Zolpidem Tartrate

What it is and how it works

Mechanism of Action Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of insomnia through binding to the benzodiazepine site of α1 subunit containing GABA A receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation.

Indications

Zolpidem tartrate extended-release tablets are indicated for the short-term 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 . Zolpidem tartrate extended-release tablet, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

Dosage and administration (summary)

Use the lowest dose effective for the patient and must not exceed a total of 12.5 mg daily Treatment should be as short as possible Recommended initial dose is a single dose of 6.25 mg for women, and a single dose of 6.25 or 12.5 mg for men, immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 6.25 mg for men and women Lower doses of CNS depressants may be necessary when taken concomitantly with zolpidem tartrate extended-release tablets Tablets to be swallowed whole, not to be crushed, divided or chewed The effect of zolpidem tartrate extended-release…

Contraindications

• Patients who have experienced complex sleep behaviors after taking zolpidem tartrate extended-release tablets • Known hypersensitivity to zolpidem Zolpidem tartrate extended-release tablets are contraindicated in patients who have experienced complex sleep behaviors after taking zolpidem tartrate extended-release tablets . with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema .

Warnings and precautions

CNS-Depressant Effects: Impaired alertness and motor coordination, including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Caution patients against driving and other activities requiring complete mental alertness the morning after use. Instruct patients on correct use. Need to Evaluate for Comorbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days of use. Severe Anaphylactic/Anaphylactoid Reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur.

Pregnancy

Pregnancy Risk Summary Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation . Published data on the use of zolpidem during pregnancy have not reported a clear association with zolpidem and major birth defects .

Storage and supply

Zolpidem tartrate extended-release tablets USP, 6.25 mg are composed of two layers* and are pink colored, round, biconvex, film-coated tablets debossed with "E61" on one side and "LU" on the other side and supplied as: NDC: 71335-2764-1: 100 Tablets in a BOTTLE *Layers are covered by the coating and are indistinguishable. Store at 25°C (77°F).

Source: Zolpidem Tartrate (Zolpidem Tartrate) — US FDA prescribing information, 2025-08-08, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.