Nasen – composition, action, indications, dosage. Nasen and driving

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Nasen is used primarily in neurology and psychiatry. It is available at a pharmacy only after prescription by a doctor. Its active substance is zolpidem, a short-acting hypnotic drug belonging to the imidazopyridine group. This substance shortens the time needed to fall asleep, affects the length of sleep and its quality, and reduces the number of awakenings. What is the composition and action of the drug Nasen? What are the indications and contraindications to its use and what side effects can it cause? How to take this preparation and with what drugs not to combine it?

Insomnia is a serious social problem and according to the World Health Organization it is one of the most frequently diagnosed ailments, right after pain. Sleep is extremely important for our mental and physical health. Problems with sleep, its length and quality can be effectively treated, inter alia, pharmacologically. For the short-term treatment of insomnia, the drug Nasen is used, among others.

Nasen – general characteristics of the drug

Nasen is a preparation characterized by a hypnotic effect. The international name of this drug is Zolpidemi tartras.

Nasen is used in the short-term treatment of insomnia, which disturbs the proper functioning or is very burdensome for the patient.

The active substance is zolpidem, a short-acting hypnotic from the imidazopyridine group. The active substance shortens the time needed to fall asleep and reduces the number of awakenings, improving and extending its quality.

Nasen is sold under a prescription issued by a doctor.

This preparation is in the form of 10 mg film-coated tablets and is sold in two pack sizes containing 20 pieces or 30 pieces.

Cena place in Nas it is not refundable and ranges from PLN 14 to PLN 19, depending on the packaging.

The drug should be stored in the original packaging, out of the sight and reach of children at a temperature of 15 ° C to 25 ° C. Before using Nasen, read the package leaflet or consult your doctor or pharmacist.

The distributor of Nasen in Poland is Polfarmex SA, a recognized producer of generic drugs. The company’s products are available on the markets of Central and Eastern Europe, the Baltic States and the Far East. The company specializes in the production of prescription generic drugs (Rx) in the field of pulmonology, cardiology, gastrology, neurology, dermatology and gynecology. They also offer a wide range of over-the-counter (OTC) drugs, dietary supplements and cosmetics.

Where do sleep problems come from and how to deal with them? Read: Problems with sleeping. How to deal with insomnia?

Nasen – composition and mechanism of action of the drug

The active substance of Nasen is zolpidem tartrate, which has a hypnotic and sedative effect. One tablet of the drug contains 10 mg of the active substance, the action of which is similar to that of a benzodiazepine.

The effect of Nasen is related to the fact that zolpidem binds to the benzodiazepine receptor, which is part of the GABA-A receptor complex. The active substance of the drug relatively selectively activates the type 1 benzodiazepine receptor. Activation of the receptor opens the chloride channel, which in turn leads to inhibition of the neuron’s excitability.

The drug Nasen, thanks to the active substance zolpidem, has a rapid hypnotic effect, making you fall asleep faster, extends the total duration of sleep, improves its quality and reduces the number and duration of night awakenings.

The auxiliary substances are: microcrystalline cellulose, lactose monohydrate, hypromellose, magnesium stearate and sodium carboxymethyl starch (type A). However, the drug coating contains substances such as: lactose monohydrate, hypromellose, macrogol (6000) and titanium dioxide (E 171).

After oral administration, Nasen is quickly absorbed from the gastrointestinal tract and its maximum concentration is obtained within 2 hours of taking the preparation. The effect of the drug is visible about 10-30 minutes after taking the drug and lasts up to 6 hours. The active substance is metabolized in the liver and excreted in the form of inactive metabolites, mainly via the urine and faeces.

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Nasen – indications for the use of the drug

Nasen can only be obtained with a prescription issued by a doctor, who recognizes the need for this medicine. This preparation is indicated in the short-term treatment of insomnia. Nasen is indicated for adults when insomnia becomes troublesome or makes it difficult or even impossible to function properly.

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Nasen – contraindications to the use of the drug

The drug Nasen, although there are indications for its use, may not always be used in every patient.

The main contraindication to the use of this drug is hypersensitivity, i.e. allergy to any component of the drug.

The contraindications to the use of Nasen also include certain diseases and circumstances that may require you to completely abandon this drug or change the dosage of the preparation.

The use of Nasen requires specific follow-up examinations and a thorough medical history. Before prescribing the drug, the doctor should determine causes of insomnia and strive to eliminate the factors that cause it. If the insomnia persists after 7-14 days of treatment, it may be a sign of a primary mental or physical disorder that requires further diagnosis.

