QUVIVIQ was approved by the Food and Drug Administration in early January for adults who have difficulty falling asleep or sleeping (insomnia). The product was first marketed on May 2ndthrough the pharmacy service provider, and all retail pharmacies will be able to order the product through their wholesalers starting May 16.
“We are extremely excited that the first patients in the United States have been prescribed QUVIVIQ,” he said Patrizia TorrPresident and CEO of Idorsia US “After the first week of product availability through our partnership with pharmaceutical service providers, engagement with healthcare professionals and patient adoption trends are very positive and encouraging.”
Insomnia is the most common sleep disorder, affecting more than 25 million adults in the United States1 Sleep is underrated as the third pillar of health, after diet and exercise, particularly with regards to the significant direct consequences it has on our daily lives. The effects of sleep, especially the lack of sleep quality, are felt by people during the day; it impairs health and daily life, from a weakened immune system to challenges with memory and attention.2.3
QUVIVIQ 25mg and 50mg are FDA approved and available for the treatment of adult patients with insomnia, characterized by difficulty with initiating sleep and / or maintaining sleep. QUVIVIQ is recommended once per night, taken orally within 30 minutes of going to bed, with at least seven hours remaining before scheduled awakening.4
Adults struggling with sleep should speak to their doctor to see if QUVIVIQ is the right treatment option for them. For more information, see the complete prescribing information (PI and Medication Guide).
QUVIVIQ is a prescription medicine for adults who have difficulty falling or staying asleep (insomnia).
Important safety information
Do not get QUVIVIQ if you often falling asleep at unexpected times (narcolepsy).
QUVIVIQ can cause serious side effects, including:
- Decreased awareness and alertness. In the morning after taking QUVIVIQ, your ability to drive safely and think clearly may be impaired. You may also feel sleepy 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 need to be active again.
- Take QUVIVIQ in the evening within 30 minutes before going to bed.
QUVIVIQ is a federally controlled substance because it can be abused or lead to addiction.
Before taking QUVIVIQ, tell your doctor about all of your medical conditions, including if:
- having 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
- I am pregnant or planning to become pregnant
- are breastfeeding or planning to breastfeed
Tell your doctor about all the medicines you takeincluding prescription and over-the-counter drugs, vitamins, and herbal supplements.
- Taking QUVIVIQ with some medicines can cause serious side effects. QUVIVIQ can affect the way other medicines work and some other medicines can affect the way QUVIVIQ works.
- Do not take QUVIVIQ with other medicines that may make you sleepy unless directed by your doctor.
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.
- You do not drive, operate heavy machinery, do nothing dangerous or perform other activities that require clarity of thought if you do not feel fully awake, or if you took QUVIVIQ and slept less than a full night (at least 7 hours) or if you have took more QUVIVIQ than prescribed.
QUVIVIQ can cause other serious side effects, including:
- Worsening depression and suicidal thoughts. Call your doctor right away if you have worsening depression or thoughts of suicide or death.
- Temporary inability to move or speak (sleep paralysis) for several minutes or hallucinate while you sleep or wake up.
- Complex sleep behaviors such as walking in your sleep, driving in your sleep, preparing and eating food, making phone calls, having sex, or doing other activities while you are not fully awake that you may not remember the next morning. Stop taking QUVIVIQ and call your doctor right away if you experience complex sleep behavior.
The most common side effects of QUVIVIQ are headaches and drowsiness.
These are not all 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.
Notes to the editor
Insomnia is defined as a combination of difficulty getting sufficient sleep and sleep dissatisfaction combined with a significant negative impact on daytime functioning. Insomnia disorder is defined as difficulty initiating and / or maintaining sleep for at least three nights a week for at least three months, despite adequate sleep.
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 around 10%. On this basis, and assuming an adult population in the United States of approximately 250 million, there are approximately 25 million adults in the United States living with insomnia.
Insomnia as a chronic disorder differs from a short period of poor sleep and can have repercussions on physical and mental health. It can be a persistent condition with a negative impact on daytime functioning. Idorsia’s research has shown that poor quality sleep can affect many aspects of daily life, including ability to concentrate, mood and energy levels.
The goals of insomnia management are to improve sleep quality and quantity, as well as daytime functioning. The current recommended treatment of insomnia includes recommendations on sleep hygiene, cognitive behavioral therapy, and pharmacotherapy.
- 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.
- Savard J, et al. Psychosomatic Medicine: 2003; 65 (2): 211-221
- Fortier-Brochu E, et al. Sleep. 2014; 37 (11): 1787-98.
- QUVIVIQ prescribing information. Idorsia Pharmaceuticals USA Inc. [01/22]
About Idorsia USA
Idorsia US, a subsidiary of Idorsia, is trying to achieve more: we have more ideas, we see more opportunities and we want to help more patients. To achieve this, we will help transform Idorsia into a leading biopharmaceutical company with a strong scientific core. With commercial operations based outside of Philadelphia, Pennsylvania, one of the densest communities of life sciences talent in the world, we are helping to realize the company’s ambition to bring innovative medicines from the counter to the patient’s bed. Our goal is to create a commercial footprint that brings Idorsia’s vast product pipeline from its research and development engine to the US market, with the potential to change the lives of many patients.
For more information, please contact
Senior Director, Chief of Communications for the United States
Idorsia Pharmaceuticals USA, 100 Matsonford Road, Radnor, Pennsylvania 19087
+1 (215) 421 4887
Andrew C. Weiss
Senior Vice President, Head of Investor Relations & Corporate Communications
Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil
+41 58 844 10 10
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SOURCE Idorsia Pharmaceuticals USA