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Zolpidem Tartrate is a sedative-hypnotic medication chemically unrelated to benzodiazepines; it belongs to the imidazopyridine class. It binds to GABA-A receptors in the brain, reducing excessive neuronal excitation and promoting sleep. Zolpidem Tartrate Capsules are available only in the 7.5 mg strength; another immediate-release zolpidem product should be used for 5 mg or 10 mg dosing.

Short-term (transient) insomnia characterized by difficulty with sleep initiation, in adults younger than 65 years. Generally not used for more than 7-10 consecutive days; if insomnia persists beyond this, re-evaluation by a physician is required.

Miscellaneous sedatives & hypnotics

Non-benzodiazepine GABA-A receptor positive modulator (imidazopyridine class)

Zolpidem binds to the benzodiazepine site of GABA-A receptors, with greater affinity for alpha1 subunit-containing receptors compared to alpha2 and alpha3 subunits. It has no appreciable binding affinity for alpha5 subunit-containing receptors, which may explain the relatively low myorelaxant effect observed in animal studies. It does not bind appreciably to dopaminergic D2, serotonergic 5HT2, adrenergic, histaminergic, or muscarinic receptors.

Zolpidem increases the frequency of chloride channel opening, enhancing the inhibitory effect of GABA, which reduces neuronal excitation and promotes sleep onset. It shortens sleep latency and improves overall sleep duration, while having relatively minimal impact on REM and slow-wave sleep stages. After oral administration it is absorbed rapidly and is metabolized primarily in the liver via CYP3A4 into inactive metabolites, eliminated mainly through urine and, to a lesser extent, feces.

Zolpidem Tartrate Capsules are available only in the 7.5 mg strength. Use in geriatric patients should be avoided. Females: starting dosage 5 mg once nightly. Males: starting dosage may be 5 mg, 7.5 mg, or 10 mg once nightly. If 5 mg is not effective, dosage may be increased to 7.5 mg or 10 mg. Maximum recommended dosage: 10 mg once nightly. Intended for short-term use only.

Take orally once per night, immediately before bedtime. At least 7 to 8 hours of sleep time should remain after taking the dose. Should not be taken with or immediately after a meal. Swallow the capsule whole - do not open, crush, or chew. Lower doses of CNS depressants may be necessary when taken concomitantly.

This medicine is taken only as needed at night, so there is no fixed missed dose schedule. If a dose is missed, resume the regular dosing schedule at the next appropriate time. Never take a double dose to make up for a missed one, as this increases the risk of overdose.

The most commonly observed adverse reactions are headache, drowsiness, dizziness, and diarrhea. Complex sleep behaviors CNS-depressant effects and next-day impairment Severe anaphylactic and angioedema reactions Abnormal thinking and behavior changes Withdrawal effects upon discontinuation

Alertness and motor coordination may be impaired, especially the morning after use. If insomnia persists after 7-10 days of use, re-evaluation is needed. Do not rechallenge if severe allergic reactions occur. New onset behavioral changes, depression, or suicidal thoughts require immediate medical evaluation. Use caution in patients with compromised respiratory function or severe hepatic impairment. Withdrawal effects may occur with rapid dose reduction or abrupt discontinuation.

Patients who have experienced complex sleep behaviors after taking zolpidem Patients with known hypersensitivity to zolpidem, including anaphylaxis or angioedema

CNS depressants (including alcohol): may cause additive effects. Opioids: may increase the risk of respiratory depression. Imipramine: may cause decreased alertness. Chlorpromazine: may impair alertness and psychomotor performance. CYP3A4 inducers: may decrease effects. CYP3A4 inhibitors: may increase effects.

Taking this medicine with or immediately after a meal may delay its onset of action. It is best taken on an empty stomach, right before bedtime.

A pregnancy exposure registry monitors outcomes in women exposed to psychiatric medications during pregnancy. Data on the safety of zolpidem use during pregnancy are limited, so it should not be used without a physician's advice.

Pregnancy Category: C — always consult a doctor before taking during pregnancy.

Limited published data indicate that zolpidem is present in human breast milk, with reports of excess sedation in breastfed infants. Breastfeeding mothers should consult a physician before using this medicine.

Safety and effectiveness in children have not been established. In a study of pediatric patients with ADHD, hallucinations (incidence approximately 7%) and other psychiatric/nervous system adverse reactions were observed frequently.

Zolpidem Tartrate Capsules are not indicated for patients over 65 years of age. Because the necessary dosage adjustment is not possible with the available 7.5 mg strength, use in geriatric patients should be avoided.

Zolpidem is metabolized primarily in the liver into inactive metabolites, eliminated mainly through urine. In patients with severe hepatic impairment, this medicine should be avoided due to the risk of hepatic encephalopathy. Dosage in renal impairment should be determined under medical supervision.

Taking more than the prescribed dose, or combining it with alcohol or other CNS depressants, can lead to severe respiratory depression and unconsciousness. Overdose symptoms include severe drowsiness, severe nausea or vomiting, staggering, and difficulty breathing. Seek emergency medical care immediately if overdose is suspected. Hospital treatment is generally supportive; flumazenil may be used in certain cases under medical supervision.

Store below 30C, away from light and moisture. Keep out of the reach of children.

Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a]pyridine-3-acetamide, used as the L-(+)-tartrate salt (2:1 ratio). It is a white to off-white crystalline powder, sparingly soluble in water, alcohol, and propylene glycol. Molecular formula C42H48N6O8, molecular weight approximately 764.88.

Q: How long can I take Zolpidem Tartrate Capsules? A: It is intended only for short-term use, typically not more than a few weeks. If longer treatment is needed, consult your doctor for re-evaluation. Q: Can I take this medicine with food? A: No, taking it with or right after a meal may delay its effect. It should be taken on an empty stomach, right before bedtime. Q: Can elderly patients take this capsule? A: No, this 7.5 mg capsule is not recommended for patients over 65, as it does not allow the necessary dosage adjustment. Q: Can pregnant or breastfeeding women take this medicine? A: This medicine should not be taken during pregnancy or breastfeeding without a doctor's advice, as it can pass into breast milk and affect the infant. Q: What should I do in case of overdose? A: If you notice severe drowsiness, breathing difficulty, or loss of consciousness, seek emergency medical help immediately.