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.
