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  5. Drug Trials Snapshots: QUVIVIQ
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Drug Trials Snapshots: QUVIVIQ

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT

Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug. 

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).  Refer to the QUVIVIQ Prescribing Information for all of the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).  

QUVIVIQ (daridorexant)
cue-VIH-vick
Idorsia Pharmaceuticals Ltd
Approval date:
01/07/2022


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

QUVIVIQ is a prescription medicine that is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

How is this drug used?

QUVIVIQ is a taken orally no more than once per night within 30 minutes of going to bed.

Who participated in the clinical trials?

The FDA approved QUVIVIQ based on evidence from two clinical studies [Study 1 (NCT03545191) and Study 2 (NCT03575104)]    of 1,854 patients    with chronic insomnia (sleep problems that have been happening most of the time for at least 3 months). The studies were conducted at 154 sites in 18 countries (Australia, Belgium, Bulgaria Canada, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Poland, Republic of South Korea, Serbia, Spain, Sweden, Switzerland, and the USA).

What are the benefits of this drug?

On average, patients who received QUVIVIQ fell asleep faster at bedtime, spent less time awake at night after first falling asleep, and felt they slept longer, compared to patients who received placebo.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: QUVIVIQ worked similarly in males and females
  • Race: The number of patients of races other than White was small; therefore, differences in how QUVIVIQ worked among races could not be determined.  
  • Age: QUVIVIQ worked similarly in patients younger and older than 65 years of age.

What are the possible side effects?

The most common side effects of QUVIVIQ are headache and sleepiness.

Sleep medicine, such as QUVIVIQ, may cause serious side effects including:

  • Decreased awareness and alertness.
  • Worsening depression and suicidal thoughts. 
  • Temporary inability to move or talk while going to sleep or waking up (sleep paralysis) for up to several minutes.
  • Hallucinations while going to sleep or waking up. 
  • Complex sleep behaviors (e.g., sleep-walking, sleep-driving).

Were there any differences in side effects among sex, race and age?

  • Sex: The occurrence of side effects was similar in males and females
  • Race: The number of patients of races other than White was small; therefore, differences in the occurrence of side effects could not be determined.  
  • Age: The occurrence of somnolence or fatigue side effects were greater in patients above 65 years of age.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the trials?

How were the trials designed?

QUVIVIQ was evaluated in two clinical studies for efficacy (how well the drug works) and safety (what the side effects are). The patients in the studies had chronic insomnia (sleep problems that have been happening most of the time for at least 3 months).

In Study 1, adult patients (18 years old and above) were given 25 mg QUVIVIQ  pills,  50 mg QUVIVIQ  pills, or placebo pills (identical-appearing pill with no drug in it) to take every night for 3 months. In Study 2, adult patients (18 years old and above) were given 10 mg QUVIVIQ  pills,  25 mg QUVIVIQ  pills, or placebo pills (identical-appearing pill with no drug in it) to take every night for 3 months. The 10 mg dose is not an approved dose. It did not work better than placebo. 

In both studies, the pills looked identical so neither the patients nor the healthcare providers knew which pill was being given. Sleep was measured using polysomnography (PSG), an overnight test done in a sleep laboratory, and by using a sleep diary where patients wrote how long they felt they slept each night. The benefit of QUVIVIQ was evaluated by comparing the QUVIVIQ and placebo groups’ changes in sleep (based on PSG and the sleep diary).

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

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