Edluar (zolpidem tartrate)

The lowest effective dosage of zolpidem tartrate should be used. Long-term use of zolpidem is not recommended; treatment duration should be as short as possible. Extended treatment should not take place without re-evaluation of the patient's status; risk of abuse and dependence increases with the duration of treatment.

The recommended initial doses of zolpidem tartrate for women and men differ because clearance of the drug is slower in women.

Because manifestations of withdrawal have been reported following abrupt discontinuance or rapid reduction in dosage of zolpidem, patients should be monitored for tolerance, abuse, and dependence. There also is evidence that abrupt discontinuance of sedative and hypnotic drugs, including zolpidem tartrate, may result in rebound insomnia, which usually persists for 1 or 2 nights; this effect may occur with some sedative and hypnotic drugs even after relatively short periods of therapy (e.g., 1 week). Therefore, some clinicians suggest that gradual dosage reduction (e.g., over several nights) be considered when discontinuing therapy, since the development of rebound insomnia can perpetuate continued use of hypnotics in patients with insomnia.

Zolpidem tartrate is administered orally (as conventional tablets or extended-release tablets) or sublingually (as sublingual tablets).

No dosing information is available for this tab.

No dosing information is available for this tab.

Zolpidem is metabolized principally by cytochrome P-450 (CYP) isoenzyme 3A4 and, to a lesser extent, by CYP1A2 and CYP2D6.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*History of a complex sleep behavior while taking eszopiclone, zaleplon, or zolpidem.

*Known hypersensitivity to zolpidem.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Zolpidem tartrate conventional tablets generally are well tolerated at recommended doses (i.e., up to 10 mg). Adverse effects of the drug tend to be dose-related, particularly in geriatric patients and at doses exceeding those recommended. The most common adverse reactions with zolpidem conventional tablets when used in the short-term (<10 nights) include drowsiness, dizziness, and diarrhea; common adverse reactions reported with long-term use (28-35 nights) of the conventional tablets include dizziness and drugged feeling.

Adverse effects of zolpidem tartrate as extended-release tablets tend to be dose-related, particularly for certain adverse nervous system and GI effects. The most common adverse effects of zolpidem tartrate as extended-release tablets (occurring in >10% of adult patients) include headache, next-day somnolence, and dizziness.

The incidence of adverse effects in patients receiving zolpidem tartrate as 1.75- or 3.5-mg sublingual tablets were headache, fatigue, and nausea.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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Zolpidem tartrate is not recommended for use in pediatric patients. Safety and efficacy of the drug have not been established in pediatric patients younger than 18 years of age. In an 8-week clinical study in pediatric patients (6-17 years of age) with insomnia associated with attention deficit hyperactivity disorder (ADHD), zolpidem tartrate (0.25 mg/kg administered as an oral solution at bedtime) did not appear to decrease sleep latency as compared with placebo. In this study, the most frequent treatment-emergent adverse effects (compared with placebo) were nervous system effects, including dizziness (23.5 versus 1.5%), headache (12.5 versus 9.2%), and hallucinations (7 versus 0%).

Published data from observational studies, birth registries, and case reports do not report a clear association between use of zolpidem and major birth defects. There are limited postmarketing reports of moderate to severe neonatal respiratory depression requiring artificial ventilation or intratracheal intubation when zolpidem was used late in the third trimester of pregnancy; the majority of neonates recovered within hours to a few weeks after birth once treated.

Zolpidem crosses the placenta and may cause respiratory depression and sedation in neonates. Neonates exposed to zolpidem during pregnancy and labor should be monitored for signs of excess sedation, hypotonia, and respiratory depression and treated as clinically appropriate.

Reproduction studies in animals were performed using zolpidem rather than zolpidem tartrate; dosages are expressed in terms of the base. Administration of zolpidem to pregnant rats and rabbits resulted in adverse effects on offspring development at dosages exceeding the maximum recommended human dosage (MRHD) of zolpidem tartrate as conventional tablets (10 mg daily); however, teratogenicity was not observed. When zolpidem was administered at oral dosages of 4, 20, and 100 mg/kg daily to pregnant rats during the period of organogenesis, delayed fetal development (incomplete fetal skull ossification) occurred at all but the lowest dosage (4 mg/kg daily, which is approximately 5 times the MRHD of zolpidem tartrate as conventional tablets on a mg/m2 basis). In addition, administration of zolpidem to rats at oral dosages of 4, 20, and 100 mg/kg daily from day 15 of gestation through lactation delayed offspring growth and decreased survival at all but the lowest dosage. In rabbits receiving zolpidem during organogenesis at oral dosages of 1, 4, and 16 mg/kg daily, increased embryofetal death and incomplete fetal skeletal ossification occurred at the highest dosage studied. No risk of adverse effects on fetal development was observed following oral administration of zolpidem to pregnant rats and rabbits at clinically relevant doses.

Zolpidem is distributed into milk in small amounts in humans. Excess sedation has been reported in nursing infants exposed to zolpidem through breast milk. The effects of zolpidem on milk production are not known.

Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for zolpidem and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition. Infants exposed to zolpidem through breast milk should be monitored for excess sedation, hypotonia, and respiratory depression. Nursing women may consider interrupting breast-feeding and pumping and discarding breast milk during treatment and for 23 hours after administration of zolpidem to minimize drug exposure to a breast-fed infant.

Safety and efficacy of zolpidem for the treatment of insomnia in geriatric patients have been evaluated in controlled, double-blind studies. Geriatric or debilitated patients may be particularly sensitive to the effects of zolpidem. Adverse effects of the drug tend to be dose-related, particularly in geriatric patients. In addition, peak plasma zolpidem concentrations, elimination half-life, and AUC are increased substantially in geriatric patients compared with younger adults receiving zolpidem tartrate as conventional tablets.

In placebo-controlled clinical trials in geriatric patients receiving zolpidem tartrate doses of 10 mg or less (as conventional tablets), the most frequent adverse effects were dizziness, drowsiness, and diarrhea. In placebo-controlled clinical trials in geriatric patients receiving zolpidem tartrate 6.25 mg as extended-release tablets, the most frequent adverse effects were headache, dizziness, and next-day somnolence. In clinical trials performed outside the US, involving approximately 2000 patients, falls were reported in about 1.5% of patients (93% of those being 70 years of age or older); 82% of the patients 70 years of age or older who experienced falls received zolpidem tartrate doses exceeding 10 mg (as conventional tablets). In these clinical trials, confusion was reported in 1.2% of patients (75% of those being 70 years of age or older); 78% of the patients 70 years of age or older who experienced confusion were receiving doses exceeding 10 mg (as conventional tablets).

The manufacturers recommend that zolpidem dosage be reduced in geriatric and/or debilitated patients to minimize adverse effects related to impaired motor and/or cognitive performance and unusual sensitivity to sedative and hypnotic drugs. Sedatives may cause confusion and oversedation in geriatric patients; geriatric patients should be observed closely. Geriatric patients are at a higher risk of falls related to drowsiness and CNS depression caused by zolpidem.