We might be gaining daylight, but patients are still losing sleep

Sleep Awareness Week and daylight savings are this month, making it even more important to have a conversation about sleep with your patients, and QUVIVIQ may help.1 QUVIVIQ is initiated differently, 50 mg every night,† so patients can be proactive about their sleep health.1 It is experienced differently leading to better sleep over time.1*

*Improvements measured at Months 1 and 3. †Recommended dosage of QUVIVIQ for patients with moderate hepatic impairment or those who are taking moderate CYP3A4 inhibitors is 25 mg no more than once per night.
Reference: 1. QUVIVIQ® (daridorexant) [prescribing information]. Radnor, PA: Idorsia Pharmaceuticals US Inc; 2024.

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QUVIVIQ 50 mg nightly
improved sleep for
patients with insomnia1

A prescription insomnia treatment, QUVIVIQ is
used to treat sleep impairment

When taken every night, QUVIVIQ continued to improve sleep over time1*

QUVIVIQ helped improve both daytime & nighttime symptoms of insomnia1,2

*Improvements measured at Months 1 and 3.

Statistically significant nighttime improvements with QUVIVIQ 50 mg vs placebo1

Latency to persistent sleep (LPS) and wake after sleep onset (WASO) were assessed objectively by polysomnography.
Subjective total sleep time (sTST) was patient reported.

When taken every night,

QUVIVIQ 50 mg helps patients fall asleep faster1

Greatest efficacy was seen with QUVIVIQ 50 mg compared to placebo

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.

Study 2 data

In Study 2, mean baseline LPS was 69 minutes for QUVIVIQ 25 mg (n=309) and 72 minutes for placebo (n=308).

STUDY 2 Month 1 Month 3
Placebo 25 mg Placebo 25 mg
Mean LPS 50 min 42 min 49 min 39 min
Change from
baseline LSM
(95% CL)		 -20
[-24, -16]		 -26
[-31, -22]		 -20
[-24, -15]		 -29
[-33, -24]
Difference to
placebo LSM
(95% CL)		 -6
[-12, -1]		 -9
[-15, -3]
STUDY 2 Month 1
Placebo 25 mg
Mean LPS 50 min 42 min
Change from
baseline LSM
(95% CL)		 -20
[-24, -16]		 -26
[-31, -22]
Difference to
placebo LSM
(95% CL)		 -6
[-12, -1]
STUDY 2 Month 3
Placebo 25 mg
Mean LPS 49 min 39 min
Change from
baseline LSM
(95% CL)		 -20
[-24, -15]		 -29
[-33, -24]
Difference to
placebo LSM
(95% CL)		 -9
[-15, -3]

LPS reductions for QUVIVIQ 25 mg were not significant at Months 1 or 3 in Study 2.

When taken every night,

QUVIVIQ 50 mg helps patients spend more time asleep after onset

vs placebo and QUVIVIQ 25 mg1

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 significantly superior (p<0.05) to placebo after controlling for multiple comparisons.

CL, confidence limit; LSM, least squares mean.

Study 2 data

In Study 2, mean baseline WASO was 106 minutes for QUVIVIQ 25 mg (n=309) and 108 minutes for placebo (n=308).

STUDY 2 Month 1 Month 3
Placebo 25 mg Placebo 25 mg
Mean WASO 93 min 80 min 91 min 80 min
Change from
baseline LSM
(95% CL)		 -13
[-17, -8]		 -24
[-28, -20]		 -14
[-19, -9]		 -24
[-29, -19]
Difference to
placebo LSM
(95% CL)		 -12*
[-18, -6]		 -10*
[-17, -4]
STUDY 2 Month 1
Placebo 25 mg
Mean WASO 93 min 80 min
Change from
baseline LSM
(95% CL)		 -13
[-17, -8]		 -24
[-28, -20]
Difference to
placebo LSM
(95% CL)		 -12*
[-18, -6]
STUDY 2 Month 3
Placebo 25 mg
Mean WASO 91 min 80 min
Change from
baseline LSM
(95% CL)		 -14
[-19, -9]		 -24
[-29, -19]
Difference to
placebo LSM
(95% CL)		 -10*
[-17, -4]

*Doses that were statistically significantly superior (p<0.05) to placebo after controlling for multiple comparisons.

CL, confidence limit; LSM, least squares mean.

