Intas Pharmaceuticals Ltd
Classified as a chemically-novel hypnotic agent, zopiclone (Zimovane) is a generally safe-to-use sleeping tablet that should be prescribed only for short-term use. It is a medication that’s used to treat insomnia.
It works by affecting the manner in which signals are sent to your brain, making you feel drowsy. The hypnotic medication reduces the duration it takes for you to fall asleep, and it extends the time you spend sleeping.
Poor sleep or insomnia is common among many people, but the condition doesn’t last a long time. Zopiclone is used for the treatment of adult sleep problems that include:
- Waking in the middle of the night,
- Waking up too early in the morning,
- Difficulty falling asleep, and/or
- Upsetting or severe sleep problems that are caused by mental health problems or your mood.
While considered to be the last resort, ‘sleeping pills’ that include zopiclone are occasionally prescribed for a short duration to help if you’re suffering from a bad bout of insomnia.
While zopiclone may at times be used for the long-term, the medication is not meant to treat depression or to be used every day for long durations. If you’re unsure about how to use the product properly, consult with your physician.
Ongoing deprivation of sleep can negatively affect you. You may experience mood changes, lack of motivation, lack of energy, and you may also experience irritability. Daytime drowsiness can also affect your work and social life, as your concentration ability may be reduced.
Zopiclone allows the body to get that much-needed rest. When taken in the right dosage, the medication can result in zero to few effects experienced because of sleep deprivation.
Available only through prescription, zopiclone comes in tablet form (3.75mg and 7.5mg). The medication can also come in liquid form for individuals who have problems in swallowing tablets. However, your doctor should be the one to order this medicine in such form.
The 3.75m biconvex film-coated, round zopiclone tablets have diameters ranging from 5.95mm to 6.25mm. The tablets are colored white to off-white.
The 7.5mm oval, white to off-white tablets have lengths from 9.95mm to 10.25mm. Widths range from 4.95mm to 5.25mm. The biconvex film-coated zopiclone tablets have break lines on one side.
The tablets are packed in aluminum blisters (clear white PVC) that pack 7, 10, 14, 28, to 30 tablets.
Ingredients and Composition
Zopiclone (Zimovane) has a molecular weight of 388.8 and a molecular formula of C₁₇H₁₇CIN₆O₃. The hypnotic medication is a lightly-yellowish or white powder and is water-insoluble. It’s sparingly soluble in acetone, freely soluble in methyl chloride, and practically insoluble in alcohol.
Zopiclone dissolves in mineral acids that are diluted. The medication – with decomposition – melts at around 350°F (177°C).
The medication’s active substance is zopiclone. The rest of the ingredients include calcium hydrogen phosphate dihydrate, lactose monohydrate, maize starch, magnesium stearate, starch pregelatinized, titanium dioxide, hypromellose, macrogol 400, and purified water.
Zopiclone also has lactose, which is a sugar. If you’re sugar-intolerant, consult with your doctor first before taking zopiclone.
- Doctors usually prescribe zopiclone for durations of 2-4 weeks. Why? Your body quickly adjusts to the medication. After such time, zopiclone may not be as effective, and your body could become dependent on it.
- It takes about 1 hour for zopiclone to work.
- While you’re taking zopiclone, don’t drink alcohol. A combination of both substances may let you fall into a deeper sleep, which you may find difficult to wake up from.
- Some of the normal side effects of taking zopiclone include daytime sleepiness, dry mouth, and a metallic taste in your mouth, among others.
Before Taking Zopiclone
Before you consider taking zopiclone, make sure to check with your doctor if the medication is safe for you. Discuss with your doctor if:
- You’re suffering from kidney issues. You may be prescribed lower zopiclone (Zimovane) dose.
- You have or had liver issues. You may be prescribed a lower dose.
- You’re suffering from moderate breathing problems. The doctor will decide if you can take zopiclone.
- You have been diagnosed with a personality disorder.
- You have a history of drug or alcohol abuse.
- You have just taken zopiclone or similar medication for over 4 weeks.
- You feel you won’t be able to stop taking zopiclone.
Before you take Zimovane, make sure that you sleep uninterrupted for 7-8 hours to help reduce the risk of experiencing side effects.
