On the basis of two published clinical trials (see “Clinical Efficacy” on page 389), the most commonly reported adverse drug event (ADE) was an unpleasant taste, with an incidence of 17% to 26%, with no dose-dependent relationship. Somnolence was reported equally at all doses, with an incidence of 4% to 9%. However, headache was reported with the same frequency as placebo in both trials (9°% and 19°%).
The incidence of dizziness was greater than 5% in both trials. In the clinical trial by Krystal et al., dry mouth (6.6%), infection (15.9%), nausea (11.3%), pain (11.3%), and pharyngitis (9.9%) were all reported at a higher frequency with the study drug than with placebo.
No clinically significant laboratory, cardiovascular, or electrocardiographic changes were reported in these studies, and there were no significant withdrawal symptoms upon discontinuation of the drug.
Eszopiclone is a schedule IV drug indicated for the treatment of insomnia in adults (at least 18 years of age). There are no contraindications to the use of eszopiclone other than a known hyper-sensitivity to eszopiclone, zopiclone, or any of its components.
The recommended dose for non-elderly adults is 2 mg at bedtime, to be increased to 3 mg if needed. Zammit et al. compared placebo, eszopiclone 2 mg, and eszopiclone 3 mg in adults younger than 65 years of age. The 2-mg and 3-mg dosages were found to be equally efficacious in reducing sleep latency. The 3-mg strength provided a higher median total sleep time of 406 minutes, whereas 2 mg provided 400 minutes. canadian pharmacy viagra
In a trial comparing eszopiclone 1, 2, 3, and 3.5 mg with placebo, all doses were found to be equally efficacious in reducing sleep latency; however, total sleep time was slightly increased across the dosage range (see “Clinical Efficacy”). In general, however, treatment should be individualized for each patient.
A starting dose of 1 mg is recommended for older adults whose primary complaint is difficulty falling asleep. This dose can be increased to 2 mg if needed. If the main complaint is difficulty staying asleep, eszopiclone can be initiated at 2 mg at bedtime.
The AUC concentration was increased by 41% in elderly patients when compared with non-elderly adults. In one clinical trial comparing eszopiclone 1 mg and 2 mg in elderly patients, both dosages were found to be superior to placebo in terms of sleep onset and total sleep time. Both dosages were also well tolerated.
Hepatically Impaired Patients
Eszopiclone should be used with caution in patients with severe hepatic impairment; in these patients, systemic exposure increased by 74%. The package insert recommends a starting dose of 1 mg. No dose adjustment appears to be necessary in patients with mild-to-moderate hepatic impairment.
Patients with Renal Impairment
No dosage adjustment is indicated for patients with renal impairment, but systemic exposure to the drug increased by 29% to 47% in patients with severe renal impairment. Patients with renal impairment should be closely monitored for side effects or excessive sedation.
Pregnant and Lactating Patients
Eszopiclone is categorized as a pregnancy category C drug. No studies have been conducted with eszopiclone in pregnant women or nursing mothers. It is not known whether eszopiclone is excreted in human milk. The potential risks and benefits of using eszopiclone should be considered before it is prescribed during pregnancy or lactation.