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Safety Advices
বাংলা
English
UNSAFE
It is unsafe to consume alcohol with Sominex.
CONSULT YOUR DOCTOR
Sominex may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
CONSULT YOUR DOCTOR
Sominex is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.
Baby should be monitored for excessive sleepiness.
UNSAFE
Sominex may cause side effects which could affect your ability to drive.
Sominex may impair alertness and motor coordination, including the risk of morning impairment this risk increases with dose and this may affect your ability to drive.
SAFE IF PRESCRIBED
Sominex is safe to use in patients with kidney disease. No dose adjustment of Sominex is recommended.
CAUTION
Sominex should be used with caution in patients with severe liver disease. Dose adjustment of Sominex may be needed. Please consult your doctor.
Limited information is available on the use of Sominex in these patients. No dose adjustment is recommended in patients with mild to moderate liver disease.
Medicine Overview of Sominex 1mg Tablet
Introduction
Sominex 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. Sominex 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...
... Show moreUses of Sominex
- Insomnia
Side effects of Sominex
Common
- Sleepiness
- Dizziness
- Headache
- Taste change
- Dryness in mouth
- Rash
- Anxiety
- Hallucination
- Respiratory tract infection
- Viral infection
How to use Sominex
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. Sominex is to be taken empty stomach.
How Sominex works
Sominex 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.
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...
... Show moreSide 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...
... Show moreInteraction
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.
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