The information contained in this section is intended for U.S. healthcare professionals only. By clicking "I am a U.S. Healthcare Professional" below, you are certifying that you are a licensed healthcare professional authorized to prescribe medications in the United States.
VIVAYZIO® (somniclarin sodium) is the first selective wake-transition receptor modulator (SWTRM) indicated for the treatment of moderate to severe chronic sleep inertia syndrome (CSIS) in adults.
Approval was based on data from the SUNRISE clinical development program, which included over 3,200 patients across three Phase 3 trials.
p<0.001 vs. placebo. Intent-to-treat population. MMRM analysis.
| Adverse Event | VIVAYZIO 15 mg (n=590) |
Placebo (n=590) |
|---|---|---|
| Headache | 14.2% | 11.8% |
| Dry mouth | 11.0% | 4.2% |
| Nausea | 8.1% | 5.4% |
| Vivid dreams | 7.3% | 2.1% |
| Dizziness upon standing | 6.1% | 3.9% |
| Upper respiratory tract infection | 5.4% | 4.8% |
| Mild euphoria upon waking | 4.1% | 0.8% |
| Unexplained sense of optimism | 3.2% | 1.0% |
| Transient hyperosmia | 2.0% | 0.3% |
| Discontinuation due to AEs | 4.2% | 3.1% |
For prior authorization assistance, coverage questions, or to connect with a field medical representative, call:
1-833-WAKEUP1 (1-833-925-3871)
Monday–Friday, 8 AM–8 PM ET