Idorsia Announces World Champion Skier, Philanthropist and Entrepreneur Lindsey Vonn as Patient Ambassador for QUVIVIQ™ (daridorexant), a Once Nightly Treatment for Insomnia

Insomnia is the most common sleep disorder, affecting more than approximately 25 million adults in the U.S.^2,3 Sleep is underrecognized as the third pillar of health, next to diet and exercise, particularly regarding the significant direct consequences it has on daily lives. The effects of sleep, particularly lack of sleep, in adults with insomnia, are felt by people during the day.⁴

Vonn is no stranger to insomnia. Her trouble sleeping began after she sustained a serious knee injury in 2013, and her recovery brought not only physical pain, but also concerns about her overall health, which prevented her from getting the rest she needed. Upon retiring, Vonn thought that without the stress of competition, her insomnia would improve, but as her goals shifted to succeeding in the business world, she continued to have difficulty sleeping and would lie awake at night for hours trying to fall asleep.

“In an effort to manage my insomnia, I tried several over-the-counter and prescription treatments – along with strategies to improve my sleep hygiene – and found no success. I talked with my doctor and was prescribed QUVIVIQ, a new prescription treatment for adults with insomnia,” says Vonn. “I’m grateful to have found a treatment option that works for me, and I urge those who struggle with sleep to start a dialogue with their doctor so they can find a solution too.”

Vonn joins esteemed actor, author, father and fellow QUVIVIQ patient ambassador Taye Diggs in sharing her unique and personal experience of living with insomnia to encourage people to talk with their doctor and find a solution that works for them. Vonn also shares her personal sleep story and experience with QUVIVIQ, which can be found at QUVIVIQ.com and across digital mediums, including QUVIVIQ’s Facebook, Twitter and Instagram channels.

“Lindsey’s experience with trouble sleeping is a story all-too-familiar for people struggling with insomnia. We are excited to enter into a partnership with such a strong advocate for the sleep community and continue to provide a platform for real people like Lindsey and Taye to share their personal experiences,” says Patricia Torr, President and General Manager of Idorsia U.S. “Through our partnerships with Lindsey and Taye, we are continuing to spread awareness around the realities of living with insomnia and encourage people to discuss their sleep struggles with their doctor.”

QUVIVIQ 25mg and 50mg tablets are FDA approved and available for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. QUVIVIQ is recommended once per night, taken orally within 30 minutes before going to bed, with at least seven hours remaining prior to planned awakening.¹ In clinical studies, QUVIVIQ helped adults with insomnia fall asleep faster and stay asleep longer with improvements measured at month 1 and 3. The most common side effects were headaches and sleepiness. Because QUVIVIQ may cause sleepiness during the day, patients should avoid driving or other activities that require clear thinking until they feel fully awake.

QUVIVIQ™ (daridorexant) CIV is Idorsia’s first approved and commercially available medicine in the U.S. and exemplifies the company’s deep scientific roots and commitment to discovering, developing and bringing new medicines to patients to fulfill unmet needs.

Adults struggling with sleep should speak with their doctor to see if QUVIVIQ is the right treatment option for them. For more information, see the Full Prescribing Information (PI and Medication Guide).

About QUVIVIQ

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). 

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 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.
• 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 of QUVIVIQ are headache and sleepiness.

These are not all of the possible side effects of QUVIVIQ. Call your doctor for medical 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.

About Lindsey Vonn’s Sleep Story

Lindsey Vonn’s trouble sleeping began after she sustained a serious knee injury in 2013. While recovering, she experienced physical pain and concerns about her overall health that yielded notable trouble sleeping. She thought that she might find rest upon retiring but was surprised to find that her insomnia did not improve. Like she did in her athletic pursuits, when Vonn was faced with a challenge, she turned to professionals for help. Vonn’s doctor prescribed her QUVIVIQ and after taking QUVIVIQ nightly, she started to notice a difference in her sleep. As a QUVIVIQ patient ambassador, Vonn hopes to help educate people about insomnia, specifically that it is a real medical condition that deserves to be treated as such, as well as inspire others experiencing trouble sleeping to speak with their doctors about a treatment option that may work for them.

About Insomnia

Insomnia is defined as a combination of difficulty obtaining sufficient sleep and dissatisfaction with sleep combined with a significant negative impact on daytime functioning. Insomnia disorder is defined as difficulty initiating and/or maintaining sleep on at least three nights per week for at least three months, despite adequate opportunity to sleep.⁴

Insomnia is a condition of overactive brain activity during sleep, and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia.

Significant insomnia is a common problem with a prevalence of approximately 10%.² On this basis, and assuming a U.S. adult population of around 250 million, there are approximately 25 million adults in the U.S. living with insomnia.³

Insomnia as a chronic disorder is different from a brief period of poor sleep, and it can take its toll on both physical and mental health. It can be a persistent condition with a negative impact on daytime functioning.⁴ Idorsia’s research has shown that poor-quality sleep can affect many aspects of daily life, including the ability to concentrate, mood, and energy levels.

The goals of managing insomnia are to improve sleep quality and quantity, as well as daytime functioning. Current recommended treatment of insomnia includes sleep hygiene recommendations, cognitive behavioral therapy, and pharmacotherapy.

References

1. QUVIVIQ™ (daridorexant) [prescribing information]. Radnor, PA: Idorsia Pharmaceuticals U.S. Inc; 2022.
2. Bhaskar S, Hemavathy D, Prasad S. Prevalence of chronic insomnia in adult patients and its correlation with medical comorbidities. J Family Med Prim Care. 2016;5(4):780-784. doi:10.4103/2249-4863.201153.
3. Ogunwole S, Rabe M, Roberts A, et al. United States Census Bureau. Population under age 18 declined last decade. https://www.census.gov/library/stories/2021/08/united-states-adult-population-grew-faster-than-nations-total-population-from-2010-to-2020.html. Accessed May 12, 2022.
4. DSM-5. Washington, DC: American Psychiatric Association; 2013.

About Idorsia U.S.

Idorsia U.S., an affiliate of Idorsia, is reaching out for more – we have more ideas, we see more opportunities, and we want to help more patients. To achieve this, we will help develop Idorsia into a leading biopharmaceutical company, with a strong scientific core. With commercial operations based outside of Philadelphia, PA, one of densest communities of life sciences talent in the world, we are helping to realize the company’s ambition of bringing innovative medicines from bench to bedside. Our goal is to build a commercial footprint that will deliver Idorsia’s deep pipeline of products from its R&D engine to the U.S. market – with the potential to change the lives of many patients.

SOURCE Idorsia Pharmaceuticals U.S./PR Newswire