

  • have a history of depression, mental illness, or suicidal thoughts or actions; drug or alcohol abuse or addiction; a sudden onset of muscle weakness (cataplexy); daytime sleepiness
  • have lung or breathing problems, including sleep apnea
  • have liver problems
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

 

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

  • Taking QUVIVIQ with certain medicines can cause serious side effects. QUVIVIQ may affect the way other medicines work and other medicines may affect the way QUVIVIQ works.
  • Do not take QUVIVIQ with other medicines that can make you sleepy unless instructed by your healthcare provider.

 

What should I avoid while taking QUVIVIQ?

  • Do not drink alcohol while taking QUVIVIQ. It can increase the effects of alcohol, which can be dangerous.
  • Do not drive, operate heavy machinery, do anything dangerous, or do other activities that require clear thinking if you do not feel fully awake, or you have taken QUVIVIQ and have less than a full night of sleep (at least 7 hours), or if you have taken more QUVIVIQ than prescribed.

 

QUVIVIQ may cause other serious side effects, including:

  • Worsening depression and suicidal thoughts. Call your healthcare provider right away if you have any worsening depression or thoughts of suicide or dying.
  • Temporary inability to move or talk (sleep paralysis) for up to several minutes, or hallucinations while you are going to sleep or waking up.
  • Temporary weakness in your legs that can happen during the day or at night.
  • Complex sleep behaviors such as sleepwalking, 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. Stop taking QUVIVIQ and call your healthcare provider right away if you experience a complex sleep behavior.

 

The most common side effects of QUVIVIQ are headache and sleepiness or tiredness.

 

These are not the only side effects of QUVIVIQ. Call your doctor for 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.

 

Please see full Prescribing Information and Medication Guide.