|Warnings:Zolpidem should be used with caution in patients with sleep apnoea syndrome, and myasthenia gravis. Respiratory Insufficiency:As hypnotics have the capacity to depress respiratory drive precautions should be observed if zolpidem is prescribed to patients with compromised respiratory function.Hepatic Insufficiency:See dose recommendations.Precautions: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.|
4.4.1 Specific patient groupsElderly: See dose recommendations. Due to the myorelaxant effect, there is a risk of falls and consequent injury, particularly for elderly patients when they get up at night.
Psychotic illness: Hypnotics such as zolpidem are not recommended for the primary treatment of psychotic illness.
Paediatric Patients:Safety and effectiveness of zolpidem have not been established in patients below the age of 18 years. In an 8-week study in paediatric patients (aged 6-17 years) with insomnia associated with attention-deficit/hyperactivity disorder (ADHD), psychiatric and nervous system disorders comprised the most frequent treatment emergent adverse events observed with zolpidem versus placebo and included dizziness (23.5% vs 1.5%), headache (12.5% vs 9.2%), and hallucinations (7.4% vs. 0%). (See section 4.2 Posology and method of Administration).
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.
Next-day psychomotor impairmentThe risk of next-day psychomotor impairment, including impaired driving ability, is increased if:
• zolpidem is taken within less than 8 hours before performing activities that require mental alertness (see section 4.7);
• a dose higher than the recommended dose is taken;
• zolpidem is co-administered with other CNS depressants or with other drugs that increase the blood levels of zolpidem, or with alcohol or illicit drugs (see section 4.5).
Zolpidem should be taken in a single intake immediately at bedtime and not be re-administered during the same night.
Amnesia:Sedative/hypnotic agents such as zolpidem may induce anterograde amnesia. The condition occurs most often several hours after ingesting the product. In order to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 8 hours (see section 4.8).
Depression: Although no clinically significant pharmacokinetic and pharmacodynamic interactions with SSRIs have been demonstrated (see section 4.5 Interactions with other medicinal products and other forms of interactions), 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 zolpidem that is feasible should be supplied to these patients to avoid the possibility of intentional overdosage 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.
4.4.2 General informationGeneral information relating to effects seen following administration of hypnotic agents which should be taken into account by the prescribing physician are described below.
Tolerance:Some loss of efficacy to the hypnotic effects of sedative/hypnotic agents like zolpidem may develop after repeated use for a few weeks.
Dependence:Use of sedative/hypnotic agents like zolpidem 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 sedative/hypnotic agents 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. 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.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.In the case of sedative/hypnotic agents with a short duration of action, withdrawal phenomena can become manifest within the dosage interval.
Severe InjuriesDue to its pharmacological properties, zolpidem can cause drowsiness and a decreased level of consciousness, which may lead to falls and consequently to severe injuries, see also section 4.8
Other Psychiatric and "paradoxical" reactions:Other Psychiatric and paradoxical reactions like restlessness, insomnia exacerbated, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, abnormal behaviour and other adverse behavioural effects are known to occur when using sedative/hypnotic agents like zolpidem. Should this occur, use of the product should be discontinued. These reactions are more likely to occur in the elderly.Somambulism and associated behaviours:Sleep walking and other associated behaviours such as sleep driving, preparing and eating food, making phone calls or having sex, with amnesia for the event, have been reported in patients who had taken zolpidem and were not fully awake. The use of alcohol and other CNS-depressants with zolpidem appears to increase the risk of such behaviours, 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 behaviours (for example, sleep driving), due to the risk to the patient and others (See section 4.5 Interactions with other medicinal products and other forms of interaction and section 4.8 Undesirable effects).
Intolerance:Patients with rare hereditary problems of galactose intolerance, the lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.