Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Eszopiclone
Drug ID BADD_D00837
Description Eszopiclone, marketed by Sepracor under the brand-name Lunesta, is a nonbenzodiazepine hypnotic drug used to treat insomnia. It is the active stereoisomer of zopiclone, belonging to the class of drugs known as _cyclopyrrolones_.[A179638,L6850] Cyclopyrrolone drugs demonstrate high efficacy and low toxicity[A179827], offering a safer alternative to other drugs used for insomnia. One major benefit of eszopiclone is that it is approved by the FDA for the long-term treatment of insomnia. This sets it apart from many other hypnotic sedatives, which are generally approved only for the relief of short-term (6-8 weeks) insomnia. Eszopiclone was initially approved by the FDA in 2004.[L6769]
Indications and Usage Eszopiclone is indicated for the treatment of insomnia.[L6769]
Marketing Status approved; investigational
ATC Code N05CF04
DrugBank ID DB00402
KEGG ID D02624
MeSH ID D000069582
PubChem ID 969472
TTD Drug ID D06ZII
NDC Product Code 80425-0067; 66039-847; 42043-320; 45865-829; 55700-581; 60760-511; 61919-033; 63187-970; 63402-191; 0378-5270; 65862-967; 65862-968; 68788-8387; 69452-348; 71205-384; 80425-0098; 55111-878; 63278-1059; 64330-044; 66022-0106; 43063-795; 47335-587; 60760-325; 63187-665; 68180-324; 68788-8077; 69452-347; 71205-633; 71335-0116; 71335-0148; 72189-099; 80425-0065; 66639-019; 33342-300; 50090-4202; 50436-3384; 0378-5272; 65862-969; 71205-236; 55111-629; 60429-633; 70518-1310; 70518-2979; 71205-581; 63285-831; 50090-3514; 55700-610; 60429-632; 60760-526; 61919-395; 63187-579; 63402-193; 63629-5319; 68462-382; 68788-7667; 71335-0005; 71335-0089; 80425-0062; 72761-013; 0093-5537; 50436-3383; 55700-621; 63187-817; 63402-190; 68462-383; 68788-7169; 71335-1662; 72789-067; 80425-0064; 80425-0168; 63285-830; 63285-832; 0093-5539; 33342-301; 43353-101; 47335-588; 55111-617; 61919-119; 68180-322; 68462-384; 71335-0574; 76420-026; 80425-0063; 0093-5538; 33342-299; 43353-097; 45865-828; 55111-619; 61919-991; 69452-349; 71335-2002; 71610-409; 42043-321; 42043-322; 45865-830; 47335-586; 63187-843; 0378-5271; 68180-323; 68788-7029; 71335-0512; 71335-0598; 71335-1794; 80425-0115; 60429-634; 70518-0815; 70518-3395; 70518-3576; 71205-513; 71335-9659; 76420-024; 76420-027; 80425-0066; 11722-057
UNII UZX80K71OE
Synonyms Eszopiclone | Lunesta | Estorra
Chemical Information
Molecular Formula C17H17ClN6O3
CAS Registry Number 138729-47-2
SMILES CN1CCN(CC1)C(=O)OC2C3=NC=CN=C3C(=O)N2C4=NC=C(C=C4)Cl
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Ear pain04.03.01.003--
Eczema23.03.04.006--
Epistaxis24.07.01.005; 22.04.03.001--
Erythema23.03.06.0010.000220%Not Available
Erythema multiforme23.03.01.003; 10.01.03.015--
Euphoric mood19.04.02.006--
Eyelid ptosis06.05.01.002; 17.17.02.004--Not Available
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.003--
Feeling abnormal08.01.09.0140.000220%Not Available
Flat affect19.04.01.004--Not Available
Furuncle23.11.02.009; 11.02.05.008--Not Available
Gait disturbance17.02.05.016; 15.03.05.013; 08.01.02.002--
Galactorrhoea21.05.02.002; 05.03.04.002--Not Available
Gastric ulcer07.04.03.002--
Gastritis07.08.02.001--
Gastrointestinal pain07.01.05.005--
Gout14.09.01.001; 15.01.06.001--Not Available
Gynaecomastia21.05.04.003; 05.05.02.003--
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.006--
Hallucination19.10.04.0030.000704%
Hangover08.01.09.0180.000748%Not Available
Headache17.14.01.001--
Heat stroke24.06.02.009; 12.05.01.001--Not Available
Hepatic function abnormal09.01.02.0010.000440%Not Available
Hepatitis09.01.07.004--Not Available
Hepatocellular injury09.01.07.008--Not Available
Hepatomegaly09.01.05.001--Not Available
Hernia08.01.04.001--Not Available
Herpes zoster23.11.05.005; 17.09.03.026; 11.05.02.003--
Hiccups22.12.01.001; 07.01.06.009--
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