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Also known as: 151319-34-5, Sonata, Cl-284846, Skp-1041, N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-n-ethylacetamide, Zal-846
Molecular Formula
C17H15N5O
Molecular Weight
305.33  g/mol
InChI Key
HUNXMJYCHXQEGX-UHFFFAOYSA-N
FDA UNII
S62U433RMH

Zaleplon
Zaleplon is a nonbenzodiazepine from the pyrazolopyrimidine class with hypnotic, sedative, anxiolytic, and muscle relaxant properties. Zaleplon interacts with the gamma-aminobutyric acid (GABA) -A receptor, thereby affecting the chloride channel ionophore complex and potentiating the inhibitory effects of GABA. In addition, zaleplon binds selectively to the brain omega-1 receptor situated on the alpha subunit of the GABA-A/chloride ion channel receptor complex and potentiates t-butyl-bicyclophosphorothionate (TBPS) binding.
Zaleplon is a gamma-Aminobutyric Acid A Receptor Agonist. The mechanism of action of zaleplon is as a GABA A Agonist. The physiologic effect of zaleplon is by means of Central Nervous System Depression.
1 2D Structure

Zaleplon

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide
2.1.2 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
2.1.3 InChI Key
HUNXMJYCHXQEGX-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCN(C1=CC=CC(=C1)C2=CC=NC3=C(C=NN23)C#N)C(=O)C
2.2 Other Identifiers
2.2.1 UNII
S62U433RMH
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 3'-(3-cyanopyrazolo(1,5-alpha)pyrimidin-7-yl)-n-ethylacetanilide

