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ZaleplonThis page contains recent news articles, when available, and an overview of Zaleplon but does not offer medical advice. You should contact your physician with regard to any health issues or concerns.Overview: Zaleplon (when available) 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 binds selectively to the brain alpha subunit of the GABA A omega-1 receptor. For the treatment of short-term treatment of insomnia in adults Mechanism Of Action: Zaleplon exerts its action through subunit modulation of the GABABZ receptor chloride channel macromolecular complex.Zaleplon binds selectively to the brain alomega-1 receptor situated on the alpha subunit of the GABA-A/chloride ion channel receptor complex and potentiates t-butyl-bicyclophosphorothionate (TBPS) binding. News Articles on Zaleplon From the Los Angeles Times - Mar 30, 2009 Now the most popular prescription sleep medications, the class includes Ambien (zolpidem), Sonata (zaleplon) and Lunesta (eszopiclone). Chicago Tribune C21 BioVentures 2009 Presenter Profiles - Apr 6, 2009 SkyePharma for worldwide development and commercialization of a controlled-release oral formulation of zaleplon, a non-benzodiazepine hypnotic agent, MarketWatch (press release) Heightened Impairment Risk Seen with Sleep Aids - Mar 30, 2009 ...in North America and Europe take hypnotic sleep aids, the most common being the benzodiazepine-like drugs zolpidem, zopiclone, and zaleplon (Sonata). MedPage Today 불면ì¦?으로 â€˜ìž ëª»ë“œëŠ” 밤’ - Apr 6, 2009 ...최근 ì?¸ê¸° ì²˜ë°©ì „ìœ¼ë¡œ ì•Œë ¤ì§„ ì— ë¹„ì—”(Ambien, 성분명 zolpidem), 소나타(Sonata, 성분명 zaleplon), 루네스타(Lunesta, 성분명 eszopiclone) 등ì?´ 바로 그들. 미주 한국일보 10-K: ALEXZA PHARMACEUTICALS INC. - Mar 10, 2009 AZ-007 (Staccato zaleplon). We are developing AZ-007 for the treatment of insomnia in patients who have difficulty falling asleep, including patients who MarketWatch (press release) Best Practices: An Intervention to Promote Evidence-Based ... - Feb 27, 2009 ...clonazepam, diphenhydramine, haloperidol, hydroxyzine, lorazepam, temazepam, trazodone, and zaleplon. Although use of these medications was not examined Psychiatric Services (subscription) Alexza to Announce 2008 Financial Results and Update Its Clinical ... - Mar 9, 2009 Product candidates that have completed Phase 1 testing are AZ-003 (Staccato fentanyl) for the treatment of breakthrough pain and AZ-007 (Staccato zaleplon) PharmaLive.com (press release) Diagnosis and Treatment of Sleep Disorders in Older Adults - Feb 25, 2009 The newer benzodiazepine receptor agonists (eg, zolpidem, zaleplon, eszopiclone) have all been tested in older adults and have been shown to be effective Focus (subscription) è¶…å¤¯å®‰çœ è—¥æœä¾†æ™®éš†åˆ—四級管制藥 - Feb 23, 2009 ...〔記者王昶閔ï¼?å?°åŒ—å ±å°Žã€•è¡›ç”Ÿç½²ç®¡åˆ¶è—¥å“?管ç?†å±€æœ€è¿‘é ?告將把電å?æ¥è¼ªç?æ—?ã€?空ä¸é£›äººæ„›ç”¨çš„å®‰çœ è—¥æœä¾†æ™®éš†ï¼ˆZaleplon,å?–自網路)列為第四級管制藥å“?ï¼Œå°‡åš´æ ¼æŽ§ç®¡æ¥è€…çš„ yam天空新聞 Alexza's Corporate Presentation to be Webcast at the 11th Annual ... - Feb 3, 2009 Product candidates that have completed Phase 1 testing are AZ-003 (Staccato fentanyl) for the treatment of breakthrough pain and AZ-007 (Staccato zaleplon) PR Newswire (press release), Once-Daily Quetiapine XR Monotherapy Effective and Well Tolerated ... - Jan 27, 2009 Concomitant psychoactive drugs allowed were lorazepam, zolpidem tartrate, zaleplon, zopicione, and chloral hydrate. Mean ages were 39.9 years in the DG News Alexza Initiates AZ-104 (Staccato(R) Loxapine) Phase 2b Clinical ... - Jan 20, 2009 ...of breakthrough pain, which is partnered with Endo Pharmaceuticals in North America , and AZ-007 (Staccato zaleplon) for the treatment of insomnia. PR Newswire (press release), Alexza Consolidates Operations to Focus Resources on AZ-004 ... - Jan 29, 2009 Product candidates that have completed Phase 1 testing are AZ-003 (Staccato fentanyl) for the treatment of breakthrough pain and AZ-007 (Staccato zaleplon) Earthtimes (press release), Alexza Completes Enrollment