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{{drugbox
{{DrugProjectFormSinglePage
| IUPAC_name = [8-(5-chloropyridin-2-yl)- 7-oxo-2,5,8-triazabicyclo [4.3.0]nona-1,3,5-trien-9-yl] 4- methylpiperazine-1-carboxylate
|authorTag=<!--Overview-->
| image = Zopiclone.png
|aOrAn=a
| width = 163
|hasBlackBoxWarning=Yes
| CAS_number = 43200-80-2
|adverseReactions=<!--Black Box Warning-->
| ATC_prefix = N05
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
| ATC_suffix = CF01
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
| ATC_supplemental =  
 
| PubChem = 5735
* Content
| DrugBank = APRD00356
 
| C=17 | H=17 | Cl=1 | N=6 | O=3
<!--Adult Indications and Dosage-->
| molecular_weight = 388.808 g/mol
 
| bioavailability = 52-59% bound to plasma protein
<!--FDA-Labeled Indications and Dosage (Adult)-->
| protein_bound =  
|fdaLIADAdult======Condition1=====
| metabolism = Various cytochrome P450 liver enzymes
 
| elimination_half-life = ~6 hours <br> ~9 hours for over 65
* Dosing Information
| pregnancy_US = C
 
| legal_US = Schedule IV
:* Dosage
| legal_UK = POM
 
| routes_of_administration = Oral tablets 7.5 mg
=====Condition2=====
| excretion = Urine
 
}}
* Dosing Information
{{SI}}
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
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<!--Guideline-Supported Use (Adult)-->
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* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
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There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
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* Dosing Information
 
:* Dosage
 
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There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
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<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
 
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There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
 
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There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
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|warnings=* Description
 
====Precautions====
 
* Description
 
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|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 
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|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
|administration=* Oral
 
* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


* Description


==Overview==
<!--IV Compatibility-->
'''Zopiclone''' (pronounced {{IPA2|ˈzopɪˌkləʊn}}) sold as '''Imovane''' and '''Zimovane''' in Europe, and as the [[eszopiclone]] analogue '''Lunesta''' in North America, is a novel [[hypnotic]] agent used in the treatment of [[insomnia]]. Zopiclone is also available world wide under various [[#Availability|other trade names]]. It was first developed by [[Sepracor]] and introduced in [[1988]] by [[Rhône-Poulenc]] S.A., now part of [[Sanofi-Aventis]], the main worldwide manufacturer of the drug. Zopiclone is a controlled substance in the [[United States]], [[Canada]] and some [[Europe]]an countries and may be illegal to possess without a prescription.
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.


While it acts on the [[BZ1|BZ¹]] receptor and is a short-acting hypnotic agent, it is not a [[benzodiazepine]] (with which it shares a number of characteristics and effects), but a [[cyclopyrrolone]] derivative, belonging to a novel chemical class which is structurally unrelated to existing hypnotics.
<!--Overdosage-->
|overdose====Acute Overdose===


On [[April 4]], [[2005]], the United States [[Drug Enforcement Administration|DEA]] listed zopiclone under [[Controlled Substances Act|Schedule IV]], due to some evidence that the drug has [[Drug addiction|addictive]] properties similar to [[benzodiazepine]]s.
====Signs and Symptoms====


Zopiclone, as traditionally sold worldwide, is a [[racemic]] mixture of two [[stereoisomer]]s, only one of which is active. In 2005, the pharmaceutical company [[Sepracor]], of [[Marlborough, Massachusetts]], began marketing the active stereoisomer [[eszopiclone]] under the name '''Lunesta''' in the [[United States]]. This had the consequence of placing what is a generic drug in most of the world under patent control in the United States, although in that country, it is expected to be available in generic form by the year 2010. It is already available off-patent in a number of European countries as well as [[Brazil]]. The eszopiclone/zopiclone difference is in the dosage&mdash;the strongest [[eszopiclone]] derivative dosage contains 3mg of the therapeutic stereoisomer, whereas, the highest zopiclone dosage (7.5mg) contains 3.75mg of the active stereoisomer. The two agents have not been studied via head-to-head clinical trials to determine if any clinical differences exist (e.g., efficacy, side-effects, developing dependence on the drug, and safety, etc.).
* Description


