Introduction
LUNESTA, also known as eszopiclone, is a non-benzodiazepine hypnotic agent used for the treatment of insomnia. It has been on the market since 2005 and has undergone extensive clinical trials to establish its efficacy and safety profile.
Clinical Trials and Efficacy
Primary Insomnia Studies
Clinical trials conducted in Japan and overseas have demonstrated the effectiveness of LUNESTA in treating primary insomnia. In a Phase II/III study (Study 126) in Japan, LUNESTA significantly improved sleep latency (SL) and reduced latency to persistent sleep (LPS) compared to placebo, as measured by overnight polysomnography (PSG)[1].
Long-Term Studies
Long-term studies, such as Study 150, have confirmed the favorable safety profile of LUNESTA in patients with various forms of insomnia, including elderly adults and those with insomnia associated with psychological disorders. These studies showed that LUNESTA can be used over the long term without patients developing a tolerance to it[1].
FDA-Approved Studies
The FDA-approved label for LUNESTA is based on clinical trials that were up to 6 months in duration. These trials demonstrated that LUNESTA decreases sleep latency and improves sleep maintenance in both adults and elderly patients[3].
Safety Profile and Adverse Reactions
Warnings and Precautions
LUNESTA carries warnings for complex sleep behaviors and CNS depressant effects, including next-day impairment. Patients have reported engaging in activities while not fully awake, which can result in serious injuries or death. The FDA has emphasized the importance of using the lowest effective dose to minimize these risks[3][4].
Adverse Reactions
Common adverse reactions include dry mouth, dizziness, hallucinations, and unpleasant taste. The incidence of these reactions varies by dose and patient population. For example, in nonelderly adults, the most common adverse reactions at doses of 2 or 3 mg included viral infection, dry mouth, and dizziness[3].
Market Analysis
Market Trends
The insomnia treatment market experienced a significant decline from 2013 to 2016, primarily due to the generic erosion of LUNESTA in the United States. LUNESTA was the highest-selling insomnia treatment in 2013, but its sales plummeted due to generic competition, resulting in a negative compound annual growth rate (CAGR) of 16.7% over the forecast period[2].
Recovery and New Entrants
Despite the initial decline, the market is expected to recover by 2023, driven by the launch of new products such as Merck & Co’s Belsomra and Eisai’s E-2006. Belsomra, in particular, is forecast to become the market leader by 2023 due to its novel mechanism of action and evidence of long-term safety[2].
Market Projections
Sales Forecast
By 2023, the insomnia treatment market is projected to recover to $1.8 billion, up from $1.4 billion in 2016. LUNESTA, however, is expected to generate significantly lower sales, approximately $99.6 million across the seven major markets, compared to its peak in 2013[2].
Market Share
Belsomra is anticipated to dominate the market by 2023, generating sales of approximately $458.6 million. This shift reflects the market's preference for newer drugs with improved safety profiles and novel mechanisms of action[2].
Regulatory Updates
FDA Dose Adjustments
In response to safety concerns about lingering drowsiness, the FDA has lowered the recommended starting dose of LUNESTA to 1 mg at bedtime. This decision, similar to the one made for Ambien (zolpidem) in 2013, aims to minimize next-day impairment, particularly in driving skills, memory, and coordination[4][5].
Key Takeaways
- Efficacy: LUNESTA has been proven effective in treating transient and chronic insomnia, improving sleep latency and maintenance.
- Safety: The drug carries warnings for complex sleep behaviors and CNS depressant effects, necessitating careful dose management.
- Market Trends: The insomnia treatment market declined due to generic erosion of LUNESTA but is expected to recover with new product launches.
- Projections: Belsomra is forecast to become the market leader by 2023, while LUNESTA sales will continue to decline.
- Regulatory Updates: The FDA has reduced the recommended starting dose of LUNESTA to 1 mg to mitigate next-day impairment.
FAQs
What is LUNESTA used for?
LUNESTA is used for the treatment of insomnia, specifically to decrease sleep latency and improve sleep maintenance[3].
What are the common adverse reactions of LUNESTA?
Common adverse reactions include dry mouth, dizziness, hallucinations, and unpleasant taste. The incidence of these reactions can vary by dose and patient population[3].
Why did the FDA lower the starting dose of LUNESTA?
The FDA lowered the starting dose to 1 mg to minimize next-day impairment, particularly in driving skills, memory, and coordination, due to lingering drowsiness[4][5].
What is the market outlook for LUNESTA?
The market for LUNESTA is expected to decline further due to generic competition, while new drugs like Belsomra are projected to dominate the market by 2023[2].
Can LUNESTA be used long-term without developing tolerance?
Yes, clinical trials have shown that LUNESTA can be used over the long term without patients developing a tolerance to it[1].
What are the recommended dosages for LUNESTA?
The recommended starting dose is 1 mg, which can be increased to 2 mg or 3 mg if clinically indicated. However, older adults should not take doses exceeding 2 mg[3][4].
Sources
- Eisai: EISAI RECEIVES APPROVAL TO MARKET INSOMNIA TREATMENT LUNESTA IN JAPAN.
- Sleep Review Magazine: Insomnia Treatment Market Faces Steep Decline to 2016, But New Drugs Will Aid Recovery.
- FDA: LUNESTA® (eszopiclone) tablets.
- American Academy of Sleep Medicine: FDA lowers starting dose for sleeping pill Lunesta.
- FDA: FDA Drug Safety Communication: FDA warns of next-day impairment with sleep aid Lunesta (eszopiclone) and lowers.
