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Quviviq (Daridorexant): FDA-Approved Drug for Insomnia

Written By Edibel Quintero, MD

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Amongst sleep disorders, insomnia stands as one of the most common and debilitating conditions affecting individuals worldwide. With the FDA approval of Quviviq (daridorexant) in January 2022, there is renewed hope for people with insomnia. This article will review how Quviviq works, its dosage, available strengths, benefits, side effects, essential precautions, and warnings.

Key takeaways:

  • Quviviq (daridorexant) represents a new class of medications called dual orexin receptor antagonists (DORAs). Unlike traditional sleep aids, which often target specific neurotransmitters, Quviviq blocks unique orexin receptors in your brain, regulating the sleep-wake cycle.
  • Extensive clinical trials have revealed Quviviq’s effectiveness in alleviating insomnia. The drug has significantly improved sleep onset, maintenance, and overall sleep quality compared to a placebo. The way Quviviq works helps promote sustained sleep throughout the night.
  • Quviviq has been well-tolerated in clinical trials, with minimal reports of side effects. Common adverse reactions include headaches, somnolence (excessive sleepiness), and fatigue. The drug’s safety profile is a notable advantage compared to older generations of sleep aids.
  • Quviviq’s unique mechanism of action makes it a non-habit-forming option for insomnia. Unlike traditional sedatives with the risk of dependency or withdrawal symptoms, Quviviq does not have these concerns.
  • Quviviq is a prescription medication that requires the supervision of a healthcare professional. Before prescribing Quviviq, your physician will consider your medical history, current medications, and potential drug interactions.

We’ll also provide a comparative analysis of Quviviq against other insomnia drugs, equipping you with the knowledge needed to make an informed decision.

What is Quviviq and how does it work?

Quviviq, also known by its generic name, daridorexant, is a novel drug formulated to combat insomnia in adults who have trouble falling and staying asleep. It belongs to a class of medications called dual orexin receptor antagonists (DORAs). Orexin is a brain chemical that promotes daytime wakefulness and arousal. Quviviq selectively blocks the action of orexin, making you fall asleep faster and stay asleep longer.

Quviviq is available in tablet form and is generally taken once every night. Its specific dosage may vary based on individual factors, such as the severity of your condition and other relevant factors.

The typical starting dose of Quviviq is 25 mg, taken once daily before bedtime. Your healthcare provider will closely monitor your progress and make the necessary dosage adjustments. The goal is to find the optimal dosage that effectively delivers the required therapeutic effect without posing serious side effects. The drug comes in two strengths: 25 mg and 50 mg.

Benefits of Quviviq

Quviviq has been shown to be effective in improving sleep quality and quantity in adults with insomnia.

In two large clinical trials involving more than 1800 patients, Quviviq significantly improved sleep latency and efficiency compared to the placebo. Sleep latency is the time you spend in bed before drifting off to sleep. Sleep efficiency, on the other hand, is the total time spent asleep.

Additionally, Quviviq improved subjective measures of sleep quality, such as feeling refreshed and satisfied with sleep in the morning; participants also reported enhanced daytime functioning and quality of life.

Moreover, Quviviq has a low potential for abuse or dependence, unlike other insomnia drugs (such as benzodiazepines or non-benzodiazepine hypnotics). It does not typically cause rebound insomnia or withdrawal symptoms when discontinued.

Potential side effects of Quviviq

According to clinical trials, Quviviq is generally well-tolerated by most individuals. However, like any medication, it can cause side effects in some. To simplify, we’ll divide these adverse effects into more common but less severe ones and more serious consequences.

The most commonly reported side effects of Quviviq are usually mild to moderate and affect fewer than 10% of people. These include headaches, excessive sleepiness, dizziness, changes in appetite, and fatigue.

In addition to the common side effects, Quviviq may give rise to more serious consequences warranting medical attention. These are discussed in more detail below.

Slowed brain activity and daytime impairment

Quviviq can make you less alert and coordinated, especially in the morning. This can raise your risk of getting hurt or causing accidents. The chances of this side effect are greater if you fail to allocate sufficient time to sleep.