Zopiclone is known colloquially as a "Z drug", Other Z drugs include [[zaleplon]] (Sonata) and [[zolpidem]] (Ambien and AmbienCR) and were thought in initial studies to be less addictive and less habit forming than benzodiazepines. This appraisal has shifted somewhat in the last few years, as cases of addiction and habituation have been presented. It is recommended that zopiclone is taken on a "when required" basis, and daily or continuous use of the drug is not usually advised.
====Management====


==Adverse reactions==
* Description
The side-effect most commonly seen in clinical trials is taste alteration or [[dysgeusia]] (bitter, metallic taste, which is usually fleeting in most users but can persist until the drug's half-life has expired). [[Heart palpitation|Palpitations]] may occur in the daytime after withdrawal from the drug after prolonged periods of use (>4 weeks).


===More common reactions:===
===Chronic Overdose===
Gastrointestinal: bitter metallic taste, [[dry mouth]].
Nervous system: drowsiness, [[headache]]s, and [[Fatigue (physical)|fatigue]]. Unexpected mood changes have been noted, which if experienced should lead to the drug being withdrawn from the patient.


===Less common reactions:===
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
* '''Gastrointestinal''': [[heartburn]], [[constipation]], [[diarrhoea]], [[nausea]], coated tongue, [[bad breath]], [[anorexia (symptom)|anorexia]] or increased [[appetite]], [[vomiting]], [[epigastric]] pains, [[dyspepsia]], [[dehydration]], [[parageusia]].
* '''Cardiovascular''': [[palpitation]]s in [[Senior citizen|elderly]] patients.
* '''Skin''': [[urticaria]], [[Parathesia|tingling]] in the arms and legs.
* '''Miscellaneous''': blurred vision, frequent [[micturition]], mild to moderate increases in [[blood plasma|serum]] [[transaminase]]s and/or [[alkaline]] [[phosphatase]] have been reported very rarely.
* '''Reproductive''': [[impotence]], [[ejaculation]] failure, [[anorgasmia]] in both women and men.
* '''Nervous system''': [[agitation]], [[anxiety]], loss of memory including [[retrograde amnesia|retrograde]] and [[anterograde amnesia]], [[confusion]], [[dizziness]], [[weakness]], [[somnolence]], [[asthenia]], moderate to severe [[Euphoria (emotion)|euphoria]] and/or [[dysphoria]], feeling of drunkenness, [[depression (mood)|depression]], coordination abnormality, [[hypotonia]], speech disorder, [[hallucination]]s of various strengths, usually auditory and visual, behavioural disorders, [[aggression]], [[tremor]], rebound insomnia, [[nightmare]]s, [[hypomania]].


==Pharmacokinetics==
<!--Pharmacology-->
Zopiclone is a cyclopyrrolone hypnotic agent. It possesses a chiral centre and is commercially available as a [[racemic]] mixture. Methods involving high performance [[liquid chromatography]] (HPLC), [[gas chromatography]], capillary electrophoresis (CE) and high performance thin layer chromatography have been developed for the quantification of zopiclone and its 2 main metabolites in biological samples. For the chiral determination of the enantiomers of zopiclone and its metabolites, HPLC and CE methods are available. After oral administration, zopiclone is rapidly absorbed, with a bioavailability of approximately 80%. The plasma protein binding of zopiclone has been reported to be between 45 and 80%. Zopiclone is rapidly and widely distributed to body tissues including the brain, and is excreted in urine, saliva and breast milk. Zopiclone is partly metabolised in the liver to form an inactive N-demethylated derivative and an active N-oxide metabolite. In addition, approximately 50% of the administered dose is decarboxylated and excreted via the lungs. Less than 7% of the administered dose is [[renally]] excreted as unchanged zopiclone. In urine, the N-demethyl and N-oxide metabolites account for 30% of the initial dose. The terminal elimination half-life (t1/2z) of zopiclone ranges from 3.5 to 6.5 hours. The [[pharmacokinetics]] of zopiclone in humans are stereoselective. After oral administration of the racemic mixture, Cmax (time to maximum plasma concentration), AUC (area under the plasma time-concentration curve) and t1/2z values are higher for the dextrorotatory enantiomer owing to the slower total clearance and smaller volume of distribution (corrected by the bioavailability), compared with the levorotatory enantiomer. In urine, the concentrations of the dextrorotatory enantiomers of the N-demethyl and N-oxide metabolites are higher than those of the respective antipodes. The pharmacokinetics of zopiclone are altered by aging and are influenced by renal and hepatic functions. Drug interactions have been observed with [[erythromycin]], [[trimipramine]] and [[carbamazepine]].


