Hypnor is prescription medication, available in Egypt, other north africa and middle east countries. Hypnor produced by AMOUN PHARMACEUTICAL .
Name of the medicinal product
Hypnor 5 mg tablets.
Qualitative and quantitative composition
Active ingredients: zopiclone 7.5 mg.
Pharmaceutical form
Film coated tablet.
هيبنور أقراص HYPNOR
Therapeutic indications
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
Adults: The recommended dose is 7.5 mg zopiclone by the oral route shortly before retiring.
Elderly: A lower dose of 3.75 mg zopiclone should be employed to start treatment in the elderly. Depending on effectiveness and acceptability, the dosage subsequently may be increased if clinically necessary.
Children and young adults less than 18 years: the safe and effective dose has not yet been established.
Patients with hepatic insufficiency: As elimination of zopiclone may be reduced in patients with hepatic dysfunction, a lower dose of 3.75 mg zopiclone nightly is recommended. The standard dose of 7.5 mg may be used with caution in some cases, depending on effectiveness and acceptability.
Patients with renal insufficiency: Accumulation of zopiclone or its metabolites has not seen during treatment of insomnia in patients with renal insufficiency However, it is recommended that patients with impaired renal function should start treatment with 3.75 mg .
Treatment duration:Treatment with zopiclone should be as short as possible. Generally the duration of treatment varies from a few days to two woks with a maximum, including the tapering off, of four weeks.
In certain cases an extension beyond the maximum treatment period may be necessary, if so it should take place after re-evaluation of the patient’s status.
Route of administration: Each film-coated tablet should be swallowed whole without sucking, chewing or breaking.
Contraindications
Zopiclone 7.5 mg tablets 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 to any of the excipients.
- As with all hypnotic, zopiclone 7.5 mg tablets, should not be used in children.
- patients with a personal or family history of sleepwalking.
Special warnings and precautions for use
Use in hepatic insufficiency: A reduced dosage is recommended.
Use in renal insufficiency: A reduced dosage is recommended.
Risk of dependence: Clinical experience to date with Zopiclone 7.5 mg tablets 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 upon these products. The risk of dependence increases with dose and duration of treatment. It is also greater in patients with a history of alcohol 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 in mind. If physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of:
- Headache.
- neck pain.
- Muscle pain.
- Extreme anxiety.
- Tension.
- Restlessness.
- Confusion.
- Irritability.
In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness or tingling of the extremities, hypersensitivity to light, noise and physical contact or epileptic seizures. Rare cases of abuse have been reported.
withdrawal: The termination of treatment with Hypnor 7.5 mg tablets 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, Hypnor 7.5 mg tablets, does not constitute a treatment for depression. Any underlying cause of the insomnia should be also addressed ,before symptomatic treatment to avoid under treating potentially serious effects of depression. Prescribers are reminded to exclude depression as the underlying source of insomnia.
Tolerance: Some loss of efficacy to the hypnotic effect of benzodiazepines and benzodiaz -like agents may develop after repeated use for a few weeks. However, Zopiclone there is an absence of any marked tolerance during treatment periods of up to 4 weeks.
For more about Hypnor warnings and precautions for use, see Hypnor Patient Information Leaflet- Click here.
Pregnancy and lactation
Evidence of use of zopiclone during pregnancy in humans is limited although there have been no adverse findings in animals. Use in pregnancy is therefore not recommended. if the product is prescribed to a woman of child bearing potential, she should be advised to contact her physician about stopping the product it she intends to become pregnant, or suspects that she is pregnant.
Moreover, if zopiclone is used during the last three months of pregnancy or during labour, due to the pharmacological action d the product , effects on the neonate, such as hypothermia. hypnotic and respiratory depression can be expected.
Infants born to mothers who took benzodiazepines or benzodiazepine- like agents chronically during the latter stages of pregnancy may have developed physical dependence and may be at risk of developing withdrawal symptoms in the postnatal period.
Lactation: Zopiclone is excreted in breast milk,and use in nursing mothers must be avoided.
Effects on ability to drive and use machines
Although 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. The risk is increased by concomitant intake of alcohol
Undesirable effects
Nervous system disorders: Less commonly, dizziness, headache and drowsiness have occurred. More rarely, light-headedness and incoordination have been observed.
Psychological and behavioural disturbances, such as irritability, aggressiveness, confusion, depressed mood, anterograde amnesia, sleepwalking, hallucinations and nightmares have been reported rarely.
Withdrawal symptoms: vary and may include rebound Insomnia, anxiety, trend sweating agitation, confusion, headache, palpitations, tachycardia delirium, nightmares, hallucinations, panic attacks, muscle aches/cramps and irritability In very rare cases seizures may occur
Gastrointestinal disorders: less commonly, mild gastrointestinal disturbances, inducing nausea and vomiting have occurred.
Hepatic disorders: Mild to moderate increases in serum transaminases and/or alkaline phosphatase have been reported very rarely.
Immune System Disorders: Angiooedema and/or anaphylactic reactions have been reported very rarely.
Skin and subcutaneous tissue disorders: Rarely, allergic and allied manifestations such as urticaria or rashes have been observed.
General disorders and administration site conditions: A mild bitter or metallic after-taste is the most frequently reported adverse effect. Less commonly, dry mouth has occurred.
Dependence: Use (even at therapeutic doses) may lead to the development of physical dependence.Discontinuation of the therapy may result in withdrawal or rebound phenomena. Psychological dependence may occur.
Hypnor Patient Information Leaflet
