Zaleplon

Zaleplon
Clinical data
Trade names	Sonata, others
AHFS/Drugs.com	Monograph
MedlinePlus	a601251
License data	US DailyMed: Zaleplon;
Addiction; liability	Moderate
Routes of; administration	By mouth
Drug class	nonbenzodiazepine
ATC code	N05CF03 (WHO) ;
Legal status
Legal status	BR: Class B1 (Psychoactive drugs); UK: Class C; US: WARNINGSchedule IV;
Pharmacokinetic data
Bioavailability	30% (oral)
Metabolism	Liver aldehyde oxidase (91%), CYP3A4 (9%)
Metabolites	No active metabolites
Onset of action	10 to 30 minutes
Elimination half-life	1 hr
Duration of action	Approximately 4 to 6 hours
Excretion	Kidney
Identifiers
	IUPAC name N-(3-(3-cyanopyrazolo[1,5-a] pyrimidin-7-yl)phenyl)-N-ethylacetamide;
CAS Number	151319-34-5 ;
PubChem CID	5719;
IUPHAR/BPS	4345;
DrugBank	DB00962 ;
ChemSpider	5517 ;
UNII	S62U433RMH;
KEGG	D00530 ;
ChEBI	CHEBI:10102 ;
ChEMBL	ChEMBL1521 ;
CompTox Dashboard (EPA)	DTXSID5023748 ;
ECHA InfoCard	100.126.674
Chemical and physical data
Formula	C17H15N5O
Molar mass	305.341 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES CCN(C(C)=O)c1cccc(-c2ccnc3c(C#N)cnn23)c1;
	InChI InChI=1S/C17H15N5O/c1-3-21(12(2)23)15-6-4-5-13(9-15)16-7-8-19-17-14(10-18)11-20-22(16)17/h4-9,11H,3H2,1-2H3 ; Key:HUNXMJYCHXQEGX-UHFFFAOYSA-N ;
	(verify)

Zaleplon, sold under the brand name Sonata among others, is a sedative and hypnotic which is used to treat insomnia. It is a nonbenzodiazepine or Z-drug of the pyrazolopyrimidine class.^[10] It was developed by King Pharmaceuticals and approved for medical use in the United States in 1999.^[3]

^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
^ Anvisa (31 March 2023). "RDC Nº 784 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial" [Collegiate Board Resolution No. 784 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control] (in Brazilian Portuguese). Diário Oficial da União (published 4 April 2023). Archived from the original on 3 August 2023. Retrieved 16 August 2023.
^ ^a ^b "Sonata (zaleplon) Capsules CIV". DailyMed. U.S. National Library of Medicine. Retrieved 21 March 2023.
^ ^a ^b Rosen AS, Fournié P, Darwish M, Danjou P, Troy SM (April 1999). "Zaleplon pharmacokinetics and absolute bioavailability". Biopharmaceutics & Drug Disposition. 20 (3): 171–175. doi:10.1002/(sici)1099-081x(199904)20:3<171::aid-bdd169>3.0.co;2-k. PMID 10211871.
^ Coke JM, Edwards MD (April 2009). "Minimal and moderate oral sedation in the adult special needs patient". Dental Clinics of North America. 53 (2): 221–30, viii. doi:10.1016/j.cden.2008.12.005. PMID 19269393. Zaleplon (Sonata) has the shortest half-life of the Z-drugs of 1 hour and reaches peak plasma level in 1 hour. It is rapidly absorbed in under1 hour and has no active metabolites. The recommended adult dose is 5–20 mg.
^ ^a ^b Bechtel LK, Holstege CP (May 2007). "Criminal poisoning: drug-facilitated sexual assault". Emergency Medicine Clinics of North America. 25 (2): 499–525, abstract x. doi:10.1016/j.emc.2007.02.008. PMID 17482030. Zaleplon is available as an immediate-release tablet or capsule. An average oral dose of 10 to 15 mg has a rapid onset of clinical symptoms of approximately 10 to 30 minutes. Although the t1/2 for zaleplon is about 1 hour, the duration of clinical effects may persist for greater than 6 hours. This persistence may be because of the higher affinity of zaleplon for specific α2 and α3 subunits of the GABA receptor, unlike zolpidem or zopiclone [74].
^ "SONATA - zaleplon capsule". DailyMed. U.S. National Library of Medicine. Retrieved 31 August 2024. Do not take Sonata unless you are able to get 4 or more hours of sleep before you must be active again. DO NOT use alcohol while taking Sonata or any other sleep medicine. Be sure to tell your physician if you suffer from depression. Sonata works very quickly. You should only take Sonata immediately before going to bed or after you have gone to bed and are having difficulty falling asleep. For Sonata to work best, you should not take Sonata with or immediately after a high-fat/heavy meal. Some people should start with the lowest dose (5 mg) of Sonata; these include the elderly (ie, ages 65 and over) and people with liver disease.
^ Khouzam HR, Gill TS, Tan DT (2007). "The Patient with Posttraumatic Stress Disorder". Handbook of Emergency Psychiatry. Elsevier. p. 453–473. doi:10.1016/b978-0-323-04088-4.50026-x. ISBN 978-0-323-04088-4. The adult dose is 10 mg, and 5 mg for geriatric patients.
^ "20859 S009, 011 FDA Approved Labeling Text 12.10.07" (PDF). FDA. Retrieved 21 March 2023.
^ Elie R, Rüther E, Farr I, Emilien G, Salinas E (August 1999). "Sleep latency is shortened during 4 weeks of treatment with zaleplon, a novel nonbenzodiazepine hypnotic. Zaleplon Clinical Study Group". The Journal of Clinical Psychiatry. 60 (8): 536–44. doi:10.4088/JCP.v60n0806. PMID 10485636.

