Important Safety Information

Jump to Section:

Indication Contraindications Warnings Side Effects Clinical Data Medication Guide

What is VIVAYZIO^®?

VIVAYZIO^® (somniclarin sodium) is a prescription medicine used to treat moderate to severe chronic sleep inertia syndrome (CSIS) in adults.

Drug Facts

Generic Name: somniclarin sodium

Drug Class: Selective wake-transition receptor modulator (SWTRM)

Controlled Substance: Not a controlled substance

FDA Approval: March 2025

Who should not take VIVAYZIO^®?

Do not take VIVAYZIO if you:

Are allergic to somniclarin sodium or any of the ingredients in VIVAYZIO
Have severe hepatic impairment
Are currently taking monoamine oxidase inhibitors (MAOIs) or have taken an MAOI within the past 14 days
Have a history of moderate to severe heart disease, including a history of myocardial infarction or unstable angina
Have been diagnosed with a seizure disorder

What should I tell my doctor before taking VIVAYZIO^®?

Tell your doctor about all of your medical conditions, including if you:

Have liver or kidney problems
Have a history of depression or suicidal thoughts
Have low blood pressure
Are pregnant or plan to become pregnant. It is not known if VIVAYZIO will harm your unborn baby.
Are breastfeeding or plan to breastfeed. VIVAYZIO may pass into breast milk.

Drug Interactions

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Important Drug Interactions:

MAOIs: Contraindicated (see contraindications above)
Strong CYP2D6 inhibitors: May require dose adjustment
CNS depressants: Use with caution, may enhance sedative effects

What are the possible serious side effects of VIVAYZIO^®?

VIVAYZIO may cause serious side effects, including:

Abnormal changes in mood or behavior

VIVAYZIO may cause mood changes including agitation, aggression, irritability, and in rare cases, hallucinations during the wake-transition period. Call your doctor right away if you notice any changes in mood or behavior.

Cardiovascular events

Increases in resting heart rate of 5–12 bpm were observed in clinical trials. Patients with pre-existing cardiovascular conditions should be monitored.

Parasomnias

Some patients experienced complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake, with no memory of the event. Discontinue VIVAYZIO and contact your doctor immediately if this occurs.

Allergic reactions

Seek emergency medical attention if you experience swelling of the face, lips, tongue, or throat, difficulty breathing, or severe rash.

What are the common side effects of VIVAYZIO^®?

The most common side effects of VIVAYZIO in clinical studies included:

14%

Headache

11%

Dry mouth

8%

Nausea

7%

Vivid dreams

6%

Dizziness upon standing

5%

Upper respiratory tract infection

4%

Mild euphoria during first 10 minutes of wakefulness

3%

Unexplained sense of optimism

2%

Transient hyperosmia (heightened sense of smell)

2%

Spontaneous early waking on non-treatment days

These are not all the possible side effects of VIVAYZIO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

VIVAYZIO is not a controlled substance and is not known to be habit-forming.

Clinical Data

The efficacy and safety of VIVAYZIO was established in the SUNRISE clinical development program.

SUNRISE-1 (Pivotal Efficacy Trial)

Study Design

24-week, randomized, double-blind, placebo-controlled
N = 1,247 (VIVAYZIO 15 mg: 623; Placebo: 624)
Adults with moderate to severe CSIS

Primary Endpoint Results

VIVAYZIO 15 mg

-17.4

Change from baseline in WOCD score at Week 12

vs.

Placebo

-9.8

Change from baseline in WOCD score at Week 12

p<0.001 (statistically significant)

SUNRISE-2 (Long-Term Extension Study)

52

weeks

892

completers

76

weeks efficacy maintained

Key Finding: No evidence of tachyphylaxis or dose escalation observed through 76 weeks of treatment.

SUNRISE-3 (Safety Study)

Study Duration: 52 weeks

Sample Size: N = 1,180 patients

Discontinuation due to AEs: 4.2% (VIVAYZIO) vs. 3.1% (placebo)

QTc Prolongation: No clinically significant prolongation observed

Abuse Potential: No evidence of abuse potential or withdrawal syndrome

Medication Guide

VIVAYZIO^® (somniclarin sodium) tablets

Read this Medication Guide before you start taking VIVAYZIO and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about VIVAYZIO?

VIVAYZIO may cause serious side effects including changes in mood or behavior
Some people taking VIVAYZIO have done activities while not fully awake that they do not remember
Tell your doctor right away if you experience any unusual changes in mood, behavior, or sleep patterns

How should I take VIVAYZIO?

Take exactly as prescribed by your doctor
Take once daily at bedtime, approximately 8 hours before your desired wake time
Can be taken with or without food
Swallow whole. Do not crush, chew, or split
If you miss a dose, skip it and take your next dose at the regular time

What should I avoid while taking VIVAYZIO?

Do not drink alcohol or take other medicines that make you sleepy
Do not drive or operate machinery if you feel drowsy
Avoid activities that require full alertness until you know how VIVAYZIO affects you

Please see full Prescribing Information, including Patient Information.

Download Full Prescribing Information (PDF) Download Patient Information (PDF)

Questions About VIVAYZIO^® Safety?

If you have questions about VIVAYZIO or experience any side effects, contact your healthcare provider or call our medical information line.

Medical Information

1-833-WAKEUP1 (1-833-925-3871)

Monday–Friday, 8 AM–8 PM ET

Report Side Effects

FDA: 1-800-FDA-1088

Elara Therapeutics: 1-833-925-3871