An opportunity to say goodnight insomnia, hello tomorrow

Explore QUVIVIQ endpoints across both night & day

Nighttime

Statistically significant nighttime improvements vs placebo1

Daytime

Statistically significant reduction in daytime sleepiness with QUVIVIQ 50 mg vs placebo2

The safety and efficacy of QUVIVIQ was evaluated in 2 multicenter, randomized, double-blind, placebo-controlled, parallel-group studies over 3 months, followed by a 40-week extension safety study. Study 1 (N=930) included QUVIVIQ 25 mg (n=310), QUVIVIQ 50 mg (n=310), and placebo (n=310). Study 2 (N=617) included QUVIVIQ 25 mg (n=309) and placebo (n=308).1 The extension safety study (N=662) included QUVIVIQ 25 mg (n=270), QUVIVIQ 50 mg (n=137), placebo (n=128), and ex-placebo to QUVIVIQ 25 mg (n=127).4

Key primary endpoints

Change from baseline to Month 1 and Month 3 measured by polysomnography in:

  • Latency to Persistent Sleep (LPS)
  • Wake After Sleep Onset (WASO)

Key secondary endpoints

  • Patient-reported total sleep time (sTST)
  • Patient-reported sleepiness domain of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ)3

Select inclusion criteria

  • Age ≥18 years
  • Insomnia according to DSM-5 criteria
  • Sleep Severity Index ≥15

Select exclusion criteria

  • Any other condition causing insomnia
  • Ongoing cognitive behavioral therapy, shift work, travel over time zones

Patient population

  • QUVIVIQ was evaluated in a total of 1,236 patients, including ~40% elderly patients (≥65 years old)
  • A total of 576 patients were treated with QUVIVIQ for at least 6 months, including 331 treated for at least 12 months

IDSIQ is the first patient-reported outcome tool developed and validated according to FDA guidelines that can evaluate daytime symptoms in patients with insomnia.3

IDSIQ is a validated tool based on the Daytime Insomnia Symptom Scale and includes 14 items across 3 domains: sleepiness, mood, and alert/cognition.3

A key secondary endpoint in the QUVIVIQ clinical trials was change from baseline in the IDSIQ sleepiness domain score at Month 1 and Month 3. Patients completed daily self-assessments about how energetic, mentally and physically tired, or sleepy they felt during treatment with QUVIVIQ.2,3

IDSIQ, Insomnia Daytime Symptoms and Impacts Questionnaire; LPS, latency to persistent sleep; WASO, wake after sleep onset; sTST, subjective total sleep time.

Nighttime

QUVIVIQ helps patients

Fall asleep faster1

Less time needed to fall asleep, minutes (Study 1, primary endpoint)

Latency to persistent sleep (LPS), assessed objectively by polysomnography

STUDY 1

Month 1

Month 3

Placebo

25 mg

50 mg

Placebo

25 mg

50 mg

Change from baseline LSM (95% CL)

-20
[-23, -17]

-28
[-32, -25]

-31
[-35, -28]

-23
[-26, -20]

-31
[-34, -27]

-35
[-38, -31]

Difference to placebo LSM (95% CL)

-8*

[-13, -4]

-11*

[-16, -7]

-8*

[-12, -3]

-12*

[-16, -7]

STUDY 1

Month 1

Placebo

25 mg

50 mg

Change from baseline LSM (95% CL)

-20
[-23, -17]

-28
[-32, -25]

-31
[-35, -28]

Difference to placebo LSM (95% CL)

-8*

[-13, -4]

-11*

[-16, -7]

STUDY 1

Month 3

Placebo

25 mg

50 mg

Change from baseline LSM (95% CL)

-23
[-26, -20]

-31
[-34, -27]

-35
[-38, -31]

Difference to placebo LSM (95% CL)

-8*

[-12, -3]

-12*

[-16, -7]

  • Doses that were statistically significantly superior (p<0.05) to placebo after controlling for multiple comparisons.
    CL, confidence limit; LSM, least squares mean.

