Quviviq

Insomnia Treatment

Quviviq is used to treat insomnia in adults. Insomnia is a sleep disorder characterized by persistent problems with sleep quality or duration despite having adequate opportunity for rest.

This medication is specifically approved to help with two main types of sleep difficulties:

• Sleep onset: This refers to the struggle to fall asleep at the start of the night.
• Sleep maintenance: This refers to the struggle to stay asleep throughout the night or waking up too early.

Quviviq works differently than many traditional sleep medications. It is classified as a dual orexin receptor antagonist (DORA). Instead of broadly sedating the brain, it targets and blocks orexin, a naturally occurring chemical that signals the brain to stay awake and alert. By dampening this wakefulness signal, the medication helps transition the body into sleep.

It is intended for use only when an individual can dedicate at least seven hours to sleep before needing to be active again.

Mechanism of Action

Quviviq belongs to a class of medications called dual orexin receptor antagonists (DORAs). It works differently than many traditional sleep medications that act as general sedatives.

The brain naturally produces a chemical called orexin. This chemical is responsible for signaling the brain to stay awake, alert, and vigilant. For many people with insomnia, these wake-promoting signals may remain active when they should be winding down for the night.

Quviviq helps manage insomnia by:

• Binding to orexin receptors in the brain.
• Blocking the wake-promoting signals sent by orexin.
• Reducing the brain's drive to stay awake, which allows sleep to occur.

By specifically targeting the wakefulness system rather than just sedating the entire central nervous system, the medication helps patients fall asleep more quickly and stay asleep throughout the night.

Common Side Effects

The most frequently reported side effects of Quviviq include:

• Headache
• Somnolence (sleepiness or grogginess)
• Dizziness
• Fatigue
• Nausea

Serious Side Effects

While less common, Quviviq can cause serious side effects. Seek medical attention if you experience:

• Complex sleep behaviors: Engaging in activities such as sleepwalking, driving a car, preparing and eating food, or making phone calls while not fully awake. You may not remember these events the next morning.
• Sleep paralysis: A temporary inability to move or talk for up to several minutes while falling asleep or waking up.
• Hallucinations: Seeing or hearing things that are not real when falling asleep or waking up.
• Mental health changes: New or worsening depression, anxiety, or suicidal thoughts and actions.
• Daytime impairment: Extreme drowsiness that makes it unsafe to drive or perform tasks requiring full alertness.
• Leg weakness: Sudden muscle weakness in the legs that can occur during the day or night.

Central Nervous System Depression and Daytime Impairment

Quviviq is a central nervous system (CNS) depressant that may impair alertness and motor coordination the day after use. This risk is higher if the medication is taken without allowing for a full night of sleep (at least 7 hours) or if it is combined with alcohol or other CNS depressants. Even if an individual feels fully awake, their ability to drive or perform tasks requiring mental alertness may be compromised.

Complex Sleep Behaviors

Taking Quviviq may lead to complex sleep behaviors, which involve performing activities while not fully awake. These incidents can result in serious injury or death. Reported behaviors include:

• Sleep-walking
• Sleep-driving (driving while not fully awake)
• Preparing and eating food
• Making phone calls
• Having sex

Healthcare providers typically recommend discontinuing the medication immediately if any of these behaviors occur.

Worsening of Depression and Suicidal Ideation

In patients with pre-existing depression, the use of sleep medications may lead to a worsening of symptoms or the development of suicidal thoughts and actions. Monitoring for changes in mood, behavior, or thinking is standard practice during treatment.

Sleep Paralysis and Hallucinations

Quviviq can cause symptoms similar to those seen in narcolepsy. These include sleep paralysis, which is the temporary inability to move or speak for several minutes while falling asleep or waking up, and vivid hallucinations. Cataplexy-like symptoms, such as sudden muscle weakness, have also been reported.

Contraindications and Respiratory Considerations

Quviviq is contraindicated in patients with narcolepsy. Additionally, caution is advised for individuals with compromised respiratory function, such as those with obstructive sleep apnea (OSA) or chronic obstructive pulmonary disease (COPD). The medication is not recommended for use in patients with severe hepatic impairment.

Pregnancy

It is not currently known if Quviviq will harm an unborn baby, as there are no adequate studies in pregnant humans. In animal studies, the medication did not show evidence of harm to the fetus even at doses significantly higher than those used in humans. If you are pregnant or planning to become pregnant, you should discuss the potential risks and benefits with your healthcare provider before using this medication.

A pregnancy registry is available for individuals who take Quviviq during pregnancy. This registry collects data to help healthcare providers better understand the safety of the drug for both the parent and the baby.

Breastfeeding

It is unknown if Quviviq passes into human breast milk or if it could affect a nursing infant. Because many medications are excreted in breast milk, it is important to consult with a healthcare professional about the risks of breastfeeding while taking this drug. If you use Quviviq while breastfeeding, you should monitor the infant for signs of excessive sleepiness or drowsiness.

Dosage Forms

Quviviq is supplied as a film-coated tablet intended for oral administration.

The medication is available in different strengths to allow for individualized treatment. A healthcare provider will determine the appropriate strength based on factors such as the patient's medical condition, age, and whether they are taking other medications that may interact with Quviviq.

FDA Approval and Indication

The U.S. Food and Drug Administration (FDA) approved Quviviq in January 2022. It is indicated for the treatment of adults with insomnia who have difficulty falling asleep, staying asleep, or both.

Controlled Substance Status

Quviviq is classified as a Schedule IV controlled substance under the Controlled Substances Act. This designation means the medication has a potential for abuse or dependence, though it is considered to have a lower risk compared to Schedule III substances. Because of this status, there are specific federal and state regulations regarding how the medication is prescribed and refilled.

Safety and Regulatory Monitoring

The FDA evaluated the safety and effectiveness of Quviviq based on clinical trials involving adults with insomnia. While the medication does not have a boxed warning, the FDA-approved labeling includes several important safety warnings:

• Complex Sleep Behaviors: The FDA requires warnings regarding the risk of engaging in activities while not fully awake, such as sleep-walking, sleep-driving, or preparing food, often with no memory of the event.
• CNS Depressant Effects: There is a risk of impaired mental alertness and motor coordination the morning after use, which can affect activities like driving.
• Worsening of Depression: Regulatory labeling includes precautions for patients with pre-existing depression, as sleep medications may be associated with a worsening of symptoms or suicidal thoughts.

Factors Influencing Cost

Several factors determine the out-of-pocket price for Quviviq:

• Insurance Coverage: Many private insurance plans and some Medicare Part D plans cover Quviviq, but the copay amount depends on your specific plan's formulary. Some insurers may require prior authorization, meaning your doctor must provide additional information to the insurance company before the drug is covered.
• Pharmacy Choice: Prices can differ between retail pharmacies and mail-order services. It is often helpful to compare prices at different locations.
• Generic Availability: Quviviq is currently only available as a brand-name medication. There is no lower-cost generic version available at this time, which typically keeps the price higher than older insomnia medications.

Financial Assistance Options

If you do not have insurance or if your copay is high, there may be options to reduce the cost:

• Manufacturer Savings Cards: The drug manufacturer may offer a savings card for patients with commercial insurance that can lower the monthly cost to a fixed amount.
• Patient Assistance Programs: Some programs provide the medication at a reduced cost or for free to individuals who meet specific income and eligibility requirements, particularly those without insurance coverage.