==Pharmacology==
<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*


The mechanism of action of zopiclone is similar to [[benzodiazepines]], with similar effects on [[locomotor activity]] and on [[dopamine]] and [[serotonin]] turnover.<ref>{{cite journal | author = Liu HJ | coauthors = Sato K, Shih HC, Shibuya T, Kawamoto H, Kitagawa H. | year = 1985 | month = Mar | title = Pharmacologic studies of the central action of zopiclone: effects on locomotor activity and brain monoamines in rats. | journal = Int J Clin Pharmacol Ther Toxicol. | volume = 23 | issue = 3 | pages = 121-8 | pmid = 2581904 }}</ref><ref>{{cite journal | author = Sato K | coauthors = Hong YL, Yang MS, Shibuya T, Kawamoto H, Kitagawa H. | year = 1985 | month = Apr | title = Pharmacologic studies of central actions of zopiclone: influence on brain monoamines in rats under stressful condition. | journal = Int J Clin Pharmacol Ther Toxicol. | volume = 23 | issue = 4 | pages = 204-10 | pmid = 2860074 }}</ref>
<!--Structure-->
A [[meta-analysis]] of randomised controlled [[clinical trials]] which compared benzodiazepines to Zopiclone or other Z Drugs such as [[zolpidem]], [[zaleplon]] has found that there are few clear and consistent differences between Zopiclone and the [[benzodiazepines]] in terms of sleep onset latency, total sleep duration, number of awakenings, quality of sleep, adverse events, tolerance, rebound insomnia and daytime alertness.<ref>{{cite journal | last = Dündar | first = Y | coauthors = Dodd S, Strobl J, Boland A, Dickson R, Walley T. | year = 2004 | month = Jul | title = Comparative efficacy of newer hypnotic drugs for the short-term management of insomnia: a systematic review and meta-analysis. | journal = Hum Psychopharmacol. | volume = 19 | issue = 5 | pages = 305-22 | pmid = 15252823 }}</ref>
|structure=*
Zopiclone is in the [[cyclopyrrolone]] family of drugs. Other cyclopyrrolone drugs include [[suriclone]]. Zopiclone although molecularly different from benzodiazepines, shares an almost identical pharmacological profile as benzodiazepines including anxiolytic properties. Its mechanism of action is modulating benzodiazepine receptors.<ref>{{cite journal | author = Blanchard JC | coauthors = Julou L. | year = 1983 | month = Mar | title = Suriclone: a new cyclopyrrolone derivative recognizing receptors labeled by benzodiazepines in rat hippocampus and cerebellum. | journal = J Neurochem. | volume = 40 | issue = 3 | pages = 601-7 | pmid = 6298365 }}</ref> In addition to zopiclone's benzodiazepine pharmacological properties it also has some [[barbiturate]] like properties.<ref>{{cite journal | author = Julou L | coauthors = Bardone MC, Blanchard JC, Garret C, Stutzmann JM. | year = 1983 | month = | title = Pharmacological studies on zopiclone. | journal = Pharmacology. | volume = 27 | issue = 2 | pages = 46-58 | pmid = 6142468 }}</ref><ref>{{cite journal | author = Blanchard JC | coauthors = Boireau A, Julou L. | year = 1983 | month = | title = Brain receptors and zopiclone. | journal = Pharmacology. | volume = 27 | issue = 2 | pages = 59-69 | pmid = 6322210 }}</ref>