in Second Phase 3 Clinical Trial With ... - Oct 16, 2008 ...of breakthrough pain, which is partnered with Endo Pharmaceuticals in North America , and AZ-007 (Staccato zaleplon) for the treatment of insomnia. Earthtimes (press release), Alexza's Corporate Presentation to be Webcast at the Third Annual ... - Oct 1, 2008 ...of breakthrough pain, which is partnered with Endo Pharmaceuticals in North America, and AZ-007 (Staccato zaleplon) for the treatment of insomnia. PR-CANADA.net (press release), Commonly Abused Prescription Medications- CNS Depressants - Sep 28, 2008 Newer sleep medications, such as zolpidem (Ambien), zaleplon (Sonata), and eszopiclone (Lunesta), are now more commonly prescribed to treat sleep disorders. TransWorldNews (press release), Alexza Pharmaceuticals, Inc. Q2 2008 Earnings Call Transcript - Sep 2, 2008 We also read out positive initial results of the Phase 1 study with AZ-007, which is Staccato zaleplon, and is being developed for the treatment of insomnia Seeking Alpha, Prescription Sleeping Pill Use Tied to Cancer - Aug 18, 2008 The effects of 556 person-years of taking either zaleplon (Sonata), Eszopiclone (Lunesta), ramelteon (Rozerem) and zolpidem (Ambien) were assessed, MarketWatch Alexza's AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary ... - Sep 2, 2008 ...of breakthrough pain, which is partnered with Endo Pharmaceuticals in North America, and AZ-007 (Staccato zaleplon) for the treatment of insomnia. MarketWatch Older People in Danger from Common Drugs - Aug 28, 2008 Shorter-acting drugs such as zaleplon (Sonata) can be an alternative as well as reviewing and perhaps changing sleeping habits. • Bisacodyl (Dulcolax) is a NewsMax.com, Alexza Pharmaceuticals Announces Upcoming Webcasts and Conference ... - Aug 27, 2008 ...of breakthrough pain, which is partnered with Endo Pharmaceuticals in North America , and AZ-007 (Staccato zaleplon) for the treatment of insomnia. Earthtimes (press release), Efficacy, Safety, and Tolerability of Desvenlafaxine 50 Mg/Day and ... - Aug 28, 2008 ...anxiolytics, MAOIs and other antidepressants, 14 days; sedative-hypnotics other than zaleplon or Zolpidem, herbal products intended to treat anxiety, RedOrbit, ìˆ˜ë©´ì œ ìž?주 먹는 사람 'ì•”' 발병 위험 높다 - Aug 19, 2008 20ì?¼ ìƒŒë””ì• ì?´ê³ Scripps Clinic 수면센터 연구팀ì?´ 'ìˆ˜ë©´ì—°êµ¬ì €ë„?'ì—? ë°?힌 ìž˜ë ˆí”„ë¡ (Zaleplon), 조피í?´ë¡ (Zopiclon), 졸피뎀(Zolpidem) 등 ìˆ˜ë©´ì œë¥¼ 복용한 556명과 마ì?´ë?°ì?¼ë¦¬, ìˆ˜ë©´ì œ ìž?주 복용하면 발암 í™•ë¥ ë†’ì•„ì§„ë‹¤ - Aug 19, 2008 ...피험ìž?들ì?´ 복용한 ìˆ˜ë©´ì œëŠ” ‘소나타’(Sonata, zaleplon), ‘루네스타’(Lunesta, eszopiclone), â€˜ë¡œì œë ˜â€™(Rozerem, ramelteon), ‘앰비엔’(Ambien, zolpidem) 등ì?´ì—ˆë‹¤. 메디파나뉴스, Aurobindo Pharma gets US FDA approval for Zaleplon capsules - Jun 10, 2008 10 Jun, 2008, 1428 hrs IST, PTI MUMBAI: Pharmaceutical firm Aurobindo Pharma on Tuesday said it has received US regulatory approval to market Zaleplon Economic Times, Unichem Lab. Receives Final Approval From US FDA For Zaleplon Capsules - Jun 11, 2008 ...(RTTNews) - Wednesday, Unichem Laboratories stated that the company received final approval from US FDA for Zaleplon capsules of 5 mg and 10 mg strengths. RTT News, Mylan Granted Final Approval for Zaleplon Capsules - Jun 10, 2008 Mylan has announced that its subsidiary, Genpharm ULC, has received final approval from the FDA for its abbreviated new drug application for Zaleplon RedOrbit, Unichem gets quality certificate from European Directorate - Jun 13, 2008 Recently, the company received final approval from US Food & Drug Administration for Zaleplon Capsules in the strengths of 5 mg and 10 mg. Economic Times, Mylan Partners on MS Drug Distribution, Launches Insomnia Product - Jun 17, 2008 Word of the agreement came a day after Mylan subsidiary Genpharm won final FDA approval for its ANDA for zaleplon capsules 5 and 10 mg, a treatment for FDA news (subscription), Mylan wins lawsuit against AstraZeneca - Jun 11, 2008 In related news, Mylan yesterday announced that final approval for an Abbreviated New Drug