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eszopiclone
Overview
What is eszopiclone?
Eszopiclone Tablets are a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.81, and its empirical formula is CHClNO. Eszopiclone has a single chiral center with an ()-configuration. It has the following chemical structure:
Eszopiclone is a white to slightly yellowish crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2).
Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone Tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose (anhydrous), magnesium stearate, microcrystalline cellulose and Opadry II (White). Opadry II (White) contains hypromellose, polydextrose, polyethylene glycol, titanium dioxide and triacetin.
What does eszopiclone look like?
What are the available doses of eszopiclone?
Tablets: 1 mg, 2 mg and 3 mg tablets ()
What should I talk to my health care provider before I take eszopiclone?
How should I use eszopiclone?
Eszopiclone Tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, Eszopiclone Tablets administered at bedtime decreased sleep latency and improved sleep maintenance.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).
Use the lowest effective dose for the patient.
What interacts with eszopiclone?
Sorry No Records found
What are the warnings of eszopiclone?
Sorry No Records found
What are the precautions of eszopiclone?
Sorry No Records found
What are the side effects of eszopiclone?
Sorry No records found
What should I look out for while using eszopiclone?
Eszopiclone Tablets are contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema.
What might happen if I take too much eszopiclone?
In clinical trials with eszopiclone, one case of overdose with up to 36 mg of eszopiclone was reported in which the subject fully recovered. Since commercial marketing began, spontaneous cases of eszopiclone overdoses up to 270 mg (90 times the maximum recommended dose of eszopiclone) have been reported, in which patients have recovered. Fatalities related to eszopiclone overdoses were reported only in combination with other CNS drugs or alcohol.
How should I store and handle eszopiclone?
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.Product: 71335-0784NDC: 71335-0784-1 30 TABLET in a BOTTLENDC: 71335-0784-2 60 TABLET in a BOTTLENDC: 71335-0784-3 90 TABLET in a BOTTLENDC: 71335-0784-4 120 TABLET in a BOTTLENDC: 71335-0784-5 20 TABLET in a BOTTLENDC: 71335-0784-6 28 TABLET in a BOTTLEProduct: 71335-0784NDC: 71335-0784-1 30 TABLET in a BOTTLENDC: 71335-0784-2 60 TABLET in a BOTTLENDC: 71335-0784-3 90 TABLET in a BOTTLENDC: 71335-0784-4 120 TABLET in a BOTTLENDC: 71335-0784-5 20 TABLET in a BOTTLENDC: 71335-0784-6 28 TABLET in a BOTTLEProduct: 71335-0784NDC: 71335-0784-1 30 TABLET in a BOTTLENDC: 71335-0784-2 60 TABLET in a BOTTLENDC: 71335-0784-3 90 TABLET in a BOTTLENDC: 71335-0784-4 120 TABLET in a BOTTLENDC: 71335-0784-5 20 TABLET in a BOTTLENDC: 71335-0784-6 28 TABLET in a BOTTLEProduct: 71335-0784NDC: 71335-0784-1 30 TABLET in a BOTTLENDC: 71335-0784-2 60 TABLET in a BOTTLENDC: 71335-0784-3 90 TABLET in a BOTTLENDC: 71335-0784-4 120 TABLET in a BOTTLENDC: 71335-0784-5 20 TABLET in a BOTTLENDC: 71335-0784-6 28 TABLET in a BOTTLEProduct: 71335-0784NDC: 71335-0784-1 30 TABLET in a BOTTLENDC: 71335-0784-2 60 TABLET in a BOTTLENDC: 71335-0784-3 90 TABLET in a BOTTLENDC: 71335-0784-4 120 TABLET in a BOTTLENDC: 71335-0784-5 20 TABLET in a BOTTLENDC: 71335-0784-6 28 TABLET in a BOTTLEProduct: 71335-0784NDC: 71335-0784-1 30 TABLET in a BOTTLENDC: 71335-0784-2 60 TABLET in a BOTTLENDC: 71335-0784-3 90 TABLET in a BOTTLENDC: 71335-0784-4 120 TABLET in a BOTTLENDC: 71335-0784-5 20 TABLET in a BOTTLENDC: 71335-0784-6 28 TABLET in a BOTTLEProduct: 71335-0784NDC: 71335-0784-1 30 TABLET in a BOTTLENDC: 71335-0784-2 60 TABLET in a BOTTLENDC: 71335-0784-3 90 TABLET in a BOTTLENDC: 71335-0784-4 120 TABLET in a BOTTLENDC: 71335-0784-5 20 TABLET in a BOTTLENDC: 71335-0784-6 28 TABLET in a BOTTLE
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The precise mechanism of action of eszopiclone as a hypnotic is unknown, but its effect is believed to result from its interaction with GABA-receptor complexes at binding domains located close to or allosterically coupled to benzodiazepine receptors. Eszopiclone is a nonbenzodiazepine hypnotic that is a pyrrolopyrazine derivative of the cyclopyrrolone class with a chemical structure unrelated to pyrazolopyrimidines, imidazopyridines, benzodiazepines, barbiturates, or other drugs with known hypnotic properties.