In [[EEG]] studies, zopiclone significantly increases the energy of the beta frequency band and shows characteristics of high-voltage slow waves, desynchronization of hippocampal theta waves and an increase in the energy of the delta frequency band. Zopiclone increases both stage 2 and slow wave sleep (SWS), while [[zolpidem]], an omega1-selective compound, increases only SWS and causes no effect on stage 2 sleep. Zopiclone is less selective to the omega1 site and has higher affinity to the omega2 site than [[zaleplon]]. Zopiclone is therefore very similar pharmacologically to benzodiazepines.<ref>{{cite journal | author = Noguchi H | coauthors = Kitazumi K, Mori M, Shiba T. | year = 2004 | month = Mar | title = Electroencephalographic properties of zaleplon, a non-benzodiazepine sedative/hypnotic, in rats. | journal = J Pharmacol Sci. | volume = 94 | issue = 3  pages = 246-51 | pmid = 15037809 | url = http://www.jstage.jst.go.jp/article/jphs/94/3/246/_pdf | format = pdf }}</ref>
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


==Dependence and withdrawal==
<!--Pharmacodynamics-->
Zopiclone was introduced and initially promoted as having less dependence and withdrawal than traditional [[benzodiazepine]] drugs. However zopiclone may have an even greater addictive potential than benzodiazepines.<ref>{{cite journal | author = Bramness JG | coauthors = Olsen H. | year = 1998 | title = [Adverse effects of zopiclone] | journal = Tidsskrift for den Norske laegeforening. | volume = 118 | issue = 13 | pages = 2029-32 | pmid = 9656789 }}</ref> Benzodiazepines act indiscriminately at α¹ α² α³ and α<sup><small>5</small></sup> [[Gamma aminobutyric acid|GABAa]] containing receptors. Zopiclone has high affinity for the alpha¹ subunit GABAa receptor and a low to intermediate action on α² and α³. receptors.<ref>[http://jpet.aspetjournals.org/cgi/content/full/302/2/612 Molecular actions of (S)-desmethylzopiclone (SEP-174559), an anxiolytic metabolite of zopiclone]</ref> The alpha1 alpha2 and alpha3 GABAa receptors make up over 90% of all GABAa receptors in humans. The differences in receptor affinity and binding of zopiclone compared with benzodiazepines have led some to claims of a lower dependency risk with zopiclone.
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.


Publications in the ''[[British Medical Journal]]'' have cast some doubt on the claim that zopiclone has a low dependence potential. Physical dependence and recreational abuse and withdrawal syndromes similar to those seen in [[benzodiazepine withdrawal]] has been described. Withdrawal symptoms included [[anxiety]], [[tachycardia]], [[tremor]], sweats, flushes, [[palpitations]], [[derealisation]], and further insomnia.<ref>[http://www.bmj.com/cgi/content/full/316/7125/117 Physical dependence on zopiclone: case reports]</ref>
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.


High dose misuse of zopiclone and increasing popularity amongst drug abusers has also been described with zopiclone<ref>[http://www.bmj.com/cgi/content/full/317/7151/146 Prescribing this drug to addicts may give rise to iatrogenic drug misuse]</ref>
<!--Nonclinical Toxicology-->
Due to the risk of tolerance and physical dependence zopiclone is only recommended for the short term (2&ndash;4 weeks) relief of insomnia, or alternatively, long term infrequent use. Long-term zopiclone users who have become physically dependent are usually recommended to cross over to an equivalent dose of [[diazepam]] (Valium®) which has a longer half life and reduce their dosage over a period of months to avoid severe or unpleasant withdrawal symptoms. According to the [[World Health Organisation]] Zopiclone although molecularly is not a [[benzodiazepine]] binds with high affinity to [[benzodiazepine]] receptors and stated that Zopiclone is cross tolerant with [[benzodiazepines]] and one can substitute one for the other. In the review of Zopiclone by the [[World Health Organisation]] they found that the appearance of [[withdrawal symptoms]] usually occurred either when the drug was misused in excessive doses or when use of zopiclone was prolonged. The [[withdrawal symptoms]] from Zopiclone reported included [[anxiety]], [[tachycardia]], [[tremor]], [[sweating]], rebound [[insomnia]], [[derealisation]], [[convulsions]], [[palpitations]] and flushes.<ref>[http://www.who.int/medicines/areas/quality_safety/4.6ZopicloneCritReview.pdf World Health Organisation - Assessment of Zopiclone]</ref>
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.


