February 28 2020

ZOLPIDEM
Indications and usage     

The active ingredient zolpidem is a hypnotic drug chemically unrelated to benzodiazepines, a large family of substances with sedative and hypnotic properties. The features of this drug include decreased sleep latency and increased sleep duration, preserving the depth. Unlike other drugs with hypnotic properties, the elimination speed is quite high.

Zolpidem is a substance indicated to induce sleep at short-term orally

Medizzine recommends that you consult your doctor if you are unsure why your doctor has prescribed zolpidem.

Other ingredients of available commercial presentations:

Tablets: Besides the active ingredient, commercial preparations may contain lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, methylcellulose, magnesium stearate, titanium dioxide (E171) and polyethylene glycol 400

Warning

The composition of the various presentations may vary from one country to another. We recommend you consult the information provided by your local supplier.

Aditional warning     

This medicine in tablets contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact with him before taking this medication.

Before taking the drug     

Do not use zolpidem

If you are allergic (hypersensitive) to the active substance zolpidem or any of the other ingredients of the medicinal product prescribed to you. If you think you may be allergic, ask your doctor.

Allergy symptoms may include:

- Asthma attacks with shortness of breath, audible wheezing or rapid breathing.
- More or less sudden swelling of face, lips, tongue or elsewhere in the body. It is especially critical if it affects the vocal cords.
- Hives, itching, rash
- Anaphylactic shock (loss of consciousness, paleness, sweating, etc.).

Stop taking zolpidem away if you have any rash or any other sign of allergy.

Before starting treatment make sure your doctor knows if you:

- Have a liver disorder
- Suffer muscle weakness
- Suffer from other sleep disorders
- Have allergies.

Take special care with zolpidem

If you have a liver disorder or suffer muscle weakness, your doctor will decide whether you should to take a lower dose of zolpidem or do not take it at all.

After taking zolpidem is recommended to sleep all the night or to have a rest period to avoid the possible occurrence of anterograde amnesia (the patient can not remember what happened while you were awake).

Risk of dependence:

The use of zolpidem may lead to physical and psychological dependence. This mainly occurs after taking the drug Continuously for a long time.

To minimize the risk of dependence should be observed these precautions :

- Take these medicines only when prescribed by your doctor (never by reasons as "has worked in other patients") and never should recommended to others.
- Not increase the doses prescribed by the doctor, neither prolong treatment longer than recommended.
- Consult your doctor regularly to decide whether to continue treatment.

By stopping the administration may appear restlessness, anxiety, insomnia, lack of concentration, headache, confusion, irritability, tension and hot flashes. Is not recommended, in general, discontinue abruptly the medication but gradually reduce the dose, according to the doctor's instructions.

In some cases, may occur a transient syndrome with similar symptoms that at first but in augmented manner. These symptoms may be accompanied by other reactions including mood changes, anxiety, sleep disturbances and restlessness. It is important to know that can occur this rebound phenomenon to minimize anxiety that may cause the appearance of these effects after cessation of treatment.

Treatment should be discontinued at the possible occurrence of reactions as restlessness, worsening of insomnia, irritability, aggression, delusions, rages, nightmares, hallucinations, abnormal behavior or other behavioral disorders, sleepwalking and other behaviors such as driving, eating etc. without remembering these facts because the patient is not fully awake.

Pathological situations

Impaired liver function

If you have liver disease, let your doctor know if prescribes zolpidem. Patients with hepatic impairment eliminate this drug more slowly than healthy people, so it is necessary to reduce the initial dose of the drug.

Impaired lung function

If you have sleep apnea or chronic bronchial pulmonary disease or, should make it known to your physician when prescribed zolpidem. The sleep-inducing drugs and sedatives ones may depress respiratory function and should be taken some precautions.

Depression

If you suffer from depression or are being treated for this disease, tell to your doctor if he prescribe zolpidem.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal products or drugs obtained without a prescription. It is important, especially if you are taking:

When taking zolpidem with other medicines that act on the brain, the combination may make you more drowsy than it should.

- Drugs used to treat mental illness (antidepressants, antipsychotics)
- Drugs for treating anxiety (anxiolytics, sedatives)
- Drugs used to relieve severe pain (analgesics, anesthetics)
- Drugs used to treat convulsions/seizures (AEDs)
- Antihistamines
- Ketoconazole, which may increase the sedative effect.

Due to the risk of additive effects of substances which can depress the nervous system, it is necessary to warn your doctor about medications you are taking before beginning treatment with zolpidem.

Other times, the effect is neutralization of sleep-inducing action of zolpidem, as with rifampicin.

Use with food and beverages

During treatment with zolpidem, avoid alcoholic beverages. The effect of alcohol may enhance the sedation, and this may affect the ability to drive or operate machinery. If you need further information on this point see your doctor.

Special physiological situations

Pregnancy

Not recommended for use during pregnancy. There are no studies evaluating the effects of zolpidem on the children of mothers who took the drug during pregnancy. However, as with other similar drugs, there is some risk that the baby may have withdrawal symptoms at birth. Some newborns have a significant laxity related to the taking of zolpidem by their mothers.

The active ingredient zolpidem belongs to the category B of the classification of the FDA.

Nursing mothers:

Part of zolpidem ingested by the mother passes into the milk, although its effect on the baby is unknown. Use in mothers who breastfeed their children is not recommended.

Children:

There are not established efficacy and safety of zolpidem in patients under 18 years.

Elderly:

In elderly is desirable to reduce the standard dose of 10 mg. to half a tablet(5 mg). This advice is based on increasing the concentration of drug in the elderly and in an extension of the time it takes to eliminate from the body with respect to the young population.

