Zopilone

Introduction
Zopilone is a prescription medicine used to treat insomnia. It reduces sleep onset time and frequent awakening at night. This medicine improves sleep maintenance and therefore ensures sound sleep. Zopilone should be taken on an empty stomach, preferably before going to bed. However, it is advised to take it at the same time each day as this helps to maintain a consistent level of medicine in the body. Take this medicine in the dose and duration as advised by your doctor as it is habit forming. Do not stop taking it suddenly without talking to your doctor as it may worsen your symptoms. Some common side effects of this medicine include headache, taste changes, dry mouth, rash, anxiety, respiratory tract infections or viral infections. However, these are temporary and resolve on their own after some time. It also causes dizziness and sleepiness, so do not drive or do anything that requires mental focus until you know how this medicine affects you and do not take alcohol with it as it may worsen the dizziness. Inform your doctor if you develop any unusual changes in mood or behavior, new or worsening depression, hallucinations or suicidal thoughts while taking this medicine. Consult your doctor before taking this medicine if you are suffering from any liver or kidney problems. You should avoid smoking and alcohol while using this medicine. Pregnant and breastfeeding mothers should not use this medicine. However, if the need arises, please consult your doctor before using it.

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Uses of Zopilone
Insomnia
Side effects of Zopilone
Common
Sleepiness
Dizziness
Headache
Taste change
Dryness in mouth
Rash
Anxiety
Hallucination
Respiratory tract infection
Viral infection
How to use Zopilone
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Zopilone is to be taken empty stomach.
How Zopilone works
Zopilone belongs to a group of medicines called sedative-hypnotics. It works by slowing activity of the nerve cells in the brain and helps fall asleep.
Quick Tips
Your doctor has prescribed ZOLNITE 2 MG TABLET to help you fall asleep faster and sleep for longer.
It is best taken without food as a high-fat meal can reduce its absorption and effect.
Take it 30 to 45 minutes before bedtime and only when you have time to sleep for at least 7 hours.
It makes you feel dizzy next morning. Don’t drive or do anything requiring concentration until you know how it affects you.
It does not affect total sleep time. However, it reduces sleep onset time and frequent awakening at night.
Never share your medication with any other person who also has a sleep problem.
Inform your doctor if your sleep doesn’t improve after 7 to 10 days of treatment.
Stop taking medication and inform your doctor If you experience sleep driving or memory loss.
Inform your doctor if you notice behavioral changes, new or worsening depression or suicidal thoughts.
Inform your doctor if you are pregnant, planning pregnancy or breastfeeding.
Inform your doctor if you have a history of depression, drug/alcohol abuse, and liver disease.
Do not stop taking medication suddenly as it may lead to anxiety, mood changes, and restlessness.
Brief Description
Indication
Insomnia
Administration
Should be taken on an empty stomach. Take immediately before going to bed. Avoid taking after a heavy meal.
Adult Dose
Oral Insomnia Adult: 1 mg immediately before bedtime, may increase to 2 or 3 mg if necessary. Max: 3 mg daily. Elderly: Max: 2 mg daily. Hepatic impairment: Severe: Max: 2 mg daily.

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Child Dose
Safety and efficacy not established
Contraindication
Hypersensitivity
Mode of Action
Eszopiclone is an S-enantiomer of zopiclone; a nonbenzodiazepine hypnotic of the cyclopyrrolone class. It is structurally unrelated to pyrazolopyrimidines, imidazopyridines, benzodiazepines, barbiturates, or other known drugs with similar hypnotic activity. The exact mechanism of action is unknown, its effect is associated with the interaction with gamma-aminobutyric acid (GABA)-receptor complex at binding domains found near to or allosterically coupled to benzodiazepine receptors.
Precaution
Initiate treatment only after careful evaluation of patients; failure of insomnia to remit after 7-10 days of treatment may indicate presence of primary psychiatric and/or medical illness requiring evaluation. May be associated with abnormal thoughts and behaviour changes e.g. bizarre behavior, agitation, hallucinations, depersonalization, decreased inhibition. Complex sleep-related behaviours with no memory of the incident such as “sleep-driving”, preparing and eating food, making phone calls, having sex while not fully awake have been reported. Caution in patients with history of drug or alcohol dependence and/or abuse. Worsening of depression, emergence of suicidality have been reported. Eszopiclone has rapid onset of action and must be taken immediately before bedtime or after experiencing difficulty sleeping. May impair ability to drive or operate machinery. Hypersensitivity reaction including angioedema involving the tongue, glottis or larynx, and symptoms suggestive of anaphylaxis have been reported. Abrupt discontinuance or rapid dose reduction may cause withdrawal symptoms. Caution in hepatic impairment; elderly/debilitated patients. Safety and efficacy have not been established in children <18 yr. Pregnancy and lactation. Lactation: excretion in milk unknown; use with caution _ Side Effect >10% Headache (13-21%),Unpleasant taste (17-34% in non-elderly) 1-10% Abnormal dreams (elderly),Accidental injury (elderly),Diarrhea,Dizziness,Dry mouth,Dyspepsia,Nervousness,Neuralgia,Pain,Pruritus,Rash (in non-elderly),Somnolence,Unpleasant taste (elderly),UTI <1% Agitation,Alopecia,Angioedema,Asthma,Anorexia,Cystitis,Dysphagia,Fever,Epistaxis,Hypertension,Hostility,Hypercholesterolemia,Hypokalemia Potentially Fatal: Anaphylaxis reactions, angioedema involving the tongue, glottis or larynx. _ Pregnancy Category Note Pregnancy Available pharmacovigilance data with use in pregnant women are insufficient to identify drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes Animal data In animal reproduction studies conducted in pregnant rats and rabbits throughout organogenesis, there was no evidence of teratogenicity; administration to rats throughout pregnancy and lactation resulted in offspring toxicities at all doses tested; lowest dose was approximately 200 times maximum recommended human dose (MRHD) of 3 mg/day based on mg/ m² body surface area Lactation There are no data on prescence in either human or animal milk, effects on breastfed infant, or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or underlying maternal condition _ Interaction Concurrent use of CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir) may decrease metabolism and increase plasma concentrations of Eszopiclone; dosage reduction of Eszopiclone may be needed. Concurrent use with CYP3A4 inducers (e.g. rifampicin) may reduce concentrations of Eszopiclone. May enhance adverse CNS effects when used with alcohol, anticonvulsants, antihistamines, or other psychotropic drugs. Concurrent use with flumazenil may diminish the sedative effect of nonbenzodiazepine hypnotics. _