2. Cl 284,846

3. Cl 284846

4. Cl-284846

5. Cl284,846

6. L 846

7. L-846

8. N-(3-(3-cyanopyrazolo(1,5-a)pyrimidin-7-yl)phenyl)-n-ethylacetamide

9. Skp-1041

10. Sonata

11. Starnoc

12. Zelepion

2.3.2 Depositor-Supplied Synonyms

1. 151319-34-5

2. Sonata

3. Cl-284846

4. Skp-1041

5. N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-n-ethylacetamide

6. Zal-846

7. Cl 284,846

8. Ljc 10846

9. L846

10. Cl 284846

11. Ljc-10846

12. L-846

13. Dea No. 2781

14. Zaleplon Civ

15. 3'-(3-cyanopyrazolo(1,5-a)pyrimidin-7-yl)-n-ethylacetanilide

16. N-(3-(3-cyanopyrazolo(1,5-a)pyrimidin-7-yl)phenyl)-n-ethylacetamide

17. S62u433rmh

18. Chebi:10102

19. N-(3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl)-n-ethylacetamide

20. Ncgc00160525-01

21. Dsstox_cid_3748

22. Dsstox_rid_77183

23. Dsstox_gsid_23748

24. Zal 846

25. N-(3-{3-cyanopyrazolo[1,5-a]pyrimidin-7-yl}phenyl)-n-ethylacetamide

26. Staccato-zaleplon

27. Smr000238180

28. Sonata (tn)

29. Cas-151319-34-5

30. Unii-s62u433rmh

31. Zaleplon Ap

32. Zaleplon [usan:usp:inn:ban]

33. 3'-(3-cyanopyrazolo(1,5-alpha)pyrimidin-7-yl)-n-ethylacetanilide

34. Az-007

35. Zaleplon [usan]

36. Zaleplon [inn]

37. Zaleplon [jan]

38. Zaleplon [mi]

39. Zaleplon [vandf]

40. Zaleplon [mart.]

41. Zaleplon [who-dd]

42. Acetamide, N-(3-(3-cyanopyrazolo(1,5-a)pyrimidin-7-yl)phenyl)-n-ethyl-

43. Zaleplon (jan/usp/inn)

44. Chembl1521

45. Zaleplon [ema Epar]

46. Schembl29118

47. Mls000759451

48. Mls001424238

49. Bidd:gt0046

50. Zaleplon [orange Book]

51. Zaleplon Civ [usp-rs]

52. Gtpl4345

53. Zinc6300

54. Dtxsid5023748

55. Zaleplon [usp Monograph]

56. Bdbm86521

57. Zaleplon 1.0 Mg/ml In Methanol

58. Hms2052j11

59. Hms3394j11

60. Hms3713h08

61. Act04427

62. Bcp21340

63. Cas_5719

64. Nsc_5719

65. Tox21_111872

66. N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-n-ethyl-acetamide

67. Zaleplon, >=98% (hplc), Solid

68. Acetamide, N-(3-(3-cyanopyrazolo(1,5-alpha)pyrimidin-7-yl)phenyl)-n-ethyl-

69. Akos000280863

70. Tox21_111872_1

71. Ac-2082

72. Ccg-101187

73. Db00962

74. Nc00437

75. Ss-4571

76. Ncgc00160525-02

77. Hy-14265

78. Db-015068

79. A12993

80. C07484

81. D00530

82. Ab00640003_03

83. 319z345

84. A809159

85. Q145052

86. Sr-01000759426

87. Sr-01000759426-3

88. Zaleplon, United States Pharmacopeia (usp) Reference Standard

89. N-[3-(cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-n-ethylacetamide

90. 3'-(3-cyanopyrazolo(1,5-.alpha.)pyrimidin-7-yl)-n-ethylacetanilide

91. N-[3-(3-cyanopyrazolo-[1,5-a]-pyrimidin-7-yl)-phenyl]-n-ethyl Acetamide

92. Acetamide, N-(3-(3-cyanopyrazolo(1,5-.alpha.)pyrimidin-7-yl)phenyl)-n-ethyl-

93. Zaleplon Solution, 1.0 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

94. 1007130-22-4

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 305.33 g/mol
Molecular Formula C17H15N5O
XLogP31
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count4
Rotatable Bond Count3
Exact Mass305.12766012 g/mol
Monoisotopic Mass305.12766012 g/mol
Topological Polar Surface Area74.3 Ų
Heavy Atom Count23
Formal Charge0
Complexity487
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameSonata
PubMed HealthZaleplon (By mouth)
Drug ClassesNonbarbiturate Hypnotic
Drug LabelZaleplon is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class. The chemical name of zaleplon is N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide. Its empirical formula is C17H15N5O, and its molecular weight is 305.34....
Active IngredientZaleplon
Dosage FormCapsule
RouteOral
Strength5mg; 10mg
Market StatusPrescription
CompanyPfizer

2 of 4  
Drug NameZaleplon
PubMed HealthZaleplon (By mouth)
Drug ClassesNonbarbiturate Hypnotic
Drug LabelZaleplon is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class. The chemical name of zaleplon is N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide. Its empirical formula is C17H15N5O, and its molecular weight is 305.34....
Active IngredientZaleplon
Dosage FormCapsule
RouteOral
Strength5mg; 10mg
Market StatusPrescription
CompanyUpsher Smith; Unichem; Aurobindo Pharma; Cipla; Hikma Pharms; Roxane; Teva Pharms; Orchid Hlthcare; Mylan

3 of 4  
Drug NameSonata
PubMed HealthZaleplon (By mouth)
Drug ClassesNonbarbiturate Hypnotic
Drug LabelZaleplon is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class. The chemical name of zaleplon is N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide. Its empirical formula is C17H15N5O, and its molecular weight is 305.34....
Active IngredientZaleplon
Dosage FormCapsule
RouteOral
Strength5mg; 10mg
Market StatusPrescription
CompanyPfizer

4 of 4  
Drug NameZaleplon
PubMed HealthZaleplon (By mouth)
Drug ClassesNonbarbiturate Hypnotic
Drug LabelZaleplon is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class. The chemical name of zaleplon is N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide. Its empirical formula is C17H15N5O, and its molecular weight is 305.34....
Active IngredientZaleplon
Dosage FormCapsule
RouteOral
Strength5mg; 10mg
Market StatusPrescription
CompanyUpsher Smith; Unichem; Aurobindo Pharma; Cipla; Hikma Pharms; Roxane; Teva Pharms; Orchid Hlthcare; Mylan

4.2 Drug Indication

For the treatment of short-term treatment of insomnia in adults.


FDA Label


Sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Zaleplon is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class and is indicated for the short-term treatment of insomnia. While Zaleplon is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties, it interacts with the gamma-aminobutyric acid-benzodiazepine (GABABZ) receptor complex. Subunit modulation of the GABABZ receptor chloride channel macromolecular complex is hypothesized to be responsible for some of the pharmacological properties of benzodiazepines, which include sedative, anxiolytic, muscle relaxant, and anticonvulsive effects in animal models. Zaleplon also binds selectively to the CNS GABAA-receptor chloride ionophore complex at benzodiazepine(BZ) omega-1 (BZ1, 1) receptors.


5.2 MeSH Pharmacological Classification

Anticonvulsants

Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)


Hypnotics and Sedatives

Drugs used to induce drowsiness or sleep or to reduce psychological excitement or anxiety. (See all compounds classified as Hypnotics and Sedatives.)


