• Esilgan indications
• Uses of Esilgan in details
• Esilgan description
• Esilgan dosage
• Esilgan interactions
• Esilgan side effects
• Esilgan contraindications

What is Esilgan?

Esilgan is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Esilgan affects chemicals in the brain that may become unbalanced and cause sleep problems (insomnia).

Esilgan is used to treat insomnia symptoms, such as trouble falling or staying asleep.

Esilgan may also be used for purposes other than those listed in this medication guide.

Esilgan indications

Esilgan (Esilgan) is indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. Both outpatient studies and a sleep laboratory study have shown that Esilgan (Esilgan) administered at bedtime improved sleep induction and sleep maintenance.

Because insomnia is often transient and intermittent, the prolonged administration of Esilgan (Esilgan) is generally neither necessary nor recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered.

There is evidence to support the ability of Esilgan (Esilgan) to enhance the duration and quality of sleep for intervals up to 12 weeks.

How should I use Esilgan?

Use Esilgan as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Esilgan by mouth with or without food.
• Take Esilgan at bedtime.
• If you miss a dose of Esilgan, take it as soon as possible. If you no longer have time for a full night's sleep or you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Esilgan.

Uses of Esilgan in details

Use: Labeled Indications

Insomnia: Short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.

Esilgan description

A benzodiazepine with anticonvulsant, hypnotic, and muscle relaxant properties. It has been shown in some cases to be more potent than diazepam or nitrazepam. [PubChem]

Esilgan dosage

Esilgan Dosage

Generic name: Esilgan

Dosage form: Tablets CS-IV

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

The recommended initial dose for adults is 1 mg at bedtime; however, some patients may need a 2 mg dose. In healthy elderly patients, 1 mg is also the appropriate starting dose, but increases should be initiated with particular care. In small or debilitated older patients, a starting dose of 0.5 mg, while only marginally effective in the overall elderly population, should be considered.

More about Esilgan (Esilgan)

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Consumer resources

• Esilgan
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Professional resources

• Esilgan (FDA)
• Esilgan (AHFS Monograph)

Related treatment guides

• Insomnia

Esilgan interactions

See also:
What other drugs will affect Esilgan?

If Esilgan (Esilgan) is given concomitantly with other drugs acting on the central nervous system, careful consideration should be given to the pharmacology of all agents. The action of the benzodiazepines may be potentiated by anticonvulsants, antihistamines, alcohol, barbiturates, monoamine oxidase inhibitors, narcotics, phenothiazines, psychotropic medications, or other drugs that produce CNS depression. Smokers have an increased clearance of benzodiazepines as compared to nonsmokers; this was seen in studies with Esilgan.

While no in vivo drug-drug interaction studies were conducted between Esilgan and inducers of CYP3A, compounds that are potent CYP3A inducers (such as carbamazepine, phenytoin, rifampin, and barbiturates) would be expected to decrease Esilgan concentrations.

Esilgan Interaction with Drugs that Inhibit Metabolism via Cytochrome P450 3A (CYP3A): The metabolism of Esilgan to the major circulating metabolite 4-hydroxy-Esilgan and the metabolism of other triazolobenzodiazepines is catalyzed by CYP3A. Consequently, Esilgan should be avoided in patients receiving ketoconazole and itraconazole, which are very potent inhibitors of CYP3A. With drugs inhibiting CYP3A to a lesser, but still significant degree, Esilgan should be used only with caution and consideration of appropriate dosage reduction. The following are examples of drugs known to inhibit the metabolism of other related benzodiazepines, presumably through inhibition of CYP3A: nefazodone, fluvoxamine, cimetidine, diltiazem, isoniazide, and some macrolide antibiotics.

Drug Interaction with Fluoxetine: A multiple-dose study was conducted to assess the effect of fluoxetine 20 mg BID on the pharmacokinetics of Esilgan 2 mg QHS after seven days. The pharmacokinetics of Esilgan (Cmax and AUC) were not affected during multiple-dose fluoxetine, suggesting no clinically significant pharmacokinetic interaction.

Esilgan Interaction with Other Drugs that are Metabolized by Cytochrome P450 (CYP): At clinically relevant concentrations, in vitro studies indicate that Esilgan (0.6

Esilgan side effects

See also:
What are the possible side effects of Esilgan?

Commonly Observed: The most commonly observed adverse events associated with the use of Esilgan (Esilgan), not seen at an equivalent incidence among placebo-treated patients were somnolence, hypokinesia, dizziness, and abnormal coordination.

Associated with Discontinuation of Treatment: Approximately 3% of 1277 patients who received Esilgan (Esilgan) in US premarketing clinical trials discontinued treatment because of an adverse clinical event. The only event commonly associated with discontinuation, accounting for 1.3% of the total, was somnolence.

Incidence in Controlled Clinical Trials: The table below enumerates adverse events that occurred at an incidence of 1% or greater among patients with insomnia who received Esilgan (Esilgan) in 7-night, placebo-controlled trials. Events reported by investigators were classified into standard dictionary (COSTART) terms to establish event frequencies. Event frequencies reported were not corrected for the occurrence of these events at baseline. The frequencies were obtained from data pooled across six studies: Esilgan (Esilgan), N=685; placebo, N=433. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice in which patient characteristics and other factors differ from those that prevailed in these six clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigators involving related drug products and uses, since each group of drug trials was conducted under a different set of conditions. However, the cited figures provide the physician with a basis of estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the population studied.