The doctor will start prescribing you the lowest effective dose, and the treatment period should be short and not exceed 4 weeks, including the tapering-off period.
Don’t deviate from the doctor’s prescription. If you’re not sure when it comes to taking Zimovane, check with the pharmacist or your doctor.
- Take the medication orally.
- Take the tablet together with a glass of water.
- Do not chew or crush the tablets.
- Take zopiclone just before you sleep. Take in one dose and do not take the medication again on the same night.
- Treatment duration is usually from 2 to 3 weeks.
Adults. The normal dose is taking a 7.5mm zopiclone tablet the moment before bedtime.
Children and Adolescents. Children and teenagers below the age of 18 should not take zopiclone. The efficacy and safety of the medication in such individuals have not yet been determined.
Patients with Respiratory, Kidney, or Liver Problems. For these individuals, the normal starting dose is one 3.75mm zopiclone tablet before bedtime.
Elderly. The standard initial dose is 3.75mg before sleeping. If needed, the doctor may recommend increasing the dose to one 7.5mm zopiclone tablet.
- If you’re having a blood test, inform your doctor or the laboratory attendant that you’re taking zopiclone.
- Zopiclone may alter liver enzymes’ levels that can show up in blood tests. This may mean your liver is not functioning properly.
Overdosing on Zopiclone
Get emergency medical treatment or tell your doctor if you’re taking more than the recommended zopiclone dose. Make sure to bring the medicine pack with you, so your doctor or the emergency room’s attending physician will know the dose you have taken. It can be dangerous if you overdose on zopiclone – on purpose or by accident.
Some effects of overdose may include:
- Hypotonia (flopping muscles);
- Feeling confused, drowsy, sleeping deeply with the possibility of falling into a coma;
- Feeling faint, light-headed, or dizzy (effects of low-blood pressure);
- Difficulty breathing (respiratory depression) or shallow breathing; and/or
- Losing balance (ataxia) or falling over.
Forgetting a Dose
Only take zopiclone (Zimovane) during bedtime. If you missed your dose, don’t take it at another time, or you may feel dizzy, confused, and drowsy during the day. To make up for the missed dose, don’t take a double dose the following night.
When You Stop Taking Zopiclone
Until your doctor says so, you can continue to keep taking zopiclone. Stopping medication involved consultation with your doctor, and don’t abruptly stop taking the medication. Your dose may be reduced before the doctor tells you to stop taking the medication altogether.
If you suddenly stop treatment, you may experience withdrawal symptoms and your sleep issues may return. See the doctor immediately if you experience the following symptoms:
- Feeling shaky, anxious, agitated, confused, irritable, or having panic attacks;
- A lower awareness level and problems with concentrating or focusing;
- Uneven heartbeat (palpitations) or fast heartbeat;
- Being more sensitive to touch, noise, and light than usual;
- Nightmares, hearing or seeing things that aren’t there (hallucinations);
- Relaxed hold on reality;
- Stomach issues;
- Aching muscles; and/or
- Tingling and numbness in your feet and hands.
Seizures (fits) may also occur in some cases.
Potential Side Effects
Zopiclone (Zimovane), like all medications, can lead to side effects. Not everyone gets them though. Stop taking the medication and go to a hospital or see your doctor if you experience any allergic reactions like breathing or swallowing problems, a rash, or swelling of your face, lips, tongue, or throat.
Also inform your doctor if you experience rare (1 to 10 users out of 10,000) side effects like:
- You’re having poor memory or amnesia since taking the medication. You may not experience any problem if you have 7 to 8 hours of continuous sleep after taking zopiclone.
- Falling, particularly in the elderly.
- Hallucinations or hearing or seeing things that aren’t there.
Other possible side effects, although they have not yet been established, include:
- Depressed mood (feeling sad or low).
- Delusions or thinking things that are untrue.
Also, inform your doctor or the pharmacist if any effects become worse or last longer than several days. These side effects include:
Common (affecting 1 to 10 users out of 100)
- Feeling sleepy or drowsy,
- Dry mouth, and/or
- A metallic or mild bitter taste in your mouth.