QUVIVIQ helps patients

Spend more time asleep after onset1

Improved sleep maintenance, minutes (Study 1, primary endpoint)

Wake after sleep onset (WASO), assessed objectively by polysomnography

STUDY 1

Month 1

Month 3

Placebo

25 mg

50 mg

Placebo

25 mg

50 mg

Mean WASO

92 min

77 min

65 min

87 min

73 min

65 min

Change from baseline LSM (95% CL)

-6
[-10, -2]

-18
[-22, -15]

-29
[-33, -25]

-11
[-15, -7]

-23
[-27, -19]

-29
[-33, -25]

Difference to placebo LSM (95% CL)

-12*
[-17, -7]

-23*
[-28, -18]

-12*
[-17, -6]

-18*
[-24, -13]

STUDY 1

Month 1

Placebo

25 mg

50 mg

Mean WASO

92 min

77 min

65 min

Change from baseline LSM (95% CL)

-6
[-10, -2]

-18
[-22, -15]

-29
[-33, -25]

Difference to placebo LSM (95% CL)

-12*
[-17, -7]

-23*
[-28, -18]

STUDY 1

Month 3

Placebo

25 mg

50 mg

Mean WASO

87 min

73 min

65 min

Change from baseline LSM (95% CL)

-11
[-15, -7]

-23
[-27, -19]

-29
[-33, -25]

Difference to placebo LSM (95% CL)

-12*
[-17, -6]

-18*
[-24, -13]

  • Doses that were statistically significant superior (p<0.05) to placebo after controlling for multiple comparisons.
    CL, confidence limit; LSM, least squares mean.

QUVIVIQ helps patients

Gain more total sleep time1

Increased subjective total sleep time, minutes (Study 1, secondary endpoint*)

Subjective total sleep time (sTST), patient-reported

STUDY 1

Month 1

Month 3

Placebo

25 mg

50 mg

Placebo

25 mg

50 mg

Mean sTST

338 min

345 min

358 min

354 min

358 min

372 min

Change from baseline LSM (95% CL)

22
[16, 27]

34
[29, 40]

44
[38, 49]

38
[31, 44]

48
[41, 54]

58
[51, 64]

Difference to placebo LSM (95% CL)

13
[5, 20]

22
[14, 30]

10
[1, 19]

20
[11, 29]

STUDY 1

Month 1

Placebo

25 mg

50 mg

Mean sTST

338 min

345 min

358 min

Change from baseline LSM (95% CL)

22
[16, 27]

34
[29, 40]

44
[38, 49]

Difference to placebo LSM (95% CL)

13
[5, 20]

22
[14, 30]

STUDY 1

Month 3

Placebo

25 mg

50 mg

Mean sTST

354 min

358 min

372 min

Change from baseline LSM (95% CL)

38
[31, 44]

48
[41, 54]

58
[51, 64]

Difference to placebo LSM (95% CL)

10
[1, 19]

20
[11, 29]

  • Change from baseline at Months 1 and 3.
  • Doses that were statistically significant superior (p<0.05) to placebo after controlling for multiple comparisons.
    CL, confidence limit; LSM, least squares mean.

Improvements with nightly QUVIVIQ were seen at Week 1 and continued to build over 3 to 4 weeks1*

*Based on sTST data.