There is an increased risk of impaired intellectual capacity and the ability to movements in elderly people receiving zolpidem. This is an additional reason to reduce by half the initial dosage and to closely monitor the situation of the elderly patient.

Driving and using machines

Zolpidem may impair the ability to drive or operate machinery due to the possible decrease in alertness, especially if you have drunk alcohol, or if sleep duration was not enough (7-8 hours), so you should not drive or operate machines during treatment.

Consult your doctor or pharmacist before taking any medicine.

How to use zolpidem     

Follow exactly instructions of use of zolpidem provided by your doctor. Consult your doctor or pharmacist when in doubt. Follow the instructions of the physician in preference to those given in this website, that may be different. Ask your doctor to explain any aspect that you do not understand, contained in the instruction leaflet that comes with the medicine.

The usual dose is 10 mg immediately before bedtime. Swallow it without chewing, with water or another nonalcoholic beverage.

The drug exerts its action quickly, so you should use it just before going to sleep.

The elderly and debilitated persons may be particularly sensitive to the effects of zolpidem, so you should start treatment with half the recommended dose.

Taken with or immediately after a meal slows moderately onset of effect of the drug, but also prolongs the effect in the same proportion.

If you take the medicine for a long period of time, you will notice some loss of effects, a phenomenon known in medicine as tolerance. If you need to take the medication for a period of more than seven or eight days, you should consult your doctor about the possibility of having an underlying disease that is causing the insomnia.

Generally, zolpidem causes no effect in next morning after taking the drug it or effects have low intensity.

Most of the side effects of zolpidem are in direct proportion to the dose administered. Therefore, must be used the minimum effective dose.

Normally it will not take more than 20 minutes to fall asleep after taking zolpidem, and is convenient to ensure that you can sleep without being woken for at least 7-8 hours. Otherwise, although this happens rarely, you may not remember what happened while you were awake.

In most cases, is needed only a short-term treatment with zolpidem 10 mg (generally should not exceed two weeks).

To avoid withdrawal symptoms, patients should not abruptly stop taking zolpidem, especially if they have been taking the drug for a long time.

If you think that the effect of the medicine is too strong or too weak, consult your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

While you take zolpidem     

If you become pregnant, contact your doctor immediately.

If a doctor prescribes another medicine , tell you are taking zolpidem.

Check with your doctor regularly developments of disorder that motivates the use of zolpidem. Maybe there is some reason that prevented you properly receive the indicated doses and induce your doctor to erroneous conclusions about treatment.

Do not restart treatment with zolpidem at your own risk without first talking to your doctor, nor encourage its use by another person, even if have the same symptoms you have. Nor is it advisable to interrupt or reduce the dose without considering the opinion of your doctor.

If you feel unwell during treatment with zolpidem, immediately consult your doctor.

If you use more medicine than you should

If you have taken more medicine than you should, immediately consult your doctor or pharmacist or go to the nearest hospital, carrying the container with the rest of medication not consumed, even if you feel well.

In mild cases, symptoms include drowsiness, mental confusion and lethargy. In more severe cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, impaired consciousness and even get to coma or a more severe symptomatology including fatal outcome.

If you forget to take zolpidem

Do not take a double dose to compensate forgotten individual doses.

Consequences of abrupt discontinuation of treatment

Abrupt discontinuation of treatment may lead to withdrawal effects, manifested by headache or muscle, anxiety, tension, restlessness, confusion and irritability.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Side Effects of zolpidem     

Like all medicines, zolpidem can cause side effects, although not everybody gets them.

The frequency of side effects is classified into:

Very common: affect 1 out of 1-10 patients
Common: affect 1 out of 10-100 patients
Uncommon: affect 1 out of 100-1.000 patients
Rare: affect 1 out of 1.000-10.000 patients
Very Rare: affect less than 1 in 10,000 patients
Incidence not known: Can not be established the true incidence from the available data

Have been shown the relationship between dose and adverse effects. These effects should be reduced if zolpidem is administered immediately before bedtime or after lying.

These effects are more common in elderly patients and includen:

Nervous system disorders

Common side effects:

Drowsiness, headache, dizziness, worsening of insomnia, anterograde amnesia (can not remember what happened while he was awake after taking the medicine). The amnesia may be associated with inappropriate behavior.

Side effects of incidence not known:

Decreased alertness.

Psychiatric disorders

Common side effects:

Hallucinations, agitation, nightmares.

Uncommon side effects:

Confusion, irritability.

Side effects of incidence not known:

Restlessness, aggressiveness, delusions, rages, psychosis, abnormal behavior, sleepwalking, change in sexual desire.

General disorders

Common side effects:

Fatigue.

Side effects of incidence not known:

Gait disturbance, tolerance to the drug, falls (especially in the elderly and when not have been appropiately followed the doctor's recommendations.

Eye disorders

Uncommon side effects:

Double vision.

Gastrointestinal disorders

Common side effects:

Diarrhea, nausea, vomiting, abdominal pain.

Musculoskeletal and connective tissue disorders

Side effects of incidence not known:

Muscular weakness.

Disorders of the skin and subcutaneous tissue

Side effects of incidence not known:

Itching, rashes, angioedema, urticaria, excessive sweating.

Hepatobiliary disorders

Side effects of incidence not known:

Increased hepatic enzymess.

Depression

Rhe zolpidem use may unmask a depression disorder. Since insomnia can be a symptom of depression, if insomnia persists, consult your doctor to evaluate your situation

If you notice any side effects not listed in this website or in the leaflet accompanying the container, ask your doctor or pharmacist.

If any of the side effects gets serious, tell your doctor or pharmacist.

Date page update: October 26, 2010.