An opportunity to say goodnight insomnia, hello tomorrow

QUVIVIQ 50 mg efficacy across both night & day

When taken every night, QUVIVIQ continued to improve sleep over time^1*

Nighttime

Statistically significant nighttime improvements vs placebo¹

Increase total sleep time (sTST)

Daytime

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

QUVIVIQ 50 mg reduced daytime sleepiness²

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

IDSIQ sleepiness domain evaluated mental tiredness, physical tiredness, energy, and sleepiness³

Comprehensive clinical trial program assessed the impact of QUVIVIQ on both night & day endpoints^1,2

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 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

Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ)^2,3

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

*Improvements measured at Months 1 and 3.

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

Individual results may vary.

Getting more sleep helps me to be ready for whatever my day brings.”

Lindsey Vonn

Insomnia sufferer and QUVIVIQ patient

Explore her insomnia story

Nighttime

When taken every night, 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

50 mg 25 mg

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).¹

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 min [-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 min [-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 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

50 mg 25 mg

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.

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).¹

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 helps patients

Gain more total sleep time¹

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

Subjective total sleep time (sTST), patient-reported

50 mg 25 mg

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.

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).¹

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.

When QUVIVIQ was taken every night, patients saw improvements at Week 1 that continued to build over 3 to 4 weeks^1＊

*Based on sTST data.

Daytime

When 50 mg QUVIVIQ 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 (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.

When 50 mg QUVIVIQ was taken every night,

Reductions in daytime sleepiness were reported at Week 1 and continued to improve over time^2,4-5

Reduced daytime sleepiness compared with placebo (Study 1)

Improvements in IDSIQ sleepiness domain score, patient-reported

Untreated Insomnia

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

See the safety profile of once-nightly QUVIVIQ

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Idorsia Medical Information

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 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.

An opportunity to say goodnight insomnia, hello tomorrow

Fall asleep faster (LPS)

Stay asleep longer (WASO)

Increase total sleep time (sTST)

QUVIVIQ 50 mg reduced daytime sleepiness²

IDSIQ sleepiness domain evaluated mental tiredness, physical tiredness, energy, and sleepiness³

Nighttime

Daytime

Register for a QUVIVIQ educational program

Important Safety Information

Contraindications

Warnings and Precautions

INDICATION

INDICATION

Important Safety Information

Contraindications

Warnings and Precautions

Most Common Adverse Reactions

Drug Interactions

Use in Specific Populations

Drug Abuse and Dependence

An opportunity to say goodnight insomnia, hello tomorrow

Fall asleep faster (LPS)

Stay asleep longer (WASO)

Increase total sleep time (sTST)

QUVIVIQ 50 mg reduced daytime sleepiness2

IDSIQ sleepiness domain evaluated mental tiredness, physical tiredness, energy, and sleepiness3

Nighttime

Daytime

STAY IN THE KNOW

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Register for a QUVIVIQ educational program

Important Safety Information

Contraindications

Warnings and Precautions

INDICATION

INDICATION

Important Safety Information

Contraindications

Warnings and Precautions

Most Common Adverse Reactions

Drug Interactions

Use in Specific Populations

Drug Abuse and Dependence

QUVIVIQ 50 mg reduced daytime sleepiness²

IDSIQ sleepiness domain evaluated mental tiredness, physical tiredness, energy, and sleepiness³

Sign up to receive
updates on QUVIVIQ