The risk of dependency on zopiclone when used for less than 4 weeks or used occasionally is very low.
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.


Alcohol has cross tolerance with GABAa receptor positive modulators such as the [[benzodiazepines]] and the [[nonbenzodiazepine]] drugs. For this reason alcoholics or recovering alcoholics may be at increased risk of [[physical dependency]] on zopiclone. Also, alcoholics and drug abusers may be at increased risk of abusing and or becoming psychologically dependent on zopiclone. Zopiclone should be avoided in those with a history of [[Alcoholism]], [[drug misuse]] (illicit or prescription misuse), or in those with history of [[physical dependency]] or [[psychological dependency]] on sedative-hypnotic drugs.
<!--How Supplied-->
|howSupplied=*


==Special precautions==
<!--Patient Counseling Information-->
Zopiclone induces impairment of motor function.<ref>{{cite journal |author=Yasui M |coauthors=Kato A, Kanemasa T, Murata S, Nishitomi K, Koike K, Tai N, Shinohara S, Tokomura M, Horiuchi M, Abe K. |title=[Pharmacological profiles of benzodiazepinergic hypnotics and correlations with receptor subtypes] |Nihon Shinkei Seishin Yakurigaku Zasshi. |volume=25 |issue=3 |pages=143-51 |month=Jun |year=2005 |pmid=16045197 }}</ref> Driving or operating machinery should be avoided after taking zopiclone.
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


Zopiclone increases sway in older people. Falls are a significant cause of death in older people.
<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


==Abuse==
<!--Brand Names-->
Zopiclone and other sedative hypnotic drugs are detected frequently in cases of people suspected of driving under the influence of drugs. Other drugs including the [[benzodiazepines]] and [[zolpidem]] are also found in high numbers of suspected drugged drivers. Many drivers have blood levels far exceeding the therapeutic dose range suggesting a high degree of abuse potential for [[benzodiazepines]], [[zolpidem]] and zopiclone.<ref>{{cite journal | author = Jones AW | coauthors = Holmgren A, Kugelberg FC. | year = 2007 | month = Apr | title = Concentrations of scheduled prescription drugs in blood of impaired drivers: considerations for interpreting the results. | volume = 29 | issue = 2 | pages = 248-60 | pmid = 17417081 | journal = Ther Drug Monit.}}</ref>
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>


Zopiclone has cross tolerance with barbiturates and is able to suppress barbiturate withdrawal signs. Zopiclone is frequently self administered intravenously in studies on monkeys suggesting a high risk of abuse potential.<ref>{{cite journal | author = Yanagita T. | coauthors = | year = 1982 | month = | title = Dependence potential of zopiclone studied in monkeys. | journal = International pharmacopsychiatry. | volume = 17 | issue = 2 | pages = 216-27 | pmid = 6892368 }}</ref>
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>


==Overdose==
<!--Drug Shortage Status-->
Overdose of zopiclone may present with excessive sedation, depressed respiratory function which may progress to coma and possibly death. Zopiclone combined with alcohol, opiates or other [[CNS]] depressants may be even more likely to lead to fatal overdoses. Zopiclone overdosage can be treated with the benzodiazepine receptor antagonist [[flumazenil]] which displaces zopiclone from its binding site the benzodiazepine receptor and therefore rapidly reverses the effects of zopiclone.<ref>{{cite journal | last = Cienki | first = JJ | coauthors = Burkhart KK, Donovan JW. | year = 2005 | month = | title = Zopiclone overdose responsive to flumazenil. | journal = Clin Toxicol (Phila). | volume = 43 | issue = 5 | pages = 385-6 | pmid = 16235515 }}</ref>
|drugShortage=
}}
{{PillImage
|fileName=No image.jpg
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
}}
<!--Pill Image-->