Taking special precautions when using Nasen is recommended in people:

  1. with obstructive sleep apnea syndrome;
  2. with myasthenia gravis (excessive muscle fatigue after exercise);
  3. with severe liver failure;
  4. with severe respiratory failure.

Nasen should not be used in children and adolescents under 18 years of age.

People who are addicted to alcohol, stimulants or drugs should exercise particular caution when using Nasen. Patients in this group should be under close medical observation when using this preparation.

Nasen drug used for more than a few weeks may reduce its hypnotic effect and lead to the development of addiction. The physician should individually assess the patient’s risk of using the drug.

How Can You Deal With Insomnia? Check: Seven ways to fight insomnia

Nasen – dosage and method of using the drug

The drug Nasen, which is available on prescription, should be used according to the doctor’s instructions. Any doubts about the dosage and method of taking should be consulted with a doctor or pharmacist.

This medicine is intended for use by adults and should not be given to children and adolescents under 18 years of age.

The recommended dose of Nasen is 10 mg per 24 hours and in some cases, your doctor may prescribe a lower dose.

Elderly patients (over 65 years of age) and debilitated patients should start treatment with Nasen at a dose of 5 mg (half a tablet), not exceeding a dose of 10 mg (1 tablet) at bedtime. The possibility of increasing the dose is possible in people under 65 years of age if the patient is in good condition and the drug is well tolerated by the body.

People with hepatic insufficiency are recommended to take a dose of 5 mg (half a tablet) of Nasen just before going to bed.

This preparation should be taken in a single administration and immediately before bedtime. The duration of treatment is from a few days to 2 weeks. Like other hypnotics, the preparation must not be used for more than 4 weeks. Breaks between taking the drug and starting activities that require increased concentration should last at least 8 hours. The dose determined by the doctor should be adhered to, because exceeding it will not increase the effectiveness of the drug and may harm your health and life.

What might the effects of insomnia be? Read: What is the risk of insomnia? Serious health effects

Sleeping – overdosing or missing a dose

Nasen should be used as indicated and recommended by your doctor. In the event of an overdose, there may be varying degrees of disturbance of consciousness, leading to coma and excessive sleepiness.

A major risk may be an overdose of the drug with alcohol and other drugs that depress the central nervous system.

Any overdose of Nasen requires medical attention. If it is within an hour of taking the increased dose, it is recommended to induce vomiting or gastric lavage when the patient is unconscious. It is also recommended to administer activated charcoal.

In the event of an overdose, cardiovascular and respiratory function should be monitored, and treatment should be symptomatic and supportive. Your doctor may decide to give you flumazenil, but this may cause neurological symptoms such as seizures.

If a dose is missed, a double dose should not be taken to make up for the forgotten dose.

Your doctor should decide on the end of therapy with Nasen. Discontinuation of the drug should be gradual, as in patients using high doses of the drug, abrupt discontinuation of treatment may result in the occurrence of a withdrawal syndrome.

The characteristic symptoms that may occur after drug discontinuation are: headache, muscle pain, increased anxiety and tension, irritability, confusional state, insomnia, psychomotor agitation. In severe cases, the following may occur: derealization, depersonalization, hallucinations, numbness and tingling in the limbs, epileptic seizures, hypersensitivity to sounds, noise, light or touch.

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Side effects after using Nasen

Nasen, like all medicines, may cause side effects that do not have to occur in every person using this medicine. After authorization of the medicinal product, it is important to report any suspected adverse reactions so that the benefit / risk balance of the medicinal product can be monitored.

The general classification of the frequency of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare ( ≥100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

Side effects that may occur with the use of Nasen, especially the symptoms of the central nervous system and the digestive system, depend on the dose of the drug.

Among the side effects that have been reported so far after using Nasen are:

  1. nervous system disorders: dizziness, light-headedness, headache, drowsiness, anterograde amnesia (memory impairment), apathy (reduced sensitivity to emotional and physical stimuli), emotional lability (emotional lability), sleep disturbance, change in taste, ataxia (impaired coordination of movements), unsteady gait;
  2. mental disorders: night restlessness, nightmares;
  3. heart disorders: palpitations, occasionally cardiac arrhythmia (disturbance of the heart rhythm);
  4. blood and lymphatic system disorders: changes in the blood picture, e.g. leukopenia (decrease in the number of leukocytes in the blood), agranulocytosis (severe reduction or absence of neutrophils);
  5. endocrine disorders: menstrual disorder;
  6. reproductive system and breast disorders: decreased libido (decreased sex drive);
  7. musculoskeletal and connective tissue disorders: muscle spasms, arthritis;
  8. disorders of the respiratory system, thoracic and mediastinum: cough, asthma;
  9. metabolism and nutrition disorders: change in appetite, increased thirst, change in body weight;
  10. stomach and intestinal disorders: diarrhea, nausea, vomiting, flatulence;
  11. immune system disorders: hypersensitivity reactions such as rash, hives;
  12. eye disorders: blurred vision.

