The first study evaluated the effect of Lunesta (eszopiclone) 3mg compared to placebo in patients with rheumatoid arthritis (RA) and co-existing insomnia. In this pilot study, nightly use of Lunesta resulted in statistically significant improvement from baseline compared with placebo in patient-reported measures of sleep latency, wake time after sleep onset (WASO), total sleep time and sleep quality, for each week of the four-week study.
Compared to placebo, patients administered Lunesta also reported improvements on the insomnia severity index (ISI), including total score and on the extended ISI items of sleep quality, feeling refreshed/rested, daytime fatigue and relationship enjoyment measured at week four.
Assessments of RA symptoms with a number of instruments were also conducted in this study. Compared to baseline, patients administered Lunesta reported improvement as measured by various scales at week four versus those patients administered placebo. The outcomes observed on RA symptom scores are interpreted as resulting from the effects on sleep.
The second study for which data were presented was designed to evaluate Lunesta treatment during menopausal transition, looking at sleep effects, impact on menopausal symptoms and mood.
In this phase study, nightly use of Lunesta 3mg resulted in statistically significant improvement from baseline compared with placebo in patient-reported measures of sleep latency, WASO and total sleep time for each week of the four-week, double-blind treatment period. Patients treated with Lunesta also demonstrated significant improvements in additional insomnia measures, including sleep quality, sleep depth, daytime alertness, ability to function, ability to think and concentrate clearly, and sense of well-being, versus those patients administered placebo.
Compared to baseline and averaged over the double-blind period, women treated with Lunesta reported fewer total nocturnal awakenings and fewer awakenings due to hot flashes compared to those patients administered placebo. Other findings include improvements from baseline in perimenopausal symptoms.
The study also assessed changes in total sleep time, sleep latency and sleep maintenance in the seven days following patients’ discontinuation of Lunesta treatment. The Lunesta treatment group did not experience rebound insomnia after discontinuation of Lunesta.
The outcomes observed in this study on menopausal symptom scores are also interpreted as resulting from the effects on sleep.