She reportedly woke up vomiting from noxious combinations of food, developed an ulcer, and gained an unhealthy amount of weight very quickly. Concomitant use of zolpidem with these drugs may increase drowsiness and psychomotor impairment, including impaired driving ability. You should not use this medication if you are allergic to zolpidem. Ask your doctor how to avoid withdrawal symptoms when you stop using this medicine. Paediatric populations Safety and efficacy of zolpidem have hot been established in children aged less than 18 years. The elimination half-life is short, with a mean of 2. Excessive sedation Confusion and disorientation Lack of motor coordination Slow response times Delayed reflex reactions.
Zolpidem must not be used in patients with severe hepatic impairment as it may contribute to encephalopathy see section 4. Zolpidem tartrate is contraindicated in patients with a hypersensitivity to zolpidem tartrate or any of the excipients listed in section 6. In the absence of data, zolpidem should not be prescribed for children or patients with psychotic illness. The cause of insomnia should be identified wherever possible and the underlying factors treated before a hypnotic is prescribed.
The failure of insomnia to remit after a 7 — 14 day course of treatment may indicate the presence of a primary psychiatric or physical disorder, and the patient should be carefully re-evaluated at regular intervals. The risk of next-day psychomotor impairment, including impaired driving ability, is increased if:. Zolpidem should be taken in a single intake immediately at bedtime and not be re-administered during the same night. As hypnotics have the capacity to depress respiratory drive, precautions should be observed if zolpidem is prescribed to patients with compromised respiratory function.
Concomitant use of zolpidem and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as zolpidem with opioids should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe zolpidem concomitantly with opioids, the lowest effective dose should be used, and the duration of treatment should be as short as possible see also general dose recommendation in section 4.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their environment to be aware of these symptoms see section 4. Extreme caution should be exercised when prescribing for patients with a history of drug or alcohol abuse.
These patients should be under careful surveillance when receiving zolpidem tartrate or any other hypnotic, since they are at risk of habituation and psychological dependence. Suicidal tendencies may be present therefore the least amount of zolpidem that is feasible should be supplied to these patients to avoid the possibility of intentional overdose by the patient. Pre-existing depression may be unmasked during use of zolpidem. Since insomnia may be a symptom of depression, the patient should be re-evaluated if insomnia persists.
General information relating to effects seen following administration of benzodiazepines and other hypnotic agents which should be taken into account by the prescribing physician are described below. Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines and benzodiazepine-like agents like zolpidem may develop after repeated use for a few weeks. Use of benzodiazepines or benzodiazepine-like agents like zolpidem may lead to the development of physical and psychological dependence.
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. If you have taken zolpidem in the past, your doctor may direct you to take a lower dose of this medicine than you did before. Do not share this medication with another person , even if they have the same symptoms you have.
The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children. Misuse of this medication can result in dangerous side effects. Zolpidem may impair your thinking or reactions. You may still feel sleepy the morning after taking zolpidem, especially if you take the extended-release tablet, or if you are a woman. Wait at least 4 hours or until you are fully awake before you do anything that requires you to be awake and alert.
Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking zolpidem and talk with your doctor about another treatment for your sleep disorder. You should not use this medication if you are allergic to zolpidem. Zolpidem tablets may contain lactose.
Use caution if you are sensitive to lactose. Zolpidem may be habit forming and should be used only by the person it was prescribed for. Never share zolpidem with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. FDA pregnancy category C. It is not known whether zolpidem will harm an unborn baby.
Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Zolpidem can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby. It is dangerous to try and purchase zolpidem on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy.
Samples of zolpidem purchased on the Internet have been found to contain haloperidol Haldol , a potent antipsychotic drug with dangerous side effects. For more information, contact the U. Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. Zolpidem comes with patient instructions for safe and effective use.
Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. Never take Ambien , Edluar , or Zolpimist if you do not have a full 7 to 8 hours to sleep before being active again. Do not take Intermezzo for middle-of-the-night insomnia unless you have 4 hours of sleep time left before being active. Zolpidem is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row.
Do not take zolpidem for longer than 4 or 5 weeks without your doctor's advice. Do not stop using zolpidem suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medicine. Insomnia symptoms may also return after you stop taking zolpidem. These symptoms may seem to be even worse than before you started taking the medication. Call your doctor if you still have worsened insomnia after the first few nights without taking zolpidem.
Do not swallow the Edluar or Intermezzo tablet whole. Place the tablet under your tongue and allow it to dissolve in your mouth without water. Spray Zolpimist directly into your mouth over your tongue.