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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
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
Molecular Weight | 305.33 g/mol |
---|---|
Molecular Formula | C17H15N5O |
XLogP3 | 1 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 3 |
Exact Mass | 305.12766012 g/mol |
Monoisotopic Mass | 305.12766012 g/mol |
Topological Polar Surface Area | 74.3 Ų |
Heavy Atom Count | 23 |
Formal Charge | 0 |
Complexity | 487 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 4 | |
---|---|
Drug Name | Sonata |
PubMed Health | Zaleplon (By mouth) |
Drug Classes | Nonbarbiturate Hypnotic |
Drug Label | Zaleplon 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 Ingredient | Zaleplon |
Dosage Form | Capsule |
Route | Oral |
Strength | 5mg; 10mg |
Market Status | Prescription |
Company | Pfizer |
2 of 4 | |
---|---|
Drug Name | Zaleplon |
PubMed Health | Zaleplon (By mouth) |
Drug Classes | Nonbarbiturate Hypnotic |
Drug Label | Zaleplon 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 Ingredient | Zaleplon |
Dosage Form | Capsule |
Route | Oral |
Strength | 5mg; 10mg |
Market Status | Prescription |
Company | Upsher Smith; Unichem; Aurobindo Pharma; Cipla; Hikma Pharms; Roxane; Teva Pharms; Orchid Hlthcare; Mylan |
3 of 4 | |
---|---|
Drug Name | Sonata |
PubMed Health | Zaleplon (By mouth) |
Drug Classes | Nonbarbiturate Hypnotic |
Drug Label | Zaleplon 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 Ingredient | Zaleplon |
Dosage Form | Capsule |
Route | Oral |
Strength | 5mg; 10mg |
Market Status | Prescription |
Company | Pfizer |
4 of 4 | |
---|---|
Drug Name | Zaleplon |
PubMed Health | Zaleplon (By mouth) |
Drug Classes | Nonbarbiturate Hypnotic |
Drug Label | Zaleplon 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 Ingredient | Zaleplon |
Dosage Form | Capsule |
Route | Oral |
Strength | 5mg; 10mg |
Market Status | Prescription |
Company | Upsher Smith; Unichem; Aurobindo Pharma; Cipla; Hikma Pharms; Roxane; Teva Pharms; Orchid Hlthcare; Mylan |
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.
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.
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.)
N05CF03
N - Nervous system
N05 - Psycholeptics
N05C - Hypnotics and sedatives
N05CF - Benzodiazepine related drugs
N05CF03 - Zaleplon
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
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
Approximately 1 hour
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.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17565
Submission : 2004-07-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20877
Submission : 2007-09-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19398
Submission : 2006-04-26
Status : Active
Type : II
Date of Issue : 2022-06-06
Valid Till : 2025-06-10
Written Confirmation Number : WC-0017
Address of the Firm :
NDC Package Code : 65862-197
Start Marketing Date : 2024-01-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-02
Pay. Date : 2013-09-25
DMF Number : 27568
Submission : 2013-09-25
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-06-25
Written Confirmation Number : WC-0107
Address of the Firm :
NDC Package Code : 64330-054
Start Marketing Date : 2018-01-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22572
Submission : 2009-02-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21482
Submission : 2008-04-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18022
Submission : 2005-01-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19015
Submission : 2005-12-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16785
Submission : 2003-08-20
Status : Inactive
Type : II
NDC Package Code : 51846-1026
Start Marketing Date : 2017-11-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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ABOUT THIS PAGE
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.
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.
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.
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.
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).
The FDA updates the NDC directory daily. The NDC numbers for Zaleplon API and other APIs are published in this directory by the FDA.
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.
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 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.
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).
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