From the FDA Drug Label
The pharmacokinetics of eszopiclone were studied in 24 patients with mild, moderate, or severe renal impairment. AUC and Cmax were similar in the patients compared with demographically matched healthy control subjects No dose adjustment is necessary in patients with renal impairment, since less than 10% of the orally administered eszopiclone dose is excreted in the urine as parent drug.
Zopiclone Safety in Patients with Impaired Renal Function:
- The pharmacokinetics of eszopiclone (the S-isomer of racemic zopiclone) were similar in patients with mild, moderate, or severe renal impairment compared to healthy control subjects.
- No dose adjustment is necessary in patients with renal impairment.
- Key Point: Zopiclone is likely safe in patients with impaired renal function, including those on dialysis, as less than 10% of the dose is excreted in the urine as parent drug 1.
From the Research
Zopiclone should be used with caution in dialysis patients, with a recommended dose reduction of 50% (typically 3.75 mg instead of 7.5 mg) at bedtime due to decreased drug clearance in renal failure. This is because zopiclone is primarily metabolized by the liver, but about 50% is excreted by the kidneys, which can lead to drug accumulation in patients on dialysis 2. The accumulation of zopiclone may cause prolonged sedation, increased risk of falls, cognitive impairment, and respiratory depression. Dialysis itself does not effectively remove zopiclone from the bloodstream.
Some key points to consider when prescribing zopiclone to dialysis patients include:
- Close monitoring for side effects is essential if zopiclone is prescribed, and the medication should be used for the shortest duration possible to minimize risks of dependence and adverse effects.
- For dialysis patients requiring sleep medication, shorter-acting alternatives like temazepam might be preferable, or non-pharmacological approaches such as sleep hygiene practices should be considered first.
- The pharmacokinetics of zopiclone in patients with impaired renal function have been studied, and the results suggest that zopiclone may be safely used in patients with various degrees of renal impairment, but with caution and dose adjustment as needed 2.
- Other studies have highlighted the importance of considering the risks and benefits of hypnotic medications in patients with renal impairment, and the need for careful monitoring and dose adjustment to minimize the risk of adverse effects 3, 4.
Overall, the use of zopiclone in dialysis patients requires careful consideration of the potential risks and benefits, and close monitoring for side effects to minimize the risk of adverse effects.