【藥品性質提示】 根據 2019 AGS Beers Criteria，本藥品為【潛在不適當用藥 (PIM)】，不建議用於老年人。

(United States: Not available)
Insomnia, chronic; Transient insomnia

1. Zopiclone is a non-benzodiazepine hypnotic agent. This drug is a cyclopyrrolone derivative, unrelated chemically to the benzodiazepines, and was developed in an attempt to overcome problems associated with benzodiazepine hypnotic agents, particularly dependence and residual daytime sedation.
2. Pharmacologic effects of zopiclone are related to its binding to sites on the benzodiazepine receptor complex and facilitation of GABA function. However, it does not appear to bind to sites corresponding exactly to benzodiazepine sites, but rather to sites close by on the receptor complex. Enhanced binding of GABA to the GABA-chloride ionophore complex occurs to a greater extent with benzodiazepines as compared to zopiclone.
3. In the non-REM sleep phase, zopiclone does not modify the structure of unperturbed sleep but induces a highly significant reduction in increased values of Cyclic Alternating Pattern (CAP) rate in response to white noise. CAP is a physiological electroencephalographic component of non-REM sleep that reflects a condition of sustained arousal instability, and, subsequently, the subjective appreciation of sleep quality.

[Absorption]
Bioavailability: 80%

[Distribution]
Protein Binding: 45%

[Metabolism]
Metabolism Sites: Liver, extensive, major via decarboxylation

[Excretion]
Zopiclone and its metabolites are mainly excreted via the kidney pathway.

[Elimination Half Life]
3.5 to 6.5 hours

Hypersensitivity to zopiclone;
severe respiratory impairment (eg, significant sleep apnea syndrome);
myasthenia gravis;
severe hepatic insufficiency. [UTD]

Fetal risk has been demonstrated. [MDX]

Advise women to avoid breastfeeding during zopiclone therapy. [MDX]

(Frequency not defined)
[Cardiovascular] Palpitations
[Central nervous system] Aggressiveness behavior, anterograde amnesia (rare; dose-related; elderly are at particular risk), anxiety, ataxia, bitter taste, confusion, depression, dizziness, drowsiness, euphoria, hypotonia, impaired morning arousal, intoxicated feeling, memory impairment, nervousness, speech disturbance
[Dermatological] Diaphoresis
[Gastrointestinal] Anorexia, constipation, coated tongue, halitosis, increased appetite, sialorrhea, xerostomia
[Neuromuscular & skeletal] Tremor, weakness

[Insomnia] 7.5 mg PO, administered 30 to 60 minutes before bedtime. Higher doses (10 and 15 milligrams nightly) have not been more effective in most patients with insomnia, and may increase the incidence of adverse effects.
However, doses of 10 to 15 milligrams may be indicated in selected patients, such as psychiatric inpatients.
Zopiclone should only be used for severe insomnia and for durations not to exceed 28 days.

Nil.

Nil.

Severe hepatic insufficiency is contraindicated.

Nil.