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)
Thinking abnormal19.10.03.001; 17.02.05.0230.000220%Not Available
Thirst14.03.02.007; 08.01.09.021--Not Available
Thrombophlebitis24.01.02.001--Not Available
Tinnitus04.04.01.002; 17.04.07.004--
Tongue disorder07.14.01.002--Not Available
Tongue oedema23.04.01.009; 10.01.05.008; 07.14.02.007--Not Available
Tremor17.01.06.0020.000330%
Urethritis20.07.02.001; 11.01.14.008--
Urinary incontinence20.02.02.010; 17.05.01.008--
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Uterine haemorrhage21.07.01.005; 24.07.03.004--
Vaginal haemorrhage24.07.03.005; 21.08.01.001--
Vaginal infection21.14.02.002; 11.01.10.002--
Vertigo17.02.12.002; 04.04.01.003--
Vestibular disorder04.04.02.001; 17.02.02.008--
Viral infection11.05.04.001--Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Musculoskeletal stiffness15.03.05.027--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Affect lability19.04.01.001--Not Available
Nuchal rigidity17.05.02.006; 15.05.04.005--Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Abnormal behaviour19.01.01.0010.000858%Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Ill-defined disorder08.01.03.049--Not Available
Abnormal sleep-related event19.02.03.009; 17.15.02.0070.000594%Not Available
Drug intolerance08.06.01.0130.000968%Not Available
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