When taken every night,

QUVIVIQ 50 mg helps patients gain more total sleep time

vs placebo and QUVIVIQ 25 mg1

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 significantly superior (p<0.05) to placebo after controlling for multiple comparisons.

CL, confidence limit; LSM, least squares mean.

Study 2 data

In Study 2, mean baseline sTST was 308 minutes for QUVIVIQ 25 mg (n=309) and 308 minutes for placebo (n=308).

STUDY 2 Month 1 Month 3
Placebo 25 mg Placebo 25 mg
Mean sTST 336 min 353 min 347 min 365 min
Change from
baseline LSM
(95% CL)		 28
[22, 33]		 44
[38, 49]		 37
[31, 43]		 56
[50, 63]
Difference to
placebo LSM
(95% CL)		 16*
[8, 24]		 19*
[10, 28]
STUDY 2 Month 1
Placebo 25 mg
Mean sTST 336 min 353 min
Change from
baseline LSM
(95% CL)		 28
[22, 33]		 44
[38, 49]
Difference to
placebo LSM
(95% CL)		 16*
[8, 24]
STUDY 2 Month 3
Placebo 25 mg
Mean sTST 347 min 365 min
Change from
baseline LSM
(95% CL)		 37
[31, 43]		 56
[50, 63]
Difference to
placebo LSM
(95% CL)		 19*
[10, 28]

*Doses that were statistically significantly superior (p<0.05) to placebo after controlling for multiple comparisons.

CL, confidence limit; LSM, least squares mean.

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

Patient-reported IDSIQ sleepiness domain score in a Study 1 secondary endpoint (25 mg did not reach significance in either Study 1 or 2).

Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) sleepiness domain evaluated mental tiredness, physical tiredness, energy, and sleepiness and was the first patient-reported outcome tool developed and validated according to FDA guidelines that can evaluate daytime symptoms in patients with insomnia2,3

When QUVIVIQ 50 mg was taken every night,

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

  • 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 50 mg Placebo 50 mg
Change from
baseline LSM
(95% CL)		 -2.0
[-2.6, -1.5]		 -3.8
[-4.3, -3.2]		 -3.8
[-4.5, -3.1]		 -5.7
[-6.4, -5.0]
Difference to
placebo LSM
(95% CL)		 -1.8*
[-2.5, -1.0]		 1.9†
[-2.9, -0.9]
STUDY 1 Month 1
Placebo 50 mg
Change from
baseline LSM
(95% CL)		 -2.0
[-2.6, -1.5]		 -3.8
[-4.3, -3.2]
Difference to
placebo LSM
(95% CL)		 -1.8*
[-2.5, -1.0]
STUDY 1 Month 3
Placebo 50 mg
Change from
baseline LSM
(95% CL)		 -3.8
[-4.5, -3.1]		 -5.7
[-6.4, -5.0]
Difference to
placebo LSM
(95% CL)		 1.9†
[-2.9, -0.9]

*p<0.0001.

†p=0.0002.

CL, confidence limit; LSM, least squares mean.

When QUVIVIQ 50 mg was taken every night,

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

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

Improvements in IDSIQ sleepiness domain score, patient-reported

  • 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

Comprehensive clinical trial program assessed the impact of QUVIVIQ on both night & day endpoints1,2

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

Primary efficacy endpoints:

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

  • Latency to persistent sleep (LPS)
  • Wake after sleep onset (WASO)

Secondary efficacy endpoints:

  • Patient-reported subjective 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

Hear what your colleagues have to say about daytime sleepiness

HOSTED BY

Paul Doghramji, MD, FAAFP
Gary Zammit, PhD
Leslie Citrome, MD, MPH

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Ron B.
QUVIVIQ 50 mg patient, insomnia sufferer

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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.
  • in patients with a history of hypersensitivity to daridorexant or any components of QUVIVIQ.

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 sleepwalking, 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

QUVIVIQ has been studied in mild to severe OSA not using CPAP, and in patients with moderate COPD. The effects of QUVIVIQ on respiratory function should be considered if prescribed to patients with compromised respiratory function. QUVIVIQ has not been studied in patients with mild or severe 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.

Daridorexant is present in human breast milk in low amounts. There are no data on the effects of daridorexant on the breastfed infant or its effects on milk production. Infants exposed to QUVIVIQ through breastmilk should be monitored 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; 2024.

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. CSR 303. Idorsia. 2022.