[FDA-AllBoxedWarnings-1] "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.

[2] Anvisa (31 March 2023). "RDC Nº 784 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial" [Collegiate Board Resolution No. 784 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control] (in Brazilian Portuguese). Diário Oficial da União (published 4 April 2023). Archived from the original on 3 August 2023. Retrieved 16 August 2023.

[Sonata_FDA_label-3] "Sonata (zaleplon) Capsules CIV". DailyMed. U.S. National Library of Medicine. Retrieved 21 March 2023.

[pharmokinetics-4] Rosen AS, Fournié P, Darwish M, Danjou P, Troy SM (April 1999). "Zaleplon pharmacokinetics and absolute bioavailability". Biopharmaceutics & Drug Disposition. 20 (3): 171–175. doi:10.1002/(sici)1099-081x(199904)20:3<171::aid-bdd169>3.0.co;2-k. PMID 10211871.

[e689-5] Coke JM, Edwards MD (April 2009). "Minimal and moderate oral sedation in the adult special needs patient". Dental Clinics of North America. 53 (2): 221–30, viii. doi:10.1016/j.cden.2008.12.005. PMID 19269393. Zaleplon (Sonata) has the shortest half-life of the Z-drugs of 1 hour and reaches peak plasma level in 1 hour. It is rapidly absorbed in under1 hour and has no active metabolites. The recommended adult dose is 5–20 mg.

[s070-6] Bechtel LK, Holstege CP (May 2007). "Criminal poisoning: drug-facilitated sexual assault". Emergency Medicine Clinics of North America. 25 (2): 499–525, abstract x. doi:10.1016/j.emc.2007.02.008. PMID 17482030. Zaleplon is available as an immediate-release tablet or capsule. An average oral dose of 10 to 15 mg has a rapid onset of clinical symptoms of approximately 10 to 30 minutes. Although the t1/2 for zaleplon is about 1 hour, the duration of clinical effects may persist for greater than 6 hours. This persistence may be because of the higher affinity of zaleplon for specific α2 and α3 subunits of the GABA receptor, unlike zolpidem or zopiclone [74].

[y784-7] "SONATA - zaleplon capsule". DailyMed. U.S. National Library of Medicine. Retrieved 31 August 2024. Do not take Sonata unless you are able to get 4 or more hours of sleep before you must be active again. DO NOT use alcohol while taking Sonata or any other sleep medicine. Be sure to tell your physician if you suffer from depression. Sonata works very quickly. You should only take Sonata immediately before going to bed or after you have gone to bed and are having difficulty falling asleep. For Sonata to work best, you should not take Sonata with or immediately after a high-fat/heavy meal. Some people should start with the lowest dose (5 mg) of Sonata; these include the elderly (ie, ages 65 and over) and people with liver disease.

[h714-8] Khouzam HR, Gill TS, Tan DT (2007). "The Patient with Posttraumatic Stress Disorder". Handbook of Emergency Psychiatry. Elsevier. p. 453–473. doi:10.1016/b978-0-323-04088-4.50026-x. ISBN 978-0-323-04088-4. The adult dose is 10 mg, and 5 mg for geriatric patients.

[fda-9] "20859 S009, 011 FDA Approved Labeling Text 12.10.07" (PDF). FDA. Retrieved 21 March 2023.

[10] Elie R, Rüther E, Farr I, Emilien G, Salinas E (August 1999). "Sleep latency is shortened during 4 weeks of treatment with zaleplon, a novel nonbenzodiazepine hypnotic. Zaleplon Clinical Study Group". The Journal of Clinical Psychiatry. 60 (8): 536–44. doi:10.4088/JCP.v60n0806. PMID 10485636.

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