Uses: Sleep Aid
Chemical Name: Zolpidem Tartrate
Quantity: 30 Tabs
Ivedal (zolpidem tartrate) sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
The clinical trials performed with Zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
Short term treatment of insomnia in adults.
Benzodiazepines or benzodiazepine-like agents are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.
The short-term treatment of insomnia in adults in situations where the insomnia is debilitating or is causing severe distress for the patient.
Ivedal (zolpidem tartrate extended-release tablets) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).
The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration.
Ivedal (zolpidem tartrate) Oral Spray is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies. The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
Dosage In Adults
Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness. The total dose of Ivedal should not exceed 10 mg once daily immediately before bedtime.
The recommended initial doses for women and men are different because zolpidem clearance is lower in women.
Special Populations
Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of Ivedal in both of these patient populations is 5 mg once daily immediately before bedtime.
Use With CNS Depressants
Dosage adjustment may be necessary when Ivedal is combined with other CNS-depressant drugs because of the potentially additive effects.
Administration
The effect of Ivedal may be slowed by ingestion with or immediately after a meal.
Ivedal sublingual tablet should be placed under the tongue, where it will disintegrate. The tablet should not be swallowed and the tablet should not be taken with water.
For oral administration.
Treatment should be as short as possible. Generally the duration of treatment varies from a few days to two weeks with a maximum, including the tapering off process, of four weeks. The tapering off process should be tailored to the individual.
As with all hypnotics, long-term use is not recommended and a course of treatment should not exceed four weeks. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient's status.
The product acts rapidly and therefore should be taken with fluid just before going to bed, or in bed.
Adults
The treatment should be taken in a single intake and not be re-administered during the same night.
The recommended daily dose for adults is 10 mg to be taken immediately at bedtime. The lowest effective daily dose of Ivedal should be used and must not exceed 10 mg.
Elderly (over 65 years) or debilitated patients
Elderly or debilitated patients may be especially sensitive to the effects of Ivedal therefore a 5 mg dose is recommended. These recommended doses should not be exceeded.
Hepatic impairment
Patients with hepatic insufficiency do not clear the drug as rapidly as normal individuals; therefore dosage should begin at 5 mg in these patients with particular caution being exercised in elderly patients. In adults (under 65 years) dosage may be increased to 10 mg only where the clinical response is inadequate and the drug is well tolerated.
The total dose of Ivedal should not exceed 10mg in any patients.
Paediatric population
Safety and effectiveness of Ivedal in paediatric patients under the age of 18 years have not been established.
Posology
The treatment should be taken in a single intake and not be re-administered during the same night.
The recommended daily dose for adults is 10 mg to be taken immediately at bedtime. The lowest effective daily dose of zolpidem should be used and must not exceed 10 mg.
As with all hypnotics, long-term use is not recommended and a course of treatment should not exceed four weeks. The duration of treatment should usually vary from a few days to two weeks with a maximum of four weeks including tapering off where clinically appropriate. In certain cases extension beyond the maximal treatment period may be necessary; if so, this should not take place without re-evaluation of the patient's status.
Special populations
Paediatric population
Zolpidem is not recommended for use in children and adolescents below 18 years of age, due to a lack of data to support use in this age group.
Elderly
Elderly or debilitated patients may be especially sensitive to the effects of zolpidem therefore a 5 mg dose is recommended. These recommended doses should not be exceeded.
Hepatic impairment
As clearance and metabolism of zolpidem is reduced in hepatic impairment, dosage should begin at 5 mg in these patients with particular caution being exercised in elderly patients. In adults (under 65 years) dosage may be increased to 10 mg only where the clinical response is inadequate and the drug is well tolerated.
Zolpidem must not be used in patients with severe hepatic impairment as it may contribute to encephalopathy.