Non-Clinical Toxicology
Eszopiclone Tablets are contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema.Use with Opioids
Use with Other CNS Depressants
Use with Imipramine and Desipramine
Drugs that inhibit alprazolam metabolism via cytochrome P450 3A
Drugs demonstrated to be CYP3A inhibitors of possible clinical significance on the basis of clinical studies involving alprazolam (caution is recommended during coadministration with alprazolam)
Fluoxetine—Coadministration of fluoxetine with alprazolam increased the maximum plasma concentration of alprazolam by 46%, decreased clearance by 21%, increased half-life by 17%, and decreased measured psychomotor performance.
Propoxyphene—Coadministration of propoxyphene decreased the maximum plasma concentration of alprazolam by 6%, decreased clearance by 38%, and increased half-life by 58%.
Oral Contraceptives—Coadministration of oral contraceptives increased the maximum plasma concentration of alprazolam by 18%, decreased clearance by 22%, and increased half-life by 29%.
Drugs and other substances demonstrated to be CYP3A inhibitors on the basis of clinical studies involving benzodiazepines metabolized similarly to alprazolam or on the basis of studies with alprazolam or other benzodiazepines (caution is recommended during coadministration with alprazolam)
Available data from clinical studies of benzodiazepines other than alprazolam suggest a possible drug interaction with alprazolam for the following: diltiazem, isoniazid, macrolide antibiotics such as erythromycin and clarithromycin, and grapefruit juice. Data from studies of alprazolam suggest a possible drug interaction with alprazolam for the following: sertraline and paroxetine. However, data from an drug interaction study involving a single dose of alprazolam 1 mg and steady state dose of sertraline (50 to 150 mg/day) did not reveal any clinically significant changes in the pharmacokinetics of alprazolam. Data from studies of benzodiazepines other than alprazolam suggest a possible drug interaction for the following: ergotamine, cyclosporine, amiodarone, nicardipine, and nifedipine. Caution is recommended during the coadministration of any of these with alprazolam (see ).
Drugs demonstrated to be inducers of CYP3A
Eszopiclone is a central nervous system (CNS) depressant and can impair daytime function in some patients at the higher doses (2 mg or 3 mg), even when used as prescribed. Prescribers should monitor for excess depressant effects, but impairment can occur in the absence of symptoms (or even with subjective improvement), and impairment may not be reliably detected by ordinary clinical exam (i.e., less than formal psychomotor testing). While pharmacodynamic tolerance or adaptation to some adverse depressant effects of eszopiclone may develop, patients using 3 mg eszopiclone should be cautioned against driving or engaging in other hazardous activities or activities requiring complete mental alertness the day after use.
Additive effects occur with concomitant use of other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol), including daytime use. Downward dose adjustment of eszopiclone and concomitant CNS depressants should be considered
The use of eszopiclone with other sedative-hypnotics at bedtime or the middle of the night is not recommended.
The risk of next-day psychomotor impairment is increased if eszopiclone is taken with less than a full night of sleep remaining (7 to 8 hours); if higher than the recommended dose is taken; if co- administered with other CNS depressants; or co-administered with other drugs that increase the blood levels of eszopiclone
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The premarketing development program for eszopiclone included eszopiclone exposures in patients and/or normal subjects from two different groups of studies: approximately 400 normal subjects in clinical pharmacology/pharmacokinetic studies, and approximately 1550 patients in placebo-controlled clinical effectiveness studies, corresponding to approximately 263 patient-exposure years. The conditions and duration of treatment with eszopiclone varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, and short-term and longer-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.
The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while the patient was receiving therapy following baseline evaluation.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
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