Most commonly observed adverse events in controlled trials: If you have myasthenia gravis, you may already have lower oxygen levels. If you stop taking zolpidem Keep taking zolpidem until your doctor tells you to stop. You should also tell your doctor if you drink alcohol. Zolpidem may also cause other side effects. Zolpidem Tartrate 5mg
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|Zolpidem tartrate typical dosage of citalopram||The mean half-life in cirrhotic patients of tratrate. Zolpidem 10mg Tablets are oblong, white to off-white, film-coated tablets, with a score line and Tartrate on one side. Other zolpidem and zolpidem Please tablet your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. RARE Observed in a small fraction of population. Do not pass it on to others.|
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Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches or muscle pain, extreme anxiety and tension, restlessness, confusion and irritability. In severe cases the following symptoms may occur: A transient syndrome whereby the symptoms that led to treatment with a benzodiazepine or benzodiazepine-like agent recur in an enhanced form, may occur on withdrawal of hypnotic treatment. It may be accompanied by other reactions including mood changes, anxiety and restlessness.
It is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms should they occur when the medicinal product is discontinued. Since the risk of withdrawal phenomena or rebound has been shown to be greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually where clinically appropriate. There are indications that, in the case of benzodiazepines and benzodiazepine-like agents with a short duration of action, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high.
Benzodiazepines or benzodiazepine-like agents such as zolpidem may induce anterograde amnesia. The condition occurs most often several hours after ingesting the product and therefore to reduce the risk patients should ensure that they will be able to have an uninterrupted sleep of 8 hours see section 4. Other psychiatric and paradoxical reactions like restlessness, exacerbated insomnia, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, psychosis, abnormal behaviour and other adverse behavioural effects are known to occur when using benzodiazepines or benzodiazepine-like agents.
Should this occur, use of the product should be discontinued. These reactions are more likely to occur in the elderly. The use of alcohol and other CNS-depressants with zolpidem appears to increase the risk of such behaviour, as does the use of zolpidem at doses exceeding the maximum recommended dose. Discontinuation of zolpidem should be strongly considered for patients who report such behaviour for example, sleep driving , due to the risk to the patient and others.
Due to its pharmacological properties, zolpidem can cause drowsiness and a decreased level of consciousness, which may lead to falls and consequently to severe injuries. The sedative effect may be enhanced when the product is used in combination with alcohol. This affects the ability to drive or use machines. Therefore, concomitant use of zolpidem with these drugs may increase drowsiness and next-day psychomotor impairment, including impaired driving ability see section 4.
Also, isolated cases of visual hallucinations were reported in patients taking zolpidem with antidepressants including bupropion, desipramine, fluoxetine, sertraline and venlafaxine. Co-administration of fluvoxamine may increase blood levels of zolpidem, concurrent use is not recommended. In the case of narcotic analgesics enhancement of euphoria may also occur leading to an increase in psychological dependence.
The concomitant use of sedative medicines such as benzodiazepines or related drugs such as zolpidem with opioids increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dosage and duration of concomitant use should be limited see section 4. Co-administration of ciprofloxacin may increase blood levels of zolpidem, concurrent use is not recommended. Compounds which inhibit certain hepatic enzymes particularly cytochrome P may enhance the activity of benzodiazepines and benzodiazepine-like agents.
The pharmacodynamic effect of zolpidem is decreased when it is administered with a CYP3A4 inducer such as rifampicin and St. John's Wort has been shown to have a pharmacokinetic interaction with zolpidem. Mean C max and AUC were decreased John's Wort compared to zolpidem administered alone. John's Wort may decrease blood levels of zolpidem, concurrent use is not recommended. However when zolpidem was administered with itraconazole a CYP3A4 inhibitor its pharmacokinetics and pharmacodynamics were not significantly modified.
The clinical relevance of these results is unknown. Co-administration of zolpidem with ketoconazole mg twice daily , a potent CYP3A4 inhibitor, prolonged zolpidem elimination half-life, increased total AUC, and decreased apparent oral clearance when compared to zolpidem plus placebo. The total AUC for zolpidem, when co-administered with ketoconazole, increased by a factor of 1. A routine dosage adjustment of zolpidem is not considered necessary, but patients, should be advised that use of zolpidem with ketoconazole may enhance the sedative effects.
Since CYP3A4 plays an important role in zolpidem metabolism, possible interactions with drugs that are substrates or inducers of CYP3A4 should be considered. When zolpidem was administered with ranitidine no significant pharmacokinetic interactions were observed. For zolpidem tartrate, no or very limited amount of data on pregnant patients are available.
Although animal studies have shown no teratogenic or embryotoxic effects, safety in pregnancy has not been established. As with all drugs zolpidem should be avoided in pregnancy particularly during the first trimester. If the product is prescribed to a woman of childbearing potential, she should be warned to contact her physician about stopping the product if she intends to become or suspects that she is pregnant. If, for compelling medical reasons, zolpidem is administered during the late phase of pregnancy, or during labour, effects on the neonate, such as hypothermia, hypotonia and moderate respiratory depression, can be expected due to the pharmacological action of the product.
Cases of severe neonatal respiratory depression have been reported when zolpidem tartrate was used with other CNS depressants at the end of pregnancy. 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 some risk of developing withdrawal symptoms in the postnatal period.
Small quantities of zolpidem appear in breast milk. The use of zolpidem in nursing mothers is therefore not recommended. In order to minimise this risk a resting period of at least 8 hours is recommended between taking zolpidem and driving, using machinery and working at heights. Driving ability impairment and behaviours such as 'sleep-driving' have occurred with zolpidem alone at therapeutic doses.