Due to the (limited) risk of daytime hangovers, you should refrain from driving or operating machinery until you understand how this medicine affects you. Additionally, it’s advisable to stay away from alcohol or other drugs that induce drowsiness while taking Quviviq.

Worsening of depression or risk of self-harm

Quviviq can trigger feelings of low mood or, in worse-case scenarios, suicidal thoughts. Be sure to inform your doctor if you’ve ever had depression or suicidal thoughts or actions before starting this sleeping pill.

Risky sleep behaviors

Quviviq may cause you to do things while not fully awake, such as sleepwalking, sleep-driving, or other risky activities. You may have no recollection of these activities the following day.

Nonetheless, these behaviors can pose dangers to yourself and others. Thus, if you discover you’ve engaged in any of these activities, you should immediately stop taking this drug and call your doctor.

Does Quviviq really treat insomnia?

Quviviq is a medication that can help you sleep better, but it’s not a cure for insomnia. Insomnia is a complex condition with many causes and contributing factors, such as stress, anxiety, depression, medical conditions, lifestyle habits, or environmental factors.

This sleeping pill can help mitigate the symptoms of insomnia, but it doesn’t address the underlying causes. Therefore, you should not rely on Quviviq alone to treat your insomnia. In fact, it’s best to consult your doctor about other possible treatments, such as cognitive behavioral therapy for insomnia (CBT-I). This form of psychotherapy can help you tweak your thoughts and behaviors related to sleep and make Quviviq work better for you.

In addition, you can optimize the benefits of Quviviq by practicing good sleep hygiene. This entails following simple tips to create an ideal sleep environment and establish bedtime routines.

What should you consider before taking Quviviq?

Before taking Quviviq, talk to your doctor about your medical history, current medications, and allergies. This sedative may not be suitable for everyone. Some of the noticeable instances where you should practice caution before taking Quviviq include:

  • Narcolepsy. You cannot take Quviviq if you have narcolepsy, a sleep disorder that causes excessive daytime sleepiness and sudden sleep attacks. It may worsen the symptoms of narcolepsy or interfere with the treatment of narcolepsy.
  • Liver problems. Your liver is the primary organ that metabolizes Quviviq. Hence, this drug may accumulate if you have liver damage. Check with your doctor if Quviviq is the right option for you.
  • Compromised lung function. Quviviq may impact your breathing during sleep. This is particularly true if you have a pre-existing lung condition such as asthma, chronic obstructive pulmonary disease, or sleep apnea. Therefore, remember to notify your doctor about any breathing problems before starting Quviviq.
  • Pregnancy and breastfeeding. There’s not enough data on the safety and efficacy of Quviviq in pregnant or breastfeeding women. Be sure to inform your doctor if you’re pregnant or planning to conceive before taking Quviviq. It’s also best to avoid breastfeeding while taking Quviviq.

How to take Quviviq

To take Quviviq, follow these steps:

  • Swallow one pill with water approximately 30 minutes before your intended bedtime.
  • Ensure you can dedicate at least 7 hours to sleep after taking Quviviq to minimize after-effects like drowsiness, headaches, and fatigue.
  • Avoid taking Quviviq with or immediately after a meal, as this could delay its onset of action.
  • Remember to adhere to your doctor’s instructions, as with any other medication.

Quviviq: possible drug interactions

Quviviq, like any other medication, has the potential to interact with other medicines. It is important to tell your doctor about all your medications, including prescriptions, over-the-counter drugs, and herbal supplements.

Your clinician can assess possible interactions and make appropriate recommendations to ensure the safe and effective use of Quviviq.

Interaction with drugs that block CYP3A4

An enzyme called CYP3A4 is responsible for breaking down many drugs in your body, including Quviviq.

Some drugs block the activity of this enzyme, leading to increased blood levels of Quviviq when taken together. The raised blood levels of this sedative make you more prone to its side effects.

Examples of drugs that inhibit CYP3A4 include ketoconazole, itraconazole, clarithromycin, or ritonavir.

Interaction with drugs that induce CYP3A4

Conversely, certain drugs induce CYP3A4, causing the blood levels of Quviviq to fall when taken concurrently. Hence, reduced blood levels make it less effective.

Examples of drugs that induce CYP3A4 include rifampin, carbamazepine, phenytoin, and St. John’s wort.

Interaction with other sedatives

Taking Quviviq with other sedatives can amplify their sedative effects. Excessive sedation can increase your risk of respiratory depression and other repercussions that slow down your brain activity.

In worst cases, the combination may result in severe drowsiness, difficulty breathing, coma, or even death.

Comparison: Quviviq vs. other insomnia drugs

We know that many other drugs are available to treat insomnia. Some of the most commonly used ones are benzodiazepines and non-benzodiazepine hypnotics. Let’s see how Quviviq compares to them:

  • Mechanism of action. Quviviq works by blocking orexin, a brain chemical that keeps you awake. In contrast, benzodiazepines and non-benzodiazepine hypnotics work by increasing GABA, a chemical that promotes sleepiness.
  • Half-live. Quviviq has a shorter half-life than most sleeping pills, including suvorexant. This means it exits your body faster, potentially resulting in reduced daytime sleepiness and impairment. It’s worth noting that suvorexant, another insomnia medication, operates in a similar manner to Quviviq.
  • Next-day hangover. Quviviq works for a shorter time than suvorexant, which may reduce the risk of a next-day hangover.
  • Physical dependence. According to the FDA, Quviviq has a lower risk of causing rebound insomnia and physical dependence than other insomnia medications.
  • Risk of memory impairment. Quviviq may affect memory, especially if you don’t get enough sleep or exceed the prescribed dose. However, based on a scientific review, Quviviq appears to have a different effect on attention, memory, learning, and cognition than other insomnia drugs.

Does insurance cover Quviviq?

The out-of-pocket price of 25 mg of Quviviq averages about $515 for a 30-day supply. However, this cost can differ depending on your chosen pharmacy. And it may not be applicable if you have insurance coverage. You should check with your insurance provider for the specific prices and coverage details related to Quviviq.

The coverage of Quviviq by insurance plans can vary depending on your provider’s policies. Some insurance plans may cover this medicine, while others may require prior authorization or have specific criteria for coverage.

It’s best to check with your insurance provider or consult your doctor to determine the coverage details and any potential requirements for obtaining insurance coverage for Quviviq.

Quviviq (daridorexant) is an FDA-approved medication that offers hope to those with insomnia. It helps improve sleep quality and tackle the challenges of insomnia. What’s interesting about Quviviq is that it works differently from other sleep aids and is safe to use. It doesn’t cause dependence or withdrawal symptoms. However, it’s imperative to seek guidance from a healthcare professional, stick to the prescribed dose, and be mindful of potential side effects.

FAQ

How long does it take for Quviviq to leave your system?

Quviviq’s package insert reveals that it has a half-life of 8 hours. This implies that half of the drug dissipates from your system within that time. However, the entire drug may take several days to leave your body, depending on your age, weight, liver function, and other medications you take.

How to know if you’ve accidentally taken too much Quviviq?

Taking more than the prescribed dose can lead to a Quviviq overdose with serious consequences. Symptoms may include excessive sleepiness, sleep paralysis, difficulty concentrating, constipation, fatigue, and sudden muscle weakness (cataplexy).

What should I do if I overdosed on Quviviq?

In the event of an overdose of Quviviq, there is no known specific antidote. If you or someone else takes too much Quviviq, contact your doctor immediately or visit the nearest emergency room. Additionally, contact the poison control center for further assistance and guidance. Prompt medical attention is paramount to ensure appropriate care and support.

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Written by

Edibel Quintero is a health journalist focusing on all aspects of health and wellness. She has extensive experience as a newspaper columnist, feature writer, and reporter. In her spare time, she serves as governance board vice president for Lakeland STAR School/Academy, a charter school for autistic and diverse learners.

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