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What is Zolpidem and when is it used?

Zolpidem is a sleeping pill indicated for the short-term treatment of various forms of severe insomnia, in particular in case of difficult drowsiness, sleep interruption, as well as in premature awakening in patients over 18 years of age.

Although Zolpidem belongs to another class of chemicals, its mode of action is similar to that of another group of substances, the benzodiazepines.

It can only be taken on prescription.

What must also be taken into account during treatment?

Zolpidem should only be used in case of pronounced sleep disturbances and for a short time, generally for 7 - 10 days. Treatment should not exceed 4 weeks. Should the doctor exceptionally foresee a treatment of a longer duration, he will discuss with you the possibility of continuing the therapy; such an extension will subsequently require regular monitoring.

It is also useful to respect some rules on sleep hygiene, such as:

• limit the time you stay in bed; 8 hours is enough,
• avoid sleeping during the day,
• going to bed and getting up at regular times,
• do not use stimulating drinks: tea, coffee,
• moderate alcohol consumption.

When can Zolpidem not be taken / used?

Zolpidem should not be used as a long-term treatment. Treatment should be as short as possible, as the risk of addiction increases with its duration.

Zolpidem must not be used in the following cases:

sleep apnea syndrome (disturbed breathing balance with sleep interruptions at night), severe respiratory failure, excessive tendency to muscle fatigue (myasthenia gravis), severe liver failure (severe liver disorders), allergy to one of the components, Lactose intolerance.

Do not use Zolpidem if you have already had episodes of sleepwalking or other unusual behaviors, such as realizing that you have been doing activities even though you are not fully awake (such as driving, eating, calling or having sex ...) after taking Zolpidem.

When is caution required in the administration / use of Zolpidem?

Although it has no chemical relationship with benzodiazepines, Zolpidem has certain points in common with these substances in the mode of action, so it is worth remembering the following:

Taking Zolpidem can - as with all sleeping pills - lead to addiction. The risk of addiction is greater in case of prolonged use of Zolpidem and in people who have already suffered from psychiatric disorders, alcoholism or drug addiction , and causes, in case of abrupt discontinuation of the drug, withdrawal symptoms: agitation, anxiety , insomnia, impaired concentration, headache and sweating. These symptoms generally disappear after 2 - 3 weeks.

In order to minimize the risk of drug addiction, we invite you to follow the following recommendations:

• take Zolpidem only under a prescription (never on the advice of third parties!) and never pass it on to others,
• under no circumstances increase the dose prescribed by your doctor. Tell your doctor if you wish to stop taking the medicine,
• prolonged use (generally more than 4 weeks) can only take place under close medical supervision.

For older people , treatment should be done under close medical supervision.

In certain particular diseases (respiratory, hepatic, renal insufficiency), it may be necessary to adjust the dosage. The effect of this drug or its side effects may be more pronounced in these patients.

Children and adolescents : Do not use under 18 years as experience in this age group is limited.

Vehicle drivers and machine operators will need to pay close attention to the potential risk of sleepiness. A full night of sleep (7-8 hours) is recommended to reduce this risk.

If abnormal effects occur during the course of therapy, the attending physician must be notified immediately.

It is not recommended to take Zolpidem with alcohol, as the latter can enhance its effect.

In both depressed and non-depressed individuals, taking Zolpidem may increase the risk of suicide.

Other sedatives, such as antidepressants, sedatives, other sleeping pills, medications used to treat epilepsy or pain relievers such as opiates, can significantly enhance the effect of Zolpidem. If you suffer from depression or other behavioral disorders, you can only take Zolpidem with the explicit agreement of your doctor.

It is not recommended to take Zolpidem in conjunction with hypericum, as the latter could reduce the effect of the drug.