Furthermore, co-administration of zolpidem with alcohol and other CNS depressants increases the risk of such behaviours see sections 4. Patients should be warned not to use alcohol or other psychoactive substances when taking zolpidem. There is evidence of a dose-relationship for adverse effects associated with zolpidem use, particularly for certain CNS and gastrointestinal events.
As recommended in section 4. They occur most frequently in elderly patients. Liver enzymes elevated, hepatocellular, cholestatic or mixed liver injury see sections 4. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: In cases of overdose, involving zolpidem alone or with other CNS-depressant agents including alcohol , impairment of consciousness ranging from somnolence to coma, and more severe symptomatology, including fatal outcomes have been reported.
General symptomatic and supportive measures should be used. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. Sedating drugs should be withheld even if excitation occurs. Use of flumazenil may be considered where serious symptoms are observed. Flumazenil is reported to have an elimination half-life of about 40 — 80 minutes. Patients should be kept under close observation because of this short duration of action; further doses of flumazenil may be necessary.
However, flumazenil administration may contribute to the appearance of neurological symptoms convulsions. Zolpidem is not dialyzable. The value of dialysis in the treatment of an overdose has not been determined. Dialysis in patients with renal failure receiving therapeutic doses of zolpidem has demonstrated no reduction in levels of zolpidem. In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.
Zolpidem is an imidazopyridine which selectively binds the omega-1 receptor subtype also known as the benzodiazepine-1 subtype which is the alpha unit of the GABA-A receptor complex. Whereas benzodiazepines non-selectively bind all three omega receptor subtypes, zolpidem preferentially binds the omega-1 subtype. The modulation of the chloride anion channel via this receptor leads to the specific sedative effects demonstrated by zolpidem.
These effects are reversed by the benzodiazepine antagonist flumazenil. The randomized trials only showed convincing evidence of efficacy of 10 mg zolpidem. In a randomized double-blind trial in non-elderly healthy volunteers with transient insomnia, zolpidem 10 mg decreased the mean time to fall asleep by 10 minutes compared to placebo, while for 5 mg zolpidem this was 3 minutes.
In a randomized double-blind trial in non-elderly patients with chronic insomnia, zolpidem 10 mg decreased the mean time to fall asleep by 30 minutes compared to placebo, while for 5 mg zolpidem this was 15 minutes. The selective binding of zolpidem to omega-1 receptors may explain the virtual absence at hypnotic doses of myorelaxant and anti-convulsant effects in animals which are normally exhibited by benzodiazepines which are not selective for omega-1 sites.
The preservation of deep sleep stages 3 and 4 - slow-wave sleep may be explained by the selective omega-1 binding by zolpidem. All identified effects of zolpidem are reversed by the benzodiazepine antagonist flumazenil. Safety and efficacy of zolpidem have hot been established in children aged less than 18 years. A randomized placebo-controlled study in children aged 6 — 17 years with insomnia associated with Attention Deficit Hyperactivity Disorder ADHD failed to demonstrate efficacy of zolpidem 0.
Psychiatric and nervous system disorders comprised the most frequent treatment emergent adverse events observed with zolpidem versus placebo and included dizziness Zolpidem has both a rapid absorption and onset of hypnotic action. Peak plasma concentration is reached at between 0. The elimination half-life is short, with a mean of 2. Protein binding amounts to Repeated administration has been shown not to modify protein binding indicating a lack of competition between zolpidem and its metabolites for binding sites.
The distribution volume in adults is 0. You should check all the possible interactions with your doctor before starting any medicine. Interaction with Alcohol moderate Description - Concomitant use of sedative and hypnotics with alcohol will increase the central nervous system and respiratory system depression. Instructions - Consumption of alcohol with this medicine is not recommended as it increases the risk of side effects like dizziness, difficulty in concentration.
Interaction with Medicine Opoids severe Antihypertensives moderate. Disease interactions Depression severe Zolpidem Tartrate 5 MG Tablet should be used with caution in the patients with the history of depression or a family history of depression. The prescription size should be limited. Any symptoms of mood changes should be reported to the doctor immediately.
Food interactions Information not available. Lab interactions Information not available. This is not an exhaustive list of possible drug interactions. Do not take in larger amounts than advised. Consult the doctor if you experience any undesirable effects. Do not stop taking the medicine without consulting your doctor as it may cause withdrawal symptoms.
Warnings for special population Pregnancy - This medicine is not recommended for pregnant women unless necessary. Breast-feeding - This medicine is known to excreted in breast milk. General warnings Withdrawal symptoms - Zolpidem Tartrate 5 MG Tablet should not be stopped immediately without informing the doctor due to the risk of withdrawal symptoms like convulsions, behavioral disorder, tremor, and anxiety. Gradual dose reduction should be made based on the outcomes in the patient.
Impaired liver function - Zolpidem Tartrate 5 MG Tablet should be used with caution in the patients with mild to moderate liver injury. Lowest possible doses should be initiated and increase the dose based on the patient's response. This medicine is not recommended in patients with severe liver impairment.
Suicidal thoughts - Use of benzodiazepines in depression conditions may increase the risk of suicide. Therefore this medicine should be used with caution and prescription size should be limited in patients with depression or suicidal tendencies. Dependency - Zolpidem Tartrate 5 MG Tablet have the tendency to cause dependency and abuse particularly after prolonged use or excessive dosages. Individuals with a history of alcohol or substance abuse should be treated carefully when they are on Zolpidem Tartrate 5 MG Tablet.
The withdrawal of this medicine should be tapered off gradually. To be taken on an empty stomach To be taken as instructed by doctor May cause sleepiness How it works It works by decreasing the excitability of brain cells and induces sleep. MedlinePlus Drug Information [Internet]. Chat with a doctor Get reply within 5 mins. Did you find this helpful? Your feedback will help us improve the product. Yes Thanks for your response. What can we improve? Thanks for your response.