Introduction
DAYVIGO, also known as lemborexant, is a novel orexin receptor antagonist approved by the US FDA for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Here, we delve into the clinical trials that led to its approval, its market analysis, and future projections.
Clinical Trials Overview
Phase 3 Studies: SUNRISE 1 and SUNRISE 2
The approval of DAYVIGO was based on two pivotal Phase 3 studies, SUNRISE 1 and SUNRISE 2. These studies evaluated the efficacy and safety of DAYVIGO in adult patients with insomnia disorder.
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SUNRISE 1: This was a one-month trial that compared DAYVIGO to placebo. The primary efficacy endpoint was the mean change in log-transformed latency to persistent sleep (LPS) from baseline to the end of treatment, measured by overnight polysomnography (PSG). DAYVIGO demonstrated a statistically significant reduction in LPS compared to placebo, with reductions of -11 minutes and -13 minutes for the 5 mg and 10 mg doses, respectively[2][4].
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SUNRISE 2: This was a six-month trial that also compared DAYVIGO to placebo. The study included a six-month safety extension period. Patients received either DAYVIGO 5 mg, DAYVIGO 10 mg, or placebo once nightly. The study showed significant improvements in sleep onset, sleep maintenance, and sleep efficiency compared to placebo. Notably, DAYVIGO did not lead to rebound insomnia or withdrawal effects upon discontinuation[2][4].
Long-Term Efficacy and Safety
Post-hoc analyses from these studies highlighted the long-term efficacy and safety of DAYVIGO. At six and twelve months, patients treated with DAYVIGO showed sustained improvements in sleep onset latency, sleep efficiency, and sleep maintenance. For example, at six months, the decrease in wake after sleep onset (sWASO) was greater with DAYVIGO compared to placebo, and these effects persisted at twelve months[1][3].
Special Populations
Additional analyses focused on specific patient populations, including adults aged 65 and older and women of perimenopausal age with insomnia disorder. These studies demonstrated that DAYVIGO was effective and safe in these groups, improving sleep parameters such as sleep onset latency and sleep efficiency[1][3].
Transition from Zolpidem
An open-label pilot study evaluated the transition from zolpidem to DAYVIGO. The study found that 81% of patients successfully transitioned to DAYVIGO after two weeks, with all patients who transitioned choosing to continue DAYVIGO in the extension phase. The safety profile during this transition was consistent with the known safety profile of DAYVIGO[3].
Market Analysis
Current Market
The insomnia therapeutics market is significant and growing. DAYVIGO, as a new entrant, is poised to capture a share of this market. The global insomnia therapeutics market was valued at USD 3.16 billion in 2024 and is expected to grow at a CAGR of 5.3% from 2025 to 2035, reaching USD 5.58 billion by 2035[5].
Regional Market
North America is currently the largest market for insomnia therapeutics, while the Asia Pacific region is expected to be the fastest-growing market. This growth is driven by increasing awareness of sleep disorders, an aging population, and the availability of new therapeutic options like DAYVIGO[5].
Competitive Landscape
DAYVIGO enters a market with existing treatments but offers unique advantages, such as its mechanism of action as an orexin receptor antagonist and its demonstrated long-term safety and efficacy. This differentiation could help DAYVIGO gain market share from traditional sleep aids like zolpidem[4].
Market Projections
Growth Drivers
Several factors are expected to drive the growth of DAYVIGO in the market:
- Increasing Prevalence of Insomnia: Insomnia is a chronic condition affecting a significant portion of the population, and its prevalence is expected to rise with an aging population.
- Long-Term Safety and Efficacy: DAYVIGO's unique profile, including its lack of rebound insomnia and withdrawal effects, positions it favorably in the market.
- Expanding Awareness: Growing awareness of sleep disorders and the importance of sleep health will drive demand for effective treatments like DAYVIGO[4][5].
Market Share
Given its strong clinical trial data and the growing demand for insomnia treatments, DAYVIGO is expected to capture a substantial share of the insomnia therapeutics market. Its ability to improve both sleep onset and sleep maintenance, along with its safety profile, makes it an attractive option for patients and healthcare providers alike.
Key Takeaways
- Clinical Efficacy: DAYVIGO has demonstrated significant improvements in sleep onset, sleep maintenance, and sleep efficiency in clinical trials.
- Long-Term Safety: The drug has shown sustained efficacy and safety over six and twelve months without rebound insomnia or withdrawal effects.
- Market Potential: DAYVIGO is expected to grow significantly in the insomnia therapeutics market, driven by its unique mechanism of action and favorable safety profile.
- Regional Growth: North America is the largest current market, while the Asia Pacific region is expected to be the fastest-growing.
FAQs
Q: What is DAYVIGO, and how does it work?
A: DAYVIGO (lemborexant) is an orexin receptor antagonist that works by blocking the action of orexins, which are chemicals in the brain that regulate wakefulness. This helps patients fall asleep and stay asleep.
Q: What were the key findings from the Phase 3 clinical trials of DAYVIGO?
A: The Phase 3 trials showed that DAYVIGO significantly reduced latency to persistent sleep, improved sleep efficiency, and enhanced sleep maintenance compared to placebo, with these effects sustained over six and twelve months.
Q: Is DAYVIGO safe for long-term use?
A: Yes, DAYVIGO has been shown to be safe for long-term use, with no evidence of rebound insomnia or withdrawal effects upon discontinuation.
Q: Can patients transition from zolpidem to DAYVIGO?
A: Yes, an open-label pilot study demonstrated that patients can successfully transition from zolpidem to DAYVIGO, with a high rate of patients choosing to continue DAYVIGO after the transition period.
Q: What is the projected market size for insomnia therapeutics by 2035?
A: The global insomnia therapeutics market is expected to reach USD 5.58 billion by 2035, growing at a CAGR of 5.3% from 2025 to 2035.
Sources
- Eisai Inc. - Eisai Presents New Analyses from Phase 3 Studies of DAYVIGO™ from the Phase 3 SUNRISE 1 and 2 clinical studies and top-line results from an open label pilot study.
- Health Canada - Summary Basis of Decision for Dayvigo.
- PR Newswire - Eisai Presents New Analyses from Phase 3 Studies of DAYVIGO™ for the Treatment of Insomnia in Adult Patients at Virtual SLEEP 2020.
- Respiratory Therapy - FDA Approves Dayvigo/Lemborexant for Insomnia.
- MetaTech Insights - Insomnia Therapeutics Market Share, Size, Growth 2025-2035.
