【藥品性質提示】 根據 2019 AGS Beers Criteria，本藥品為【潛在不適當用藥 (PIM)】，不建議用於老年人。

失眠 Short-term treatment of insomnia with difficulty of sleep onset in adults<20220412>
#仿單變更2021#仿單變更2022

Hypnotic agent
Zolpidem is a hypnotic agent with a chemical structure unrelated to benzodiazepines. In contrast to benzodiazepines, zolpidem in vitro binds the BZ1 receptor preferentially with a high affinity ratio of the alpha1/ alpha5 subunits.

Absorption
Biphasic absorption; rapid initial absorption (similar to immediate release product); then provides extended concentrations in the plasma beyond 3 hours postadministration
Distribution
Protein binding: ~93%
Metabolism
Hepatic methylation and hydroxylation via CYP3A4 (~60%), CYP2C9 (~22%), CYP1A2 , CYP2D6, and CYP2C19 to 3 inactive metabolites
Excretion
Urine(48% to 67%, primarily as metabolites); feces(29% to 42%, primarily as metabolites)
Pharmacodynamics
1. Onset of action: (Immediate release) 30 minutes
2. Duration: (Immediate release) 6 to 8 hours
3. Half-life elimination: ~2.5 hours; prolonged in elderly

1. Hypersensitivity to zolpidem or any component of the formulation
2. Patients who have experienced complex sleep behaviors after taking zolpidem <2021/8/18>

C
Severe neonatal respiratory depression and sedation have been reported when zolpidem was used at the end of pregnancy

Should consider the risk and benefits; Monitor the infant for excess sedation, hypotonia, and respiratory depression

Common:
lightheadedness, fatigue, headache, drowsiness, decreased memory, confusion, depression, nausea vomiting, falling, GI pain, dry mouth, complex sleep behaviors<20210818>, delirium <20220412>
Warnings:
Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following the use of zolpidem. Some of these events may result in serious injuries, including death. Discontinue immediately if a patient experiences a complex sleep behavior.<2021/8/18>

1. Initial 5 mg (females) or 5 to 10 mg (males) immediately before bedtime with ≥7 to 8 hours of planned sleep before waking
2. For patients taking higher doses of zolpidem (eg, 10 or 12.5 mg/day) for an extended period, slowly taper

Children and Adolescents ≤17 years:
1. Limited data available; Usual reported dose: 0.25 mg/kg at bedtime (maximum 10 mg/dose)
2. Has not been shown to be effective with ADHD-associated insomnia

No dosage adjustment necessary

1. Mild to moderate impairment: 5 mg immediately before bedtime
2. Severe impairment: Avoid use