GABA Modulators

Substances that do not act as agonists or antagonists but do affect the GAMMA-AMINOBUTYRIC ACID receptor-ionophore complex. GABA-A receptors (RECEPTORS, GABA-A) appear to have at least three allosteric sites at which modulators act: a site at which BENZODIAZEPINES act by increasing the opening frequency of GAMMA-AMINOBUTYRIC ACID-activated chloride channels; a site at which BARBITURATES act to prolong the duration of channel opening; and a site at which some steroids may act. GENERAL ANESTHETICS probably act at least partly by potentiating GABAergic responses, but they are not included here. (See all compounds classified as GABA Modulators.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
ZALEPLON
5.3.2 FDA UNII
S62U433RMH
5.3.3 Pharmacological Classes
GABA A Agonists [MoA]; gamma-Aminobutyric Acid A Receptor Agonist [EPC]; Central Nervous System Depression [PE]
5.4 ATC Code

N05CF03


N - Nervous system

N05 - Psycholeptics

N05C - Hypnotics and sedatives

N05CF - Benzodiazepine related drugs

N05CF03 - Zaleplon


5.5 Absorption, Distribution and Excretion

Absorption

Absorption Zaleplon is rapidly and almost completely absorbed following oral administration.


Route of Elimination

Zaleplon is metabolized primarily by the liver and undergoes significant presystemic metabolism. After oral administration, zaleplon is extensively metabolized, with less than 1% of the dose excreted unchanged in urine. Renal excretion of unchanged zaleplon accounts for less than 1% of the administered dose.


Volume of Distribution

1.4 L/kg


Clearance

1 L/h/kg


5.6 Metabolism/Metabolites

Zaleplon is primarily metabolized by aldehyde oxidase.


Zaleplon has known human metabolites that include Dementhylazed-zaleplon.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560


5.7 Biological Half-Life

Approximately 1 hour


5.8 Mechanism of Action

Zaleplon exerts its action through subunit modulation of the GABABZ receptor chloride channel macromolecular complex. Zaleplon also binds selectively to the brain omega-1 receptor located on the alpha subunit of the GABA-A/chloride ion channel receptor complex and potentiates t-butyl-bicyclophosphorothionate (TBPS) binding.


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22-Jul-2021
21-Sep-2024
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CAPSULE;ORAL - 10MG

USFDA APPLICATION NUMBER - 20859

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DOSAGE - CAPSULE;ORAL - 5MG

USFDA APPLICATION NUMBER - 20859

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ABOUT THIS PAGE

Zaleplon Manufacturers

A Zaleplon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zaleplon, including repackagers and relabelers. The FDA regulates Zaleplon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zaleplon API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Zaleplon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Zaleplon Suppliers

A Zaleplon supplier is an individual or a company that provides Zaleplon active pharmaceutical ingredient (API) or Zaleplon finished formulations upon request. The Zaleplon suppliers may include Zaleplon API manufacturers, exporters, distributors and traders.

click here to find a list of Zaleplon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Zaleplon USDMF

A Zaleplon DMF (Drug Master File) is a document detailing the whole manufacturing process of Zaleplon active pharmaceutical ingredient (API) in detail. Different forms of Zaleplon DMFs exist exist since differing nations have different regulations, such as Zaleplon USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Zaleplon DMF submitted to regulatory agencies in the US is known as a USDMF. Zaleplon USDMF includes data on Zaleplon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zaleplon USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Zaleplon suppliers with USDMF on PharmaCompass.

Zaleplon WC

A Zaleplon written confirmation (Zaleplon WC) is an official document issued by a regulatory agency to a Zaleplon manufacturer, verifying that the manufacturing facility of a Zaleplon active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Zaleplon APIs or Zaleplon finished pharmaceutical products to another nation, regulatory agencies frequently require a Zaleplon WC (written confirmation) as part of the regulatory process.

click here to find a list of Zaleplon suppliers with Written Confirmation (WC) on PharmaCompass.

Zaleplon NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Zaleplon as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Zaleplon API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Zaleplon as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Zaleplon and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zaleplon NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Zaleplon suppliers with NDC on PharmaCompass.

Zaleplon GMP

Zaleplon Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Zaleplon GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Zaleplon GMP manufacturer or Zaleplon GMP API supplier for your needs.

Zaleplon CoA

A Zaleplon CoA (Certificate of Analysis) is a formal document that attests to Zaleplon's compliance with Zaleplon specifications and serves as a tool for batch-level quality control.

Zaleplon CoA mostly includes findings from lab analyses of a specific batch. For each Zaleplon CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Zaleplon may be tested according to a variety of international standards, such as European Pharmacopoeia (Zaleplon EP), Zaleplon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zaleplon USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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