The side effects that may occur after taking Nasen will be less severe if it is taken just before going to bed.

After taking the tablet, the patient does not sleep for at least 7-8 hours, subsequent amnesia may occur.

Side effects affecting psychomotor performance usually appear in people who took more than the recommended dose, did not observe the required 8-hour interval between swallowing the tablet and performing activities requiring concentration, and consumed alcohol, drugs or other pharmacological agents that increase the concentration of zolpidem in the blood at the same time.

Although the drug Nasen may have side effects, it should be remembered that the expected benefits of using this medicine are usually greater than the harm resulting from the occurrence of side effects. If any of the above side effects or other effects not mentioned above occur, please inform your doctor or pharmacist immediately.

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Sleep, pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor before taking any medication to explain all the potential risks and benefits of any medication.

It is recommended that if a woman is pregnant, suspects she may be pregnant or is planning to have a baby, she should inform the prescribing physician of this fact.

The active substance of Nasen should not be used during pregnancy, especially in the first trimester. Also, the use of Nasen in the second and third trimesters of pregnancy and the perinatal period is not recommended, as it may cause respiratory failure, hypothermia or hypotension in the newborn.

In addition, long-term use of Nasen during pregnancy may result in the development of a drug withdrawal syndrome or physical dependence in the baby.

Studies have shown that zolpidem is excreted in small amounts into breast milk, therefore Nasen is not recommended for women who are breastfeeding. Taking Nasen is not recommended during pregnancy and lactation, so if you are pregnant or breastfeeding and think you may be pregnant or are planning to have a baby, you should stop using this preparation and consult your doctor, as it is recommended in these cases, change the treatment method as soon as possible.

How Can I Deal With Sleep Problems During Pregnancy? Check: Insomnia in pregnancy – how to deal with it?

Nasen and driving

Nasen may have an effect on the nervous system and mental state of the patient. This preparation may have a negative effect on the ability to drive and use machines. It is recommended not to drive or use machines for 7 to 8 hours after taking Nasen, as you may experience excessive sleepiness, among other things, which may cause you to “fall asleep at the wheel”.

This medicine may also cause amnesia, drowsiness, myorelation (muscle relaxation) and impaired coordination.

The next day after taking Nasen, it may happen that you feel sleepy, sleepy, feel dizzy, feel confused, have reduced reflexes, become less alert and may experience reduced vision (blurred or double vision).

Minimizing the risk of the above-mentioned events can be avoided by taking a break of at least 8 hours between taking Nasen and driving, operating machinery and working at heights. You should also avoid the consumption of alcohol and psychoactive substances while taking Nasen, as it may intensify the above-mentioned effects.

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Nasen – interactions with other drugs

The initiation of treatment with Nasen requires a detailed history of all recently taken medications, including over-the-counter medications.

The use of certain medications at the same time as taking Nasen can cause serious side effects. Before taking the drug, tell your doctor or pharmacist about all the drugs you are taking, or have recently taken, and about the drugs you plan to start taking.

The use of drugs that inhibit or enhance the activity of the cytochrome P450 system (e.g. erythromycin) may increase or decrease the effect of zolpidem, while rifampicin may reduce the effect of Nasen.

Some drugs used simultaneously with Nasen may increase sleepiness and cause psychomotor disorders the next day, including impaired driving ability. Among the drugs that interact with Nasen, the following are distinguished:

  1. drugs for the treatment of depression;
  2. drugs for the treatment of epilepsy;
  3. medicines to treat problems sleeping (sleeping pills);
  4. medicines used to treat certain mental health disorders (antipsychotics);
  5. medicines to treat moderate to severe pain (narcotic pain relievers);
  6. drugs used in anesthesia;
  7. medications to calm down or reduce anxiety;
  8. medicines to treat hay fever, rashes or other allergies which may make you feel sleepy (sedative antihistamines).

Particular caution should be exercised when taking zolpidem with antidepressants, including bupropion, desipramine, fluoxetine, sertraline and venlafaxine, as the so-called visual hallucinations.

It is also not recommended to use Nasen simultaneously with fluvoxamine or ciprofloxacin, as it may increase the blood levels of zolpidem.

The use of Nasen requires a careful interview regarding the use of other medicinal or herbal preparations, on the basis of which the doctor assesses the risk of including this preparation in the treatment process individually.

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