Insomnia affects >50 million Americans, according to the National Institutes of Health. Symptoms of insomnia include difficulty in falling asleep, frequent awakening during the night, early awakening, inability or difficulty in falling back to sleep, or waking up feeling unrefreshed.
A 2003 National Sleep Foundation Sleep in America poll found that 37 million older Americans suffer from frequent sleep problems that could complicate the treatment of other medical conditions, such as arthritis, diabetes, or heart and lung disease. This poll also showed that poor sleep goes unnoticed among older adults. Lunesta (eszopiclone), manufactured by Sepracor, has received approval from the FDA for the treatment of transient and chronic insomnia.1
Eszopiclone is a cyclopyrrolone that acts on the GABA receptor complex, but at a different site than benzodiazepines. Its onset of action is ~30 minutes, with a duration of action of ~5 to 7 hours.
Sepracor submitted a total of 25 clinical trials to the FDA for review, which included >2700 adult and elderly subjects. One 6-month, phase 3, randomized, double-blind, placebo-controlled study was published in the journal Sleep in November 2003.2 This study included 788 chronic insomnia patients 21 to 69 years of age. Patients were given either a placebo or 3 mg eszopiclone. Nightly use of eszopiclone 3 mg resulted in statistically significant improvement in sleep onset, maintenance, and quality, as well as improved daytime alertness and functioning and an improved sense of well-being, versus placebo. Improvements were seen in the first week of treatment and were maintained throughout 6 months of double-blind treatment, with no decline in efficacy (no tolerance developed).
A 6-week, phase 3, randomized, double- blind, multicenter, placebo-controlled study involved adult patients aged 21 to 64 years.3 Patients were treated with eszopiclone 2 or 3 mg or placebo and were assessed after the first dose and at 2, 4, and 6 weeks for efficacy and potential for rebound insomnia. Patients treated with either dose of eszopiclone demonstrated a significant improvement in latency to persistent sleep, sleep latency, sleep onset, sleep efficiency, total sleep time, and sleep quality and depth, versus placebo. Eszopiclone 3 mg significantly improved objective and subjective wake time after sleep onset, versus placebo. Efficacy did not decline over 6 weeks, and no rebound was observed on sleep-onset or sleep-maintenance parameters upon eszopiclone discontinuation. In addition, no apparent adverse events were associated with withdrawal when patients ended eszopiclone treatment.
A phase 3, multicenter, randomized, double-blind, placebo-controlled study was conducted with 231 elderly patients.4 Patients were given either eszopiclone 2 mg or a placebo for 14 nights. Eszopiclone 2 mg significantly improved sleep onset, wake time after sleep onset, total sleep time, and sleep quality and depth, compared with placebo. Patients also were evaluated for daytime napping, which is associated with a considerably increased health risk. Eszopiclone 2 mg significantly reduced the number and duration of daytime naps over the treatment period. In addition, eszopiclone-treated patients reported significantly improved daytime alertness and sense of physical well-being. Eszopiclone was well tolerated, with headache (15%) and daytime somnolence (4%) the most common side effects. Research is continuing on the efficacy of eszopiclone in patients with insomnia and other disease states, such as depression, rheumatoid arthritis, and perimenopause.
Eszopiclone's acceptable side-effect profile and effectiveness are similar to those of other available sleep aids and are supported by 6 months of clinical trials. As the only nonbenzodiazepine studied for this long, eszopiclone shows promise for patients with chronic and transient insomnia, including elderly patients.
Dr. Holmberg is a pharmacist with Phoenix Children's Hospital, Phoenix, Ariz. Dr. Schott is a pharmacist with Stop and Shop, Wallingford, Conn.
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