Zopiclone is a medication used to treat a sleeping problem called insomnia. Zopiclone is a sleeping pill that belongs to a group of drugs called non-benzodiazepine hypnotics. It has a different structure to benzodiazepine sedative hypnotics, such as Halcion (triazolam), but has similar benefits and side effects.
Zopiclone helps to reduce the amount of time it takes you to fall asleep (sleep latency), increase the amount of time you sleep for (sleep duration), and decrease the number of times you wake up at night (nocturnal awakenings). Zopiclone starts to work quickly, taking about an hour to work.
Zopiclone works by binding to a receptor in your brain called the gamma-aminobutyric acid type A (GABAA) receptor and enhancing the action of gamma-aminobutyric acid (GABA), a chemical messenger that has a calming effect.
Zopiclone became available in the 1980s and is approved for use in many parts of the world. However, it is not available in the US where it is a schedule IV controlled substance. The US Food and Drug Administration (FDA) has approved eszopiclone (Lunesta). Eszopiclone is a stereoisomer of zopiclone, which means it is made up of the same parts connected in the same sequences, but its 3D structure is different.
Zopiclone usually comes as a tablet. In some countries, your doctor may be able to order you an oral solution containing this medication if you have trouble swallowing. Branded and generic versions of zopiclone are available.
Zopiclone side effects
Serious side effects of zopiclone include:
Allergic reactions. The signs of an allergic reaction may include:
a rash
swallowing or breathing problems
swelling of your lips, face, throat or tongue Stop taking this medication and see a doctor or go to the emergency room straight away if you develop symptoms of an allergic reaction.
Tell your doctor as soon as possible if you have any of the following side effects, which are rare or of unknown frequency:
Poor memory (amnesia) since starting this medication. This problem is less likely to occur if you have 7-8 hours of uninterrupted sleep after taking this medication.
Seeing or hearing things that are not real (hallucinations)
Falling, especially in the elderly
Thinking things that are not true (delusions)
Feeling low or sad (depressed mood)
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
Including the following common side effects of zopicolne:
A mild bitter or metallic taste in your mouth or a dry mouth
Feeling drowsy or sleepy
Dry mouth
Including the following uncommon side effects of zopiclone:
Feeling sick (nausea) or being sick (vomiting)
Feeling dizzy or sleepy
Headache
Nightmares
Feeling physically or mentally tired
Agitation
Including the following rare side effects of zopiclone:
Feeling confused
Itchy, lumpy rash (urticaria)
Feeling irritable or aggressive
Reduced sex drive
Difficulty breathing or being short of breath
Including the following side effects of unknown frequency of zopiclone:
Feeling restless or angry
Feeling light headed or having problems with your coordination
Double vision
Moving unsteadily or staggering
Muscular weakness
Indigestion
Becoming dependent on this medication
Slower breathing (respiratory depression)
Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (paraesthesia)
Mental problems such as poor memory
Difficulty paying attention
Disrupted normal speech
Zopiclone may cause sleepwalking or other unusual behavior (such as driving, eating, making a phone call, or having sex etc.) while not being fully awake.
These are not all of the possible side effects of zopiclone.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Before taking Zopiclone
Zopiclone is not recommended during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Taking zopiclone during pregnancy may affect your baby.
Some studies have shown that there may be an increased risk of cleft lip and palate (sometimes called “harelip”) in the newborn baby.
Reduced fetal movement and fetal heart rate variability may occur after taking zopiclone during the second or third trimester of pregnancy.
If zopiclone is taken at the end of pregnancy or during labour, your baby may show muscle weakness, a drop in body temperature, difficulty feeding and breathing problems (respiratory depression).
If this medicine is taken regularly in late pregnancy, your baby may develop physical dependence and may be at risk of developing withdrawal symptoms such as agitation or shaking. In this case the newborn should be closely monitored during the postnatal period.
Do not take zopiclone if you are breastfeeding or plan to breastfeed. Small amounts of this medication may pass into breast milk. If you are breastfeeding or plan to breastfeed, talk to your doctor or pharmacist before taking any medicine.
How to use Zopiclone
Adults. The recommended dose in adults is one zopiclone 7.5mg tablet just before bedtime.
Elderly - aged over 65 years old. The usual starting dose in elderly patients is one zopiclone low-strength (LS) tablet (3.75 mg) or half a full-strength (7.5 mg) tablet just before bedtime. Your doctor may decide to increase your dose to one 7.5 mg tablet if needed.
People with liver or kidney problems. The recommended dose for people with liver and kidney problems is one zopiclone low-strength (LS) tablet (3.75 mg) or half a full-strength (7.5 mg) tablet just before bedtime.
Children and adolescents. Zopiclone should not be used in children and adolescents less than 18 years. The safety and efficacy of this medication children and adolescents aged less than 18 years have not been established.
See the full prescribing information for further zopiclone dosing information.
Warnings
Zopiclone may cause serious side effects.
Use of this medication may lead to the development of abuse and/or physical and psychological dependence. The risk of dependence increases with dose and duration of treatment and is greater when this medication is used for more than 4 weeks, and in patients with a history of mental disorders and/or alcohol, illicit substance or drug abuse.
Drowsiness, difficulties breathing, coma and death may occur if zopiclone is taken together with opioids. Zopiclone and opioids should only be used at the same time, when other treatment options are inadequate. Please tell your doctor about all opioid medicines you are taking and follow your doctor’s dosage recommendations closely.
Some studies have shown an increased risk of suicidal ideation, suicide attempt and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is caused by the medicine or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for further medical advice.
Before taking zopiclone, it is important to make sure that you can have at least 7 to 8 hours of uninterrupted sleep to help reduce the risk of some side effects.
Zopiclone may cause sleepwalking or other unusual behavior (such as driving, eating, making a phone call, or having sex etc.) while not being fully awake. The next morning, you may not remember that you did anything during the night. These activities may occur whether or not you drink alcohol or take other medicines that make you drowsy with zopiclone. If you experience any of the above, stop the treatment with this medication immediately and contact your doctor or healthcare provider.
What other drugs will affect Zopiclone
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you are taking any of the medicines listed below.
Zopiclone may increase the effect of the following medicines:
Medicines for mental problems (antipsychotics)
Medicines for depression
Medicines for epilepsy (anticonvulsants)
Medicines used in surgery (anaesthetics)
Medicines to calm or reduce anxiety or for sleep problems (hypnotics)
Medicines for hay fever, rashes or other allergies that can make you sleepy (sedative antihistamines) such as chlorphenamine or promethazine
Some medicines for moderate to severe pain (narcotic analgesics) such as codeine, methadone, morphine, oxycodone, pethidine or tramadol
The following medicines can increase the chances of you getting side effects when taken with zopiclone. To make this less likely, your doctor may decide to lower your dose of zopiclone:
Some antibiotics such as clarithromycin or erythromycin
Some medicines for fungal infections such as ketaconazole and itraconazole
Ritonavir (a protease inhibitor) - for HIV infections
Concomitant use of zopiclone and opioids increases the risk of drowsiness, difficulties breathing, coma and death. Follow your doctor’s dosage recommendations closely.
The following medicines can make zopiclone less effective:
Some medicines for epilepsy such as Carbamazepine, phenobarbital or phenytoin
Rifampicin (an antibiotic) - for infections
St John’s Wort (a herbal medicine) - for mood swings and depression
This medication can change the levels of liver enzymes shown up in blood tests. This can mean that your liver is not working properly. If you are going to have a blood test, it is important to tell your doctor that you are taking zopiclone.
Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
