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)
Hirsutism05.05.01.005; 23.02.04.001--
Hostility19.05.01.003--Not Available
Hyperacusis04.02.02.001; 17.04.03.003--Not Available
Hyperaesthesia23.03.03.080; 17.02.06.004--Not Available
Hypercholesterolaemia14.08.01.001--Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.0030.001497%
Hypertension24.08.02.001--
Hypertonia17.05.02.001; 15.05.04.007--Not Available
Hypoaesthesia23.03.03.081; 17.02.06.023--Not Available
Hypokalaemia14.05.03.002--
Hypokinesia17.01.02.009--Not Available
Hyporeflexia17.02.01.003--
Increased appetite14.03.01.003; 08.01.09.0270.000220%Not Available
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Injury12.01.08.004--Not Available
Insomnia17.15.03.002; 19.02.01.0020.002531%
Intentional self-injury19.12.01.002; 12.01.08.0360.000220%Not Available
Iritis10.02.01.022; 06.04.03.002--Not Available
Irritability19.04.02.013; 08.01.03.0110.000220%
Laryngitis11.01.13.001; 22.07.03.001--
Libido decreased21.03.02.005; 19.08.03.001--
Loss of consciousness17.02.04.0040.000330%Not Available
Lymphadenopathy01.09.01.002--Not Available
Malaise08.01.01.003--
Mania19.16.02.0020.000220%
Mastitis21.05.03.002; 11.01.02.001--
Melaena24.07.02.013; 07.12.02.004--Not Available
Memory impairment19.20.01.003; 17.03.02.0030.000484%
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