• Quviviq is a prescription medicine for adults who have trouble falling asleep or staying asleep (insomnia).
• It is not known if this medicine is safe and effective for use in children.

Quviviq is a federally controlled substance (CIV) because it can be abused or lead to dependence.

Keep Quviviq in a safe place to prevent misuse and abuse. Selling or giving away Quviviq may harm others and is against the law.

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.
  • Do not take more Quviviq than prescribed.
  • Do not take Quviviq unless you are able to stay in bed for a full night (at least 7 hours) before you must be active again.
  • Take Quviviq in the evening within 30 minutes before going to bed.

See Quviviq side effects for more information about side effects.

• Take Quviviq exactly as your healthcare provider tells you to take it.
• Do not change your dose without first talking to your healthcare provider.
• Take Quviviq one time each night, within 30 minutes before going to bed.
• Only take Quviviq when you can stay in bed for a full night (at least 7 hours).
• Quviviq may take longer to work if you take it with or right after a meal.
• Call your healthcare provider if your insomnia (sleep problem) worsens or is not improved within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
• If you take too much or overdose, call your healthcare provider or go to the nearest hospital emergency room right away.

Usual Adult Dose for Insomnia

25 mg to 50 mg once per night

Comments:
-take orally within 30 minutes before going to bed, with at least 7 hours remaining prior to planned awakening.
-time to sleep onset may be delayed if taken with or soon after a meal.

Use: treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

Do not take Quviviq if you fall asleep often at unexpected times (narcolepsy).

Before taking Quviviq

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
• 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 daytime sleepiness
• have lung or breathing problems, including sleep apnea
• have liver problems
• are pregnant or plan to become pregnant. It is not known if Quviviq can harm your unborn baby.
  • Pregnancy Registry: There is a pregnancy registry for women who are exposed to Quviviq during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. For more information or to participate in the registry, call 1-833-400-9611. Talk with your healthcare provider about the risk to your unborn baby if you take Quviviq during pregnancy.
• are breastfeeding or plan to breastfeed. It is not known if Quviviq passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.

• Do not drink alcohol while taking Quviviq. It can increase the effects of alcohol, which can be dangerous.
• You may still feel drowsy the next day after taking Quviviq.
  • Do not drive, operate heavy machinery, do anything dangerous, or do other activities that require clear thinking if you have taken Quviviq as prescribed but do not feel fully awake, 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 by your healthcare provider.

Quviviq may cause serious side effects, including:

• See Important information.
• 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.
• 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. Stop taking Quviviq and call your healthcare provider right away if you experience a complex sleep behavior.

The most common side effects include headache and sleepiness.

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 your healthcare provider tells you to.

Other drugs may affect Quviviq, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.