Maximum Recommended Dose of Zopiclone
The highest recommended dose of zopiclone is 7.5 mg for adults under 65 years, with a reduced maximum of 3.75–5.0 mg for elderly patients (≥65 years), patients with hepatic impairment, or those particularly sensitive to sedatives. 1, 2, 3
Standard Adult Dosing (Ages 18–64)
The optimal therapeutic dose for non-elderly adults is 7.5 mg taken at bedtime, which has demonstrated hypnotic efficacy comparable to flurazepam 30 mg, nitrazepam 5 mg, and triazolam 0.25–0.5 mg in controlled trials. 1, 4
Doses of 10 mg have been studied but offer minimal additional benefit over 7.5 mg, with only slight differences in sleep quantity and quality, making 7.5 mg the preferred maximum for routine use. 2, 3
Zopiclone should be taken immediately before bedtime with at least 7–8 hours available for sleep, as its elimination half-life is approximately 5–6 hours in healthy adults. 1, 5
Elderly Patients (≥65 Years)
The starting and maximum dose for elderly patients is 7.5 mg, though many geriatric studies suggest 3.75–5.0 mg may be optimal due to age-related pharmacokinetic changes. 2, 3
In geriatric patients (mean age 81 years), all doses from 3.75 mg to 10 mg improved sleep compared to placebo, but 7.5 mg was identified as the best dose balancing efficacy and tolerability. 2
Elderly patients show prolonged elimination (half-life approximately 9 hours vs. 6 hours in younger adults), increasing the risk of next-day sedation and falls at higher doses. 5
Doses above 7.5 mg are not recommended in elderly patients due to increased sensitivity and minimal additional therapeutic benefit. 2, 3
Hepatic Impairment
Patients with severe hepatic impairment should not exceed 3.75 mg (half the standard adult dose), as drug clearance is significantly reduced. 6
Mild-to-moderate hepatic impairment does not require dose adjustment, but caution is advised and the maximum dose should remain 7.5 mg. 6
Patients Sensitive to Sedatives
For patients particularly sensitive to sedative effects, initiate at 3.75 mg and do not exceed 5.0 mg, as lower doses have demonstrated efficacy in controlled trials with better tolerability. 2, 3
Zopiclone causes minimal impairment to psychomotor performance at therapeutic doses (3.75–7.5 mg), but sensitive individuals may experience residual morning sedation at higher doses. 1, 2
Duration of Treatment
Zopiclone is indicated for short-term use only and should not be prescribed for more than 4 weeks, as tolerance, dependence, and withdrawal reactions can occur with prolonged administration. 4
Clinical trials have not demonstrated significant rebound insomnia or withdrawal reactions when zopiclone is discontinued after short-term use at therapeutic doses. 1, 4
Critical Safety Warnings
Doses above 7.5 mg (or 3.75–5.0 mg in elderly/hepatic impairment) are not recommended due to lack of additional efficacy and increased risk of adverse effects including bitter taste, dry mouth, daytime sedation, and psychomotor impairment. 1, 2, 3
Patients with a history of substance abuse should be monitored closely, as isolated reports of physical dependence have occurred, though zopiclone appears to have low dependence liability at therapeutic doses. 1, 4
Avoid combining zopiclone with alcohol or other CNS depressants, as this markedly increases the risk of respiratory depression and complex sleep behaviors. 6, 5
Common Pitfalls to Avoid
Prescribing 10 mg doses routinely when 7.5 mg provides equivalent efficacy with better tolerability. 2, 3
Failing to reduce the dose to 3.75–5.0 mg in elderly patients or those with hepatic impairment, leading to excessive sedation and fall risk. 2, 3
Continuing zopiclone beyond 4 weeks without reassessment, increasing the risk of tolerance and dependence. 4
Using adult dosing (7.5 mg) in elderly patients without considering age-related pharmacokinetic changes that prolong drug elimination. 5