Uncommon (affecting 1 to 10 users out of 1,000)
- Feeling sleepy or dizzy,
- Being sick (vomiting) or feeling sick (nausea),
- Agitation, and/or
- Feeling mentally or physically tired.
Rare (affecting 1 to 10 users out of 10,000)
- Lumpy or itchy rash (urticarial),
- Feeling confused,
- Reduced sex drive,
- Feeling aggressive or irritable, and/or
- Being short of breath or difficulty breathing.
Unknown (frequency has not yet been established)
- Having coordination problems or feeling light-headed;
- Feeling angry or restless;
- Double vision;
- Muscular weakness;
- Staggering or moving unsteadily;
- Becoming dependent on Zimovane;
- Respiratory depression (slower breathing);
- Mental issues like poor memory;
- Disrupted normal sleep;
- Difficulty in paying attention; and/or
- Paresthesia or unusual skin sensations like tingling, numbness, burning, creeping, or prickling on the skin.
Strange Behavior Like Sleep-Driving
There are reports of individuals doing things asleep that they don’t remember after taking sleep medication or when waking up. Such activities include sleep-walking and sleep-driving.
Alcohol and certain anti-depression or anti-anxiety meds can increase the likelihood of sleep-driving or sleep-walking to occur.
Interactions with Other Medications
Before taking zopiclone, inform the doctor of other meds you’re taking. This can also include any supplements. Why? Zopiclone can affect other medicines’ efficacy. Moreover, certain meds can affect how zopiclone works.
Some of these medicines include:
- Depression medicines.
- Anti-psychotics/medicines for mental issues.
- Anti-convulsants/epilepsy medicines.
- Anesthetics/surgery medications.
- Other hypnotics. Medicines for sleep problems or to reduce or calm anxiety.
- Narcotic analgesics. These medicines (methadone, codeine, oxycodone, morphine, tramadol, or pethidine) are used to manage medium to severe pain.
- Sedative antihistamines like promethazine or chlorphenamine. These medicines for rashes or hay fever can make you drowsy.
Certain medications can increase the likelihood of experiencing side effects when you take such medicines with zopiclone. The doctor may lower the dosage of the following medications:
- Antibiotics like erythromycin or clarithromycin.
- A protease inhibitor (ritonavir) for HIV infections.
- Fungal infection medicines like itraconazole or ketoconazole.
Certain medicines can diminish zopiclone’s efficacy. These medications include:
- The antibiotic rifampicin for infections.
- An herbal medicine – St. John’s Wort – for depression and mood swings.
- Certain epilepsy medications like phenytoin, phenobarbital, or carbamazepine.
Zopiclone with Drink, Alcohol, and Food
When you’re taking zopiclone (Zimovane), don’t drink alcohol. The substance can increase zopiclone’s effects and make you sleep deeper. As such, you may have difficulty waking up or you may not breathe properly.
Pregnancy and Zopiclone
If you’re pregnant, think you’re pregnant, or you might become pregnant, consult with your doctor before taking zopiclone.
Don’t take the medication during labor or during your last trimester as the drug may harm the baby.
If you’re taking Zopiclone, do not breastfeed, as small amounts of the medication can seep into the mother’s milk. If you’re planning to breastfeed or are breastfeeding, talk to the doctor before you take zopiclone.
Using Machinery and Driving
Zopiclone can slow down brain function (depression of the central nervous system). The risk of developing psychomotor development rises if:
- You take more than the recommended zopiclone dose.
- You take the medication within 12 hours of doing activities that require mental alertness.
- You take zopiclone while taking another similar drug, or a drug that increases zopiclone levels in your blood.
Do not do hazardous activities that require absolute mental attention like operating machinery or driving a vehicle after taking zopiclone during the 12-hour period after you take the medication.
Keep zopiclone (Zimovane) in a safe area where children can’t see or access it. Don’t use the medicine after the stated expiry date, which refers to the month’s last day.
Keep the zopiclone blister pack in the carton to ensure it’s protected from moisture and light. Also, keep the medicine at a temperature below 30°C (86°F).
Don’t dispose of the medicines through household waste or wastewater. Ask the pharmacist on the proper disposal of medicines that are no longer used. Such measures can help in environmental protection.