Zosleep® (zolpidem) tablets

Zosleep® (zolpidem) tablets

Packaging

30 pieces

Type of drug

Oral

Dosage

5mg, 10mg

Insomnia or sleep deprivation is a common problem that usually occurs intermittently and temporarily. Sleeping pills such as zolpidem are recommended in the final stages and if the problem does not resolve, and these drugs are also usually prescribed for a short time to regulate sleep. Zolpidem belongs to a…

Zosleep® Zolpidem
5 and 10 mg coated tablets

This medicine has been prescribed to treat your current condition, so do not use it in similar cases or recommend it to others.
General instructions:
Inform your doctor if you are allergic to zolpidem, foods, dyes, or other medicines.
Take the medicine in the amount and for the duration recommended by your doctor. Taking more than this will increase the risk of unwanted side effects.
If you are being treated regularly with this medicine and you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular medication schedule. Do not double the dose.
Tell your doctor if you are taking this medicine with other medicines such as antihistamines, cold relievers, sleeping pills, tranquilizers, painkillers and narcotics, barbiturates, antiepileptics, muscle relaxants or anesthetics such as some anesthetics used in dentistry, central nervous system depressants or tricyclic antidepressants amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, nortriptyline, protriptyline and trimipramine. The central nervous system depressant effects of zolpidem may be increased by taking any of these medicines at the same time and may cause unwanted effects.
While taking this medicine, a person should have a full night’s sleep (7-8 hours) to avoid memory problems.
Medical problems such as excessive alcohol consumption, drug dependence or misuse or a history of them, emphysema, asthma, bronchitis or other chronic lung diseases, depression, sleep apnea, kidney or liver disease may affect the effects of zolpidem. Tell your doctor if you have any of these.
Zolpidem can be taken on an empty or full stomach. It works faster if taken on an empty stomach.
Take zolpidem only before going to bed and when you are ready to sleep. This medication works very quickly.
You may have trouble falling asleep for several nights after you stop taking this medication, which will then go away.
Use in pregnancy and lactation:
Pregnancy: Use during pregnancy has not been studied in humans, but an animal study has shown that taking this drug during pregnancy slows down the growth of the fetus. If you are pregnant or planning to become pregnant, inform your doctor.
Breastfeeding: Although zolpidem is secreted in breast milk, there have been no reports of adverse effects on the nursing infant. In any case, inform your doctor if you are breastfeeding.
Precautions:
This drug may cause drowsiness, dizziness, and decreased alertness, so avoid doing things that require full alertness, such as driving or operating heavy machinery.
If your work schedule does not allow you to get a full night’s sleep (7-8 hours), avoid taking this drug because there is not enough time for the effects of the drug to wear off before this time has passed and you may feel sleepy or have memory problems.
Avoid taking this tablet with alcohol or drugs that affect the central nervous system.
This drug has only been studied in adults and there is no specific information about the use of this drug in children.
Do not take the drug for more than the amount and duration prescribed by your doctor.
If you plan to use this drug for more than 7 days, be sure to consult your doctor.
Side effects:
Any drug may cause unwanted side effects along with the desired therapeutic effect. Although not all of these side effects will occur in every person, see your doctor if you experience any of the following side effects:
Uncommon side effects: restlessness, unsteadiness, tremors, confusion (more common in older people), and depression
Rare side effects: dizziness, confusion, weakness, falls (more common in older people), palpitations, itchy skin, hallucinogenic effects (seeing, hearing, or touching things that are not there), facial swelling, trouble sleeping, unusual excitement, nervousness, irritability, snoring, or trouble breathing.
The following side effects may also occur that do not require medical attention. These may go away on their own as you continue taking the medication
But if they persist or become bothersome, you should see your doctor:
Abdominal or stomach pain, daytime sleepiness, double vision or other vision problems, dry mouth, feeling sick or generally unwell, headache, memory problems, nausea, nightmares, or unusual dreams. After stopping the use of the drug, the body may need a period of time to adapt to the new conditions. The length of this period depends on the amount of the drug taken and the length of time it has been used. During this period, inform your doctor if you experience any of the following side effects:

