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Zopiclone 7.5mg

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$15.00
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Product Description

Short term treatment of insomnia, including difficulties in falling asleep, nocturnal awakening and early awakening, transient, situational or chronic insomnia, and insomnia secondary to psychiatric disturbances, in situations where the insomnia is debilitating or is causing severe distress for the patient.Long term continuous use is not recommended. A course of treatment should employ the lowest effective dose.

Posology and method of administration

The duration of treatment should be limited to 4 weeks, including any tapering off.

Adults: The recommended dose is one 7.5mg tablet shortly before retiring.

Elderly: A lower dose of 3.75mg should be employed to start treatment in the elderly. Depending upon effectiveness and acceptability, the dosage subsequently may be increased if clinically necessary to 7.5mg/day.

Patients with hepatic insufficiency: As elimination of zopiclone may be reduced in patients with hepatic dysfunction a lower dose of 3.75mg nightly is recommended. The standard dose of 7.5mg may be used with caution in some cases, depending upon effectiveness and acceptability.

Patients with renal insufficiency: Accumulation of zopiclone or its metabolites has not been seen during treatment of insomnia in patients with renal insufficiency. However it is recommended that patients with impaired renal function should start treatment with 3.75mg.

Zopiclone is not recommended for use in children.

Contraindications

Zopiclone is contraindicated in patients with myasthenia gravis, respiratory failure, severe sleep apnoea syndrome, severe hepatic insufficiency and those people with a hypersensitivity to zopiclone or any other ingredient in the product. As with all hypnotics, zopiclone should not be used in children.

Special warnings and precautions for use

Use in hepatic insufficiency: A reduced dosage is recommended, see Posology.

Use in renal insufficiency: A reduced dosage is recommended, see Posology.

Risk of dependence: Clinical experience to date with zopiclone suggests that the risk of dependence is minimal when the duration of treatment is limited to not more than 4 weeks.

Use of benzodiazepines and benzodiazepine-like agents (even at therapeutic doses) may lead to the development of physical and psychological dependence on these products. The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of alcohol and/or drug abuse, or those who have marked personality disorders. The decision to use a hypnotic in such patients should be taken only with this clearly in mind. If physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures. Rare cases of abuse have been reported.

Withdrawal: The termination of treatment with zopiclone is unlikely to be associated with withdrawal effects when duration of treatment is limited to 4 weeks. Patients may benefit from tapering of the dose before discontinuation.

Depression: As with other hypnotics, zopiclone does not constitute a treatment for depression. Any underlying cause of the insomnia should also be addressed before symptomatic treatment.

Tolerance: Some loss of efficacy to the hypnotic effect of benzodiazepines and benzodiazepine-like agents may develop after repeated use for a few weeks. However, with zopiclone, there is an absence of any marked tolerance during treatment periods of up to 4 weeks.

Rebound insomnia: This is a transient syndrome where the symptoms which led to treatment with a benzodiazepine or benzodiazepine-like agent recur in an enhanced form on discontinuation of therapy. It may be accompanied by other reactions including mood changes, anxiety and restlessness. Since the risk of withdrawal/rebound phenomena may be increased after prolonged treatment, or abrupt discontinuation of therapy, decreasing the dosage in a stepwise fashion may be helpful.

A course of treatment should employ the lowest effective dose for the minimum length of time necessary for effective treatment. See posology for guidance on possible treatment regimen. A course of treatment should not continue for longer than 4 weeks including any tapering off.

Amnesia: Amnesia is rare, but anterograde amnesia may occur, especially when sleep is interrupted or when retiring to bed is delayed after taking the tablet. Therefore, patients should ensure that they take the tablet when certain of retiring for the night and they are able to have a full night's sleep.

Effects on ability to drive and use machines

lthough residual effects are rare and generally of minor significance, patients should be advised not to drive or operate machinery the day after treatment until it is established that their performance is unimpaired.

Concomitant use with alcohol is not recommended. In particular this could affect the patients ability to drive or use machines the next day.

Undesirable effects


A mild bitter or metallic after-taste is the most frequently reported adverse effect. Less commonly, mild gastrointestinal disturbances, including nausea and vomiting, dizziness, headache, drowsiness and dry mouth have occurred.

Psychological and behavioral disturbances, such as irritability, aggressiveness, confusion, depressed mood, anterograde amnesia, hallucinations and nightmares have been reported. Rarely these reactions may be severe and may be more likely to occur in the elderly.

Rarely allergic and allied manifestations such as urticaria or rashes have been observed, and more rarely, light headedness and incoordination.

Withdrawal and rebound insomnia have occasionally been observed on discontinuation of treatment, mainly in association with prolonged treatment.

 

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