Zopisign (Zopiclone) 10 mg – US Domestic

What is Zopisign (Zopiclone)?

Zopisign belongs to the group of central nervous system (CNS) depressants (medicines that make you sleepy and less alert). Zopiclone treats insomnia (trouble falling asleep), and reduces daytime anxiety. Zopisign helps you fall asleep faster and sleep through the night with fewer interruptions in deep sleep, helping people with sleeping problems. In general, when sleep medicines are used every night for a long time, they may lose their effectiveness.

Zopiclone is available only with your doctor’s prescription.

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Zopisign indications

In the treatment of transient, situational, and chronic insomnia.

In the case of situational transient insomnia, such as in shift workers, short-term treatment (3-7 days) with Zopiclone at the recommended dosage will be sufficient to re-establish normal sleep.

In insomnia secondary to psychiatric disorders, including difficulty falling asleep, nocturnal awakenings, and early awakening.

Insomnia caused by more persisting life stress or psychological distress can demand longer treatment with Zopisign than for situational-transient insomnia. However, patients need to be periodically assessed for their insomnia, and treatment should not be prolonged if not necessary.

Uses of Zopiclone in details

Zopiclone is used to treat insomnia (inability to sleep) in adults, including difficulty falling asleep, waking in the night or too early in the morning, severe sleep problems due to mood or mental health problems.

Zopiclone description

Novo-Zopiclone is a novel hypnotic agent used in the treatment of insomnia. Its mechanism of action is based on modulating benzodiazepine receptors. In addition to Zopisign’s benzodiazepine pharmacological properties, it also has some barbiturate-like properties.

Zopisign dosage

The dose of Zopiclone: an average therapeutic dose of Zopisign Synthon Pharmaceuticals is 7.5 mg orally at night; in cases of severe insomnia, the dose can be increased up to 15 mg. In elderly patients, as well as abnormal liver function is used 3.75 mg.

Zopisign interactions

Zopisign also interacts with trimipramine and caffeine. Alcohol has an additive effect when combined with Zopiclone, enhancing the adverse effects, including the overdose potential of Zopisign significantly. A study assessing the impact of Zopisign on driving skills the next day found that the impairments on driving skills are double that of a social dose of alcohol. Zaleplon had no detrimental effects on driving skills the next day. Carbamazepine also has additive effects when combined with Zopisign, with both drugs enhancing each other’s side effects.

Erythromycin appears to increase the absorption rate of Zopisign and prolong the elimination half-life of Zopisign, leading to increased plasma levels and more pronounced effects. Itraconazole has a similar effect on Zopisign pharmacokinetics as erythromycin. The elderly may be particularly sensitive to the erythromycin and itraconazole drug interaction with Zopisign.

Temporary dosage reduction during combined therapy may be required, especially in the elderly. Rifampicin causes a very notable reduction in the half-life of Zopisign and peak plasma levels, which results in a large reduction in the hypnotic effect of Zopisign. Phenytoin and carbamazepine may also provoke similar interactions. Ketoconazole and sulfaphenazole interfere with the metabolism of Zopisign. Nefazodone impairs the metabolism of Zopisign, leading to increased Zopisign levels and marked next-day sedation. Contact your doctor or pharmacist to get more information

Zopiclone side effects

The side effect most commonly seen in clinical trials is taste alteration or dysgeusia (bitter, metallic taste, usually fleeting in most users but can persist until the drug’s half-life has expired). Palpitations may occur in the daytime following withdrawal from the drug after prolonged use (especially when taken for more than two weeks).

Zopisign induces amnesia type memory impairments similar to triazolam and Rohypnol. Impairment of driving skills with a resultant increased risk of road traffic accidents is probably the most important side effect. This side effect is not unique to Zopisign but also occurs with other hypnotic drugs.

More common reactions

Gastrointestinal: taste disturbances including bitter metallic taste, dry mouth. Nervous system: disruption of REM sleep, double vision, drowsiness, memory impairments, visuospatial impairments, dizziness, headaches, and fatigue. Unexpected mood changes have been noted, which, if experienced, should lead to the drug being withdrawn from the patient.

Less common reactions

Gastrointestinal: heartburn, constipation, diarrhea, nausea, coated tongue, bad breath, anorexia or increased appetite, vomiting, epigastric pains, dyspepsia, dehydration, parageusia.

Cardiovascular: palpitations in elderly patients.

Skin: urticaria, tingling in the arms and legs.

Miscellaneous: blurred vision, frequent micturition, mild to moderate increases in serum transaminases and/or alkaline phosphatase, and interstitial nephritis have been reported very rarely.

Reproductive: impotence, delayed ejaculation, anorgasmia in both women and men.

Nervous system: agitation, anxiety, loss of memory including retrograde and anterograde amnesia, confusion, dizziness, weakness, somnolence, asthenia, moderate to severe euphoria and/or dysphoria, feeling of drunkenness, depression, sleepwalking, coordination abnormality, hypotonia, speech disorder, hallucinations of various strengths, usually auditory and visual, behavioral disorders, aggression, tremor, rebound insomnia, nightmares, hypomania. Delirium can also occur but is a side effect mainly seen in the elderly.

Zopiclone contraindications

Zopisign causes impaired driving skills, which are similar to benzodiazepines. Long term users of hypnotic drugs for sleep disorders only develop partial tolerance to adverse effects on driving. Even after 1-year of use, users of hypnotic drugs still show an increased motor vehicle accident rate.

Patients who drive motor vehicles should not take Zopiclone unless they stop driving due to a significantly increased risk of road traffic accidents in Zopisign users. Zopisign induces impairment of psychomotor function. Driving or operating machinery should be avoided after taking Zopiclone as effects can carry over to the next day, including impaired hand-eye coordination.

Patients with a history of substance abuse should not be prescribed Zopisign, as it has a very high potential for problematic drug misuse. Zopiclone is known to, in some cases, induce a state of amnesia, which is largely related (and not too dissimilar to ’sleep-walking’).

This can extend to sleep-eating, sleep-talking (quite naturally), to dangerously ’sleep-driving.’ It is, therefore usually not used as an anti-anxiety drug (such as Benzodiazepines), as the patient may be liable to make inferior judgment decisions (as they are essentially mentally ’asleep’) and attempt dangerous activities. – With absolutely no recollection at all of the events.