Cases have been reported of people who, after taking Zolpidem or a similar medicine, act during sleep (sleepwalking) and are not fully awake and do not remember it. Behaviors observed included sleepwalking while driving, while preparing meals, eating, telephoning or having sex, and isolated cases of self-harming behavior. These behaviors may be associated with the risk of injury to the patient and others, which can even lead to death. These behaviors can occur regardless of the intake of alcohol or other medications that affect the central nervous system in association with Zolpidem. If such behavior occurs, stop treatment immediately and inform your doctor or pharmacist.

Taking Zolpidem can cause drowsiness and decreased level of consciousness, which can lead to falls and serious injuries.

Zolpidem can reduce the ability to react, the ability to drive a vehicle and the ability to use tools or machines. It can also cause drowsiness or blurred vision. Drinking alcohol can aggravate unwanted effects.

Concomitant use of Zolpidem and opioids can cause sedation and respiratory failure, which can lead to coma or death. It is important to identify any signs or symptoms of respiratory failure and sedation and notify your doctor immediately.

Tell your doctor or pharmacist if

• suffer from other diseases,
• suffer from allergies or
• suffer from long QT syndrome,
• have already suffered from a mental disorder, abused or was addicted to alcohol or drugs,
• have already had episodes of sleepwalking or other unusual behaviors such as realizing that you have been doing activities while not fully awake (such as driving, eating, calling or having sex ...) after taking Zolpidem,
• takes or applies other medicines externally (even if purchased on his own initiative!)

Pregnancy: if you are pregnant or wish to become pregnant, you should contact your doctor and stop taking Zolpidem.

Breastfeeding: if breastfeeding, Zolpidem should not be taken, as a small amount of zolpidem passes into breast milk.

Follow your doctor's prescription. The dosage is usually 1 tablet of 10 mg to be taken in the evening, immediately before bedtime or when already in bed. Never exceed 1 tablet per night.

As a general rule, always take the smallest effective dose and this for the shortest period possible. Zolpidem should not be used for prolonged periods as the risk of habituation increases with the duration of treatment. If you are over 65, your doctor will generally prescribe a half tablet to start with. It is advisable not to exceed the dosage of 1 tablet of 10 mg. This tablet should be taken immediately before bedtime.

Do not change the prescribed dosage on your own. If you think that the effect of the medicine is too weak or too strong, talk to your doctor or pharmacist.

What side effects can Zolpidem have?

Side effects depend on the dose taken and on your individual sensitivity, especially if you are in old age.

These effects appear more often in the hour following the intake if you do not lie down and fall asleep immediately (see "How to use Zolpidem?"). They may also appear the next day upon awakening.

Hallucinations. agitation, nightmares, depression, daytime sleepiness, fatigue, headache, dizziness, insomnia aggravation, memory disturbance, diarrhea, nausea, vomiting, abdominal pain, back pain, upper and lower respiratory tract infections, memory disturbances . These complaints are more frequent when awake and still under the influence of the drug. It may happen that later it is not possible to remember what happened in this period of time.

Confusion, irritability, nervousness, aggression, sleepwalking, euphoric state, tingling, tremors, disturbance in attention, speech disturbances, altered appetite, joint and muscle pain, cramps, neck pain, blurred vision, double vision, rash skin, muscle weakness.

Change in sexual desire, decreased alertness, gait disturbance, liver function disturbances, jaundice, liver injury or inflammation, hives, falls (especially in elderly people or in patients who have not respected the recommended dosage).

Delirium, addiction, vision disturbances, respiratory depression.

State of anger, inappropriate behavior. Episodes of sleepwalking or other unusual behaviors such as realizing that you are engaged in activities while not fully awake (such as driving, eating, calling or having sex…) which can lead to serious, sometimes fatal injuries.

If you notice any side effects, please contact your doctor, pharmacist, especially if they are side effects not described in this package leaflet.

The medicinal product should not be used beyond the date indicated with "EXP" on the container.

The medicine should be stored at room temperature (15-25 ° C) out of the reach of children.

Your doctor or pharmacist, who have detailed professional information, can give you further information.

1 tablet contains 10 mg of zolpidem tartrate