Daytime

With QUVIVIQ 50 mg

Patients reported statistically significant reduction in daytime sleepiness²

Reduced daytime sleepiness compared with placebo (Study 1, secondary endpoint)

Improvements in IDSIQ sleepiness domain score, patient-reported

Change from baseline was greater with QUVIVIQ 50 mg than placebo at Months 1 and 3, showing greater reduction in daytime sleepiness
  • Improvement in IDSIQ sleepiness domain score was significant at Month 1 and Month 3 for QUVIVIQ 50 mg in a single adequate and well-controlled study
  • Sleepiness domain scores for QUVIVIQ 25 mg were not significant at Month 1 or Month 3 in either Study 1 or Study 2

STUDY 1

Month 1

Month 3

Placebo
(N=310)

50 mg
(N=310)

Placebo
(N=310)

50 mg
(N=310)

Change from baseline LSM (95% CL)

-2.0
[-2.6 to -1.5]

-3.8
[-4.3 to -3.2]

-3.8
[-4.5 to -3.1]

-5.7
[-6.4 to -5.0]

Difference to placebo LSM (95% CL)

-1.8*
[-2.5 to -1.0]

-1.9
[-2.9 to -0.9]

STUDY 1

Month 1

Placebo
(N=310)

50 mg
(N=310)

Change from baseline LSM (95% CL)

-2.0
[-2.6 to -1.5]

-3.8
[-4.3 to -3.2]

Difference to placebo LSM (95% CL)

-1.8*
[-2.5 to -1.0]

STUDY 1

Month 3

Placebo
(N=310)

50 mg
(N=310)

Change from baseline LSM (95% CL)

-3.8
[-4.5 to -3.1]

-5.7
[-6.4 to -5.0]

Difference to placebo LSM (95% CL)

-1.9
[-2.9 to -0.9]

  • p<0.0001.
  • p=0.0002.
    CL, confidence limit; LSM, least squares mean.

With QUVIVIQ 50 mg

Reductions in daytime sleepiness were reported at Week 1 and continued to improve over time2,4

Reduced daytime sleepiness compared with placebo (Study 1)

Improvements in IDSIQ sleepiness domain score, self-reported by the patient

Change from baseline by week showed reductions at Week 1 that continued over time. Significance was assessed at Months 1 and 3 only. Weekly results were exploratory and are descriptive only
  • Improvement in IDSIQ sleepiness domain score was significant at Month 1 and Month 3 for QUVIVIQ 50 mg in a single adequate and well-controlled study
  • Sleepiness domain scores for QUVIVIQ 25 mg were not significant at Month 1 or Month 3 in either Study 1 or Study 2

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Idorsia Medical Information

Important Safety Information

Contraindications

QUVIVIQ is contraindicated in patients with narcolepsy.

Warnings and Precautions

Central Nervous System (CNS) Depressant Effects and Daytime Impairment

QUVIVIQ can impair daytime wakefulness. CNS depressant effects may persist in some patients up to several days after discontinuing QUVIVIQ. Advise patients about the potential for next-day somnolence.

INDICATION

QUVIVIQ (daridorexant) is indicated for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

INDICATION

QUVIVIQ (daridorexant) is indicated for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

Important Safety Information

Contraindications

QUVIVIQ is contraindicated in patients with narcolepsy.

Warnings and Precautions

Central Nervous System (CNS) Depressant Effects and Daytime Impairment

QUVIVIQ can impair daytime wakefulness. CNS depressant effects may persist in some patients up to several days after discontinuing QUVIVIQ. Advise patients about the potential for next-day somnolence.

Driving ability was impaired in some subjects taking QUVIVIQ 50 mg. Risk of daytime impairment is increased if QUVIVIQ is taken with less than a full night of sleep or at a higher than recommended dose. If taken in these circumstances, caution patients against driving or other activities requiring complete mental alertness.

Use with other CNS depressants increases the risk of CNS depression, which can cause daytime impairment. Dosage adjustments of QUVIVIQ and CNS depressants may be necessary when administered together. Use with other insomnia drugs is not recommended. Advise patients not to consume alcohol in combination with QUVIVIQ.

Worsening of Depression/Suicidal Ideation

Patients with psychiatric disorders including insomnia are at increased risk of suicide. In primarily depressed patients treated with hypnotics, worsening of depression, suicidal thoughts and actions (including completed suicides) have been reported. Administer with caution in patients exhibiting symptoms of depression. Monitoring suicide risk and protective measures may be required.

Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-Like Symptoms

Sleep paralysis, an inability to move or speak for up to several minutes during sleep-wake transitions, and hypnagogic/hypnopompic hallucinations, including vivid and disturbing perceptions, can occur with QUVIVIQ. Explain these events to patients.

Symptoms similar to mild cataplexy have been reported with orexin receptor antagonists and can include periods of leg weakness lasting from seconds to a few minutes, can occur at night or during the day, and may not be associated with a triggering event (e.g., laughter or surprise).

Complex Sleep Behaviors

Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in activities while not fully awake (e.g., preparing and eating food, making phone calls, having sex), have been reported to occur with the use of hypnotics, including orexin receptor antagonists, such as QUVIVIQ. These events can occur in hypnotic-naïve as well as in hypnotic-experienced persons. Patients usually do not remember these events. Complex sleep behaviors may occur following the first or any subsequent use of hypnotics, with or without the concomitant use of alcohol and other CNS depressants. Discontinue QUVIVIQ immediately if a patient experiences a complex sleep behavior.

Patients with Compromised Respiratory Function

The effects of QUVIVIQ on respiratory function should be considered for patients with compromised respiratory function. QUVIVIQ has not been studied in patients with moderate obstructive sleep apnea (OSA) requiring CPAP, severe OSA or severe chronic obstructive pulmonary disease (COPD).

Need to Evaluate for Comorbid Diagnoses

Treatment of insomnia should be initiated only after careful evaluation of the patient. Re-evaluate for comorbid conditions if insomnia fails to remit after 7 to 10 days of treatment. Worsening insomnia or new cognitive or behavioral abnormalities may be the result of an underlying psychiatric or medical disorder and can emerge during treatment with sleep-promoting drugs such as QUVIVIQ.

Most Common Adverse Reactions

The most common adverse reactions (reported in ≥ 5% of patients treated with QUVIVIQ and at an incidence ≥ placebo) were headache and somnolence or fatigue.

Drug Interactions

  • CYP3A4 Inhibitors: The recommended dose of QUVIVIQ is 25 mg when used with a moderate CYP3A4 inhibitor. Concomitant use of QUVIVIQ with a strong inhibitor of CYP3A4 is not recommended.
  • CYP3A4 Inducers: Concomitant use of QUVIVIQ with a strong or moderate inducer of CYP3A4 is not recommended.

Use in Specific Populations

Pregnancy and Lactation

There are no available data on QUVIVIQ use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to QUVIVIQ during pregnancy. Pregnant women exposed to QUVIVIQ and healthcare providers are encouraged to call Idorsia Pharmaceuticals at 1-833-400-9611.

There are no data on the presence of daridorexant in human milk, the effects on the breastfed infant, or the effects on milk production. Monitor infants exposed to QUVIVIQ through breastmilk for excessive sedation.

Geriatric Use

Because QUVIVIQ can increase somnolence and drowsiness, patients, particularly the elderly, are at higher risk of falls. No dosage adjustment is required in patients over the age of 65 years.

Hepatic Impairment

QUVIVIQ is not recommended in patients with severe hepatic impairment. Reduce the dose in patients with moderate hepatic impairment.

Drug Abuse and Dependence

  • QUVIVIQ is a Schedule IV controlled substance.
  • Because individuals with a history of abuse or addiction to alcohol or other drugs may be at increased risk for abuse and addiction to QUVIVIQ, follow such patients carefully.

Please see full Prescribing Information.


References: 1. QUVIVIQ™ (daridorexant) [prescribing information]. Radnor, PA: Idorsia Pharmaceuticals US Inc; 2022. 2. Mignot E, Mayleben D, Fietze I, et al. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. Lancet Neurol. 2022;21:125-139. 3. Hudgens S, Phillips-Beyer A, Newton L, et al. Development and validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Patient. 2021;14:249-268. 4. Data on file. Idorsia Pharmaceuticals.