Indications
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.
Therapeutic Class
Pharmacology
Dosage
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. The recommended dose of Zolpidem in these patients is 5 mg once daily immediately before bedtime
Patients with mild to moderate hepatic impairment do not clear the drug as rapidly as normal subjects. The recommended dose of Zolpidem in these patients is 5 mg once daily immediately before bedtime. Avoid Zolpidem use in patients with severe hepatic impairment as it may contribute to encephalopathy
Use With CNS Depressants: Dosage adjustment may be necessary when Zolpidem is combined with other CNS depressant drugs because of the potentially additive effects
Administration
Interaction
Imipramine, Chlorpromazine: Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance
Haloperidol: A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. The lack of a drug interaction following single-dose administration does not predict the absence of an effect following chronic administration
Alcohol: An additive adverse effect on psychomotor performance between alcohol and oral zolpidem was demonstrated
Sertraline: Concomitant administration of zolpidem and sertraline increases exposure to zolpidem
Fluoxetine: After multiple doses of zolpidem tartrate and fluoxetine an increase in the zolpidem half-life (17%) was observed. There was no evidence of an additive effect in psychomotor performance
Contraindications
Side Effects
Pregnancy & Lactation
Precautions & Warnings
Use in Special Populations
Overdose Effects
Management: Treatment is largely symptomatic and supportive. IV fluids should be administered as needed. Activated charcoal may be given if presented w/in 1 hr of ingestion of >1 mg/kg zolpidem in adults or childn. Gastric lavage may be considered if presented w/in 1 hr of ingestion of >100 mg zolpidem and monitor for at least 12 hr. Flumazenil may be used if there is severe CNS depression, but generally not needed. Haemodialysis is unlikely to be useful.
Reviews
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