Death certificates show that fatal zopiclone overdoses are on the rise.<ref>{{cite journal | last = Carlsten | first = A | coauthors = Waern M, Holmgren P, Allebeck P. | year = 2003 | month = | title = The role of benzodiazepines in elderly suicides. | journal = Scand J Public Health. | volume = 31 | issue = 3 | pages = 224-8 | pmid = 12850977 }}</ref>


==Availability==


Zopiclone is also sold under a wide variety of other brand names world wide including:
<!--Label Display Image-->


*'''Insomnium''' - Argentina
*'''Sedolox''' and '''Somnal''' - Austria
*'''Rhovane''' - Canada
*'''Alpaz''', '''Losopil''', '''Nuctane''', '''Zetix''', '''Zometic''' and '''Zonix''' - Chile
*'''Imovane''', '''Imoclone''' and '''Imozop''' - Denmark
*'''Zopinox''', '''Imovane''' - Finland
*'''Optidorm''', '''Ximovan''', '''Zodurat''', '''Zop''', '''Zopi-Puren''', '''Zopicalm''' and '''Zopiclodura''' - Germany
*'''Somnosan''' - Germany, Portugal
*'''Amvey''', '''Eurovan''', '''Zolief''' and '''Zomni''' - Hong Kong
*'''Zopicon''' - India
*'''Zileze''', '''Zimoclone''', '''Zopitan''' and '''Zorclone''' - Republic of Ireland
*'''Zimovane''' - Republic of Ireland, United Kingdom
*'''Nocturno''' - Israel
*'''Imovane (Имован)''' - Argentina, Australia, Belgium, Brazil, Canada, Chile, Czech Republic, Denmark, Finland, France, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Malaysia, Mexico, Netherlands, Norway, New Zealand, Russia, South Africa, Singapore, Sweden, Switzerland, Turkey, Venezuela
*'''Relaxon (Релаксон)''' and '''Somnol (Сомнол)''' - Russia
*'''Alchera''', '''Z-Dorm''', '''Zopimed''' and '''Zopivane''' - South Africa
*'''Datolan''', '''Limovan''', '''Siaten''' and '''Zopicalma''' - Spain
*'''Zopiklon''' - Denmark, Norway, Sweden
*'''Amoban''' - Japan
*'''Hypnor''' - Egypt


==References==
<div class="references-small">
{{reflist|2}}
</div>


==External links==
* [http://www.mentalhealth.com/drug/p30-i01.html Detailed pharmacological information]
* [http://www.erowid.org/pharms/zopiclone/zopiclone_law1.pdf Scheduling recommendation] ([[Portable Document Format|PDF]] file)
* [http://www.deadiversion.usdoj.gov/fed_regs/rules/2005/fr0404.htm Details on scheduling]
* [http://www.erowid.org/pharms/zopiclone/zopiclone.html Erowid zopiclone vault]
* [http://www.non-benzodiazepines.org.uk/ Support for Zopiclone dependency/addiction]


{{Hypnotics and sedatives}}


[[Category:Cyclopyrrolones]]
<!--Category-->
[[Category:Hypnotics]]
[[Category:Sedatives]]


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Revision as of 03:06, 16 December 2014

Zopiclone
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Black Box Warning

ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Zopiclone is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Zopiclone in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Zopiclone in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Zopiclone in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Zopiclone in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Zopiclone in pediatric patients.

Contraindications

  • Condition1

Warnings

ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Zopiclone in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Zopiclone in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Zopiclone in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Zopiclone during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Zopiclone with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Zopiclone with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Zopiclone with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Zopiclone with respect to specific gender populations.

Race

There is no FDA guidance on the use of Zopiclone with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Zopiclone in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Zopiclone in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Zopiclone in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Zopiclone in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Zopiclone in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Zopiclone in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Zopiclone in the drug label.

Pharmacology

There is limited information regarding Zopiclone Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Zopiclone in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Zopiclone in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Zopiclone in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Zopiclone in the drug label.

How Supplied

Storage

There is limited information regarding Zopiclone Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Zopiclone |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Zopiclone |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Zopiclone in the drug label.

Precautions with Alcohol

  • Alcohol-Zopiclone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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{{#subobject: 

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