Feeling of discomfort or contraction in the stomach or abdominal area, agitation and distress, nervousness or feeling of pain, seizures, hot flashes, confusion, muscle cramps, nausea, sweating, tremors, uncontrollable crying, unusual fatigue or weakness, vomiting, worsening of mental and emotional problems.
Overdose symptoms:
Breathing problems, unconsciousness, severe drowsiness, severe nausea and vomiting, staggering when walking. In case of overdose, the patient should be taken to the hospital immediately.
Dosage and method of administration:
The amounts mentioned below are the average amount of consumption and the exact amount will be determined by the doctor:
For the treatment of insomnia or sleep disorders:
Adults: 10 mg before bedtime. In elderly people, 5 mg should be taken before bedtime.
Children and people under 18 years of age: The amount and duration of use should be determined by the doctor.
Storage conditions:
Keep out of the reach of children.
Store in the original box away from light and moisture until use.
Avoid storing and using expired medication.
Dosage Forms and Packaging:
Each Zoslip 5 mg film-coated tablet contains 5 mg of zolpidem tartrate, packaged in boxes of 30, along with a leaflet.
Each Zoslip 10 mg film-coated tablet contains 10 mg of zolpidem tartrate, packaged in boxes of 30, along with a leaflet.

Insomnia or sleep deprivation is a common problem that usually occurs intermittently and temporarily. Sleeping pills such as zolpidem are recommended in the last stages and if the problem does not resolve, and these drugs are also usually prescribed for a short time to regulate sleep. Zolpidem belongs to a class of drugs called Z-drugs. This drug facilitates falling asleep by accelerating the induction of sleep messages to the brain.

Zolpidem is similar in function to benzodiazepines and affects GABA receptors. These receptors are widely distributed in the brain. Binding to the GABA receptor site increases the neurotransmission effects of this chemical mediator. This binding causes the opening of chloride channels on the receptor and increases the polarization of the neuron.
Benzodiazepines appear to potentiate the inhibitory effect of GABA, thereby reducing neuronal excitability in many brain regions.

Zolpidem is rapidly absorbed from the gastrointestinal tract after oral administration, reaching peak plasma levels within 3 hours. It undergoes first-pass metabolism in the liver, and its absolute bioavailability is approximately 70%. Its elimination half-life is approximately 2.5 hours, and it is approximately 92% protein-bound. It is primarily metabolized by the cytochrome P450 isoenzyme CYP3A4. Inactive metabolites of the drug are excreted in the urine and feces. The drug is excreted in breast milk.

General Interaction Profile:
– CYP1A2 Substrate
– CYP3A4 Substrate
– Exacerbation of CNS Depressant Effects

Class X Interactions (Avoid):
Azelastine (nasal), Bromperidol, Orphenadrine, Oxomemazine, Paraldehyde, Rifampin, Sodium Oxybate, Tea Tree, Thalidomide

Reduction in Drug Effects by Zolpidem:
No significant interactions noted.

Reduced effects of zolpidem by drugs:
Carbamazepine, moderate and strong CYP3A4 inducers, dabrafenib, deferasirox, enzalutamide, erdafitinib, ivocidinib, mitotane, rifampin, sarilumab, siltuximab, catechins, tocilizumab

Increased effects of zolpidem by drugs:
Azelastine (nasal), blonanserin, buprenorphine, carbamazepine, flunitrazepam, methotripsy, metyrosine, orphenadrine, oxycodone, paraldehyde, piribedyl, pramipexole, ropinirole, rotigotine, sodium oxybate, suvorexant, thalidomide

Increased effects of zolpidem by drugs:
Alizapride, brimonidine (topical), bromopride, bromperidol, cannabidiol, marijuana (control), chlormethiazole, Chlorpheniramine carbamate, ciprofloxacin (systemic), CNS depressants, strong CYP3A4 inhibitors, dimetinden (topical), dronabinol, droperidol, fluvoxamine, itraconazole, kava, ketoconazole (systemic), lamborxant, lisuride, lofexidine, magnesium sulfate, melatonin, methotrimeprazine, metoclopramide, minocycline (systemic), nabilone, oxomemazine, prampanel, ritonavir, rufinamide, tetrahydrocannabinol, tetrahydrocannabinol and cannabidiol

Food interactions:
Maximum plasma concentration and bioavailability are reduced when the drug is taken with food; time to peak plasma concentration is increased; half-life is unchanged.
Recommendation: Do not take the drug with food or immediately after food.

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