Zolpidem Tartrate

• Approved Use: Short-term treatment of insomnia, specifically for problems with sleep onset. Extended-release forms also treat sleep maintenance.
• Off‑Label/Clinically Accepted:
• Occasional treatment of middle-of-the-night awakenings when ≥4 hours remain before morning.
• Insomnia associated with psychiatric or medical conditions when non-pharmacologic treatment has been inadequate.

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Immediate-Release (Tablets, Spray, Sublingual)

• Women: Start at 5 mg once nightly, immediately before bed.
• May increase to 10 mg if needed and well-tolerated.
• Men: 5 mg–10 mg once nightly before bedtime.
• Administration: Must allow 7–8 hours for sleep before awakening. Do not repeat dose in the same night.

Extended-Release (CR Tablets)

• Women and Men: Typically 6.25 mg before bed; may increase to 12.5 mg if required.
• Same sleep duration requirements and no re-dosing.

Sublingual “Intermezzo”

• Women: 1.75 mg; Men: 3.5 mg.
• Designed for middle-of-the-night awakenings when ≥4 hours remain.

Special Populations

• Elderly or debilitated: Use lowest effective dose (5 mg IR, 6.25 mg CR).
• Hepatic impairment: Same reduced doses; avoid use in severe cases.
• Renal impairment: Standard dosing; monitor for sensitivity.
• Pediatrics (<18 years): Not recommended.
• Duration: Short-term, generally no longer than 2–6 weeks with periodic reassessment.

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Zolpidem selectively binds the benzodiazepine site on GABA_A receptors (particularly the alpha-1 subtype), enhancing inhibitory GABA activity in the brain. This leads to reduced time to fall asleep and supports sleep initiation by calming neuronal signaling involved in arousal.

• Absorption: ~70% bioavailability; onset within 30 minutes.
• Distribution: ~92% protein-bound.
• Metabolism: Primarily by hepatic CYP3A4, CYP2C9, CYP1A2; minor CYP2D6 and CYP2C19 involvement.
• Elimination half-life: 2–3 hours in healthy adults; prolonged in elderly or those with hepatic impairment (can reach 9–10 hours).
• Excretion: Mostly as metabolites via urine (56%) and feces (34%); <1% excreted unchanged.
• Note: Extended-release forms prolong therapeutic levels while maintaining similar kinetics.

• Pregnancy: No sufficient human studies; potential risks at high doses in animal models. Use only if benefits outweigh potential risks.
• Lactation: Zolpidem transfers into breast milk; may cause sedation or respiratory depression in infants. If necessary, use the lowest effective dose and avoid timing feedings around dosing.

• Class: Sedative-hypnotic.
• Subclass: Non-benzodiazepine “Z‑drug” (Imidazopyridine—selective GABA_A modulator).

• Known allergy to zolpidem.
• History of complex sleep behaviors (e.g., sleep-driving, sleep-walking).
• Severe hepatic impairment.
• Use with strong CYP3A4 inhibitors at high doses (requires caution).

• Complex Sleep Behaviors: Possible activities performed during sleep without memory—discontinue if they occur.
• Daytime Impairment: Next-day drowsiness, especially with higher doses or insufficient sleep.
• CNS Depression: Monitor when used with opioids, alcohol, or other sedatives.
• Respiratory Risk: In COPD, sleep apnea, or other respiratory compromise.
• Allergic or Psychiatric Reactions: Rare occurrences include hallucinations or depression.
• Dependence/Withdrawal: Risk increases with prolonged use—taper gradually.

Common (dose-related)

• Dizziness, headache, drowsiness, impaired coordination, nausea.

Less Common

• Gastrointestinal symptoms, memory impairment, irritability, hallucinations.

Serious (rare)

• Complex sleep behaviors, severe allergic reactions (anaphylaxis), respiratory depression, suicidal ideation, withdrawal symptoms like anxiety or rebound insomnia.

• CNS Depressants: Additive sedation with opioids, benzodiazepines, alcohol.
• CYP3A4 Inhibitors (e.g., ketoconazole, clarithromycin): Increase zolpidem level and sedation.
• CYP3A4 Inducers (e.g., carbamazepine, rifampin): May reduce effectiveness.
• Food delays absorption; avoid heavy meals before dosing.
• Minimal interactions otherwise; not significantly metabolized by CYP2C19/2D6.

• Dosing Requirements: Lower recommendations for women established in 2013.
• Safety Warnings: Boxed warnings added for complex sleep behaviors and next-day impairment (2019).
• Clinical Guidelines: Major sleep societies now emphasize short-term use and integration of behavioral therapy.
• Regulatory Emphasis: Cautionary labeling regarding next-day driving, especially with extended-release forms or higher doses.

• Store at room temperature (20–25 °C, with acceptable range 15–30 °C).
• Keep away from moisture, heat, and direct sunlight.
• Store tablets/capsules in a tightly sealed container and out of children’s reach.
• Do not refrigerate or freeze.
• For spray formulations, keep upright and at room temperature.