Zopim Special Precautions

Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.
Complex sleep-related behaviors, which may include sleep driving, making phone calls, preparing and eating food (while asleep).
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.
Specific patient groups: Depression: As with other sedative/hypnotic drugs, zolpidem tartrate should be administered with caution in patients exhibiting symptoms of depression. Suicidal tendencies may be present therefore, the least amount of drug that is feasible should be supplied to these patients because of the possibility of intentional overdosage by the patient.
Use in patients with a history of drug or alcohol abuse: 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.
General information: 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 as follows.
Tolerance: Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines and benzodiazepine-like agents may develop after repeated use for a few weeks.
Dependence: Use of benzodiazepines or benzodiazepine-like agents may lead to the development of physical and psychological dependence. The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of psychiatric disorders and/or alcohol or drug abuse.
These patients should be under careful surveillance when receiving hypnotics.
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: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise, and physical contact, hallucinations, or epileptic seizures.
Rebound insomnia: 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 be 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.
Amnesia: Benzodiazepines or benzodiazepine-like agents 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 7-8 hours.
Psychiatric and "paradoxical" reactions: Reactions like restlessness, aggravated insomnia, agitation, irritability, aggressiveness, delusion, rage, nightmares, hallucinations, psychoses, inappropriate 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.
Effect on Ability to Drive and Use Machines: Zolpidem has major influence on the ability to drive and use machines.
Vehicle drivers and machine operators should be warned that, as with other hypnotics, there may be a possible risk of drowsiness, prolonged reaction time, dizziness, sleepiness, blurred/double vision and reduced alertness, and impaired driving the morning after therapy. In order to minimize 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 behaviors 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 behaviors. Patients should be warned not to use alcohol or other psychoactive substances when taking zolpidem.
Use in Children: Safety and effectiveness in children below the age of 18 have not been established.
Use in the Elderly: See dose recommendations.