INCIDENCE OF ADVERSE EXPERIENCES IN PLACEBO-CONTROLLED CLINICAL TRIALS (Percentage of Patients Reporting)

Other Adverse Events

During clinical trials conducted by Abbott, some of which were not placebo-controlled, Esilgan (Esilgan) was administered to approximately 1300 patients. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals experiencing adverse events, similar types of untoward events must be grouped into a smaller number of standardized event categories. In the tabulations that follow, a standard COSTART dictionary terminology has been used to classify reported adverse events. Thefrequencies presented, therefore, represent the proportion of the 1277 individuals exposed to Esilgan (Esilgan) who experienced an event of the type cited on at least one occasion while receiving Esilgan (Esilgan). All reported events are included except those already listed in the previous table, those COSTART terms too general to be informative, and those events where a drug cause was remote. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in less than 1/1000 patients. It is important to emphasize that, although the events reported did occur during treatment with Esilgan (Esilgan), they were not necessarily caused by it.

Body as a Whole - Infrequent: allergic reaction, chills, fever, neck pain, upper extremity pain; Rare: edema, jaw pain, swollen breast.

Cardiovascular System - Infrequent: flushing, palpitation; Rare: arrhythmia, syncope.

Digestive System - Frequent: constipation, dry mouth; Infrequent: decreased appetite, flatulence, gastritis, increased appetite, vomiting; Rare: enterocolitis, melena, ulceration of the mouth.

Endocrine System - Rare: thyroid nodule.

Hematologic and Lymphatic System - Rare: leukopenia, purpura, swollen lymph nodes.

Metabolic/Nutritional Disorders - Infrequent: thirst; Rare: increased SGOT, weight gain, weight loss.

Musculoskeletal System - Infrequent: arthritis, muscle spasm, myalgia; Rare: arthralgia.

Nervous System - Frequent: anxiety; Infrequent: agitation, amnesia, apathy, emotional lability, euphoria, hostility, paresthesia, seizure, sleep disorder, stupor, twitch; Rare: ataxia, circumoral paresthesia, decreased libido, decreased reflexes, hallucinations, neuritis, nystagmus, tremor.

Minor changes in EEG patterns, usually low-voltage fast activity, have been observed in patients during Esilgan (Esilgan) therapy or withdrawal and are of no known clinical significance.

Respiratory System- Infrequent: asthma, cough, dyspnea, rhinitis, sinusitis; Rare: epistaxis, hyperventilation, laryngitis.

Skin and Appendages - Infrequent: rash, sweating, urticaria; Rare: acne, dry skin.

Special Senses - Infrequent: abnormal vision, ear pain, eye irritation, eye pain, eye swelling, perverse taste, photophobia, tinnitus; Rare: decreased hearing, diplopia, scotomata.

Urogenital System - Infrequent: frequent urination, menstrual cramps, urinary hesitancy, urinary urgency, vaginal discharge/itching; Rare: hematuria, nocturia, oliguria, penile discharge, urinary incontinence.

Postintroduction Reports - Voluntary reports of non-US postmarketing experience with Esilgan have included rare occurrences of photosensitivity, Stevens-Johnson syndrome, and agranulocytosis. Because of the uncontrolled nature of these spontaneous reports, a causal relationship to Esilgan treatment has not been determined.

Drug Abuse And Dependence

Controlled Substance: Esilgan (Esilgan) tablets are a controlled substance in Schedule IV.

Abuse and Dependence: Withdrawal symptoms similar to those noted with sedatives/hypnotics and alcohol have occurred following the abrupt discontinuation of drugs in the benzodiazepine class. The symptoms can range from mild dysphoria and insomnia to a major syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions.

Although withdrawal symptoms are more commonly noted after the discontinuation of higher than therapeutic doses of benzodiazepines, a proportion of patients taking benzodiazepines chronically at therapeutic doses may become physically dependent on them. Available data, however, cannot provide a reliable estimate of the incidence of dependency or the relationship of the dependency to dose and duration of treatment. There is some evidence to suggest that gradual reduction of dosage will attenuate or eliminate some withdrawal phenomena. In most instances, withdrawal phenomena are relatively mild and transient; however, life-threatening events (eg, seizures, delirium, etc.) have been reported.

Gradual withdrawal is the preferred course for any patient taking benzodiazepines for a prolonged period. Patients with a history of seizures, regardless of their concomitant antiseizure drug therapy, should not be withdrawn abruptly from benzodiazepines.

Individuals with a history of addiction to or abuse of drugs or alcohol should be under careful surveillance when receiving benzodiazepines because of the risk of habituation and dependence to such patients.

Esilgan contraindications

See also:
What is the most important information I should know about Esilgan?

Esilgan may cause a severe allergic reaction. Stop taking Esilgan and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Take Esilgan only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Esilgan and talk with your doctor about another treatment for your sleep disorder.

Do not use this medication if you are allergic to Esilgan or to other benzodiazepines, such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), temazepam (Restoril), or triazolam (Halcion).

This medication can cause birth defects in an unborn baby, or withdrawal symptoms in a newborn. Do not use Esilgan if you are pregnant.

Esilgan may be habit-forming and should be used only by the person it was prescribed for.Keep the medication in a secure place where others cannot get to it.

Active ingredient matches for Esilgan:

Estazolam in Indonesia, Italy, Philippines.

References

1. DailyMed. "ESTAZOLAM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "estazolam". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "estazolam". http://www.drugbank.ca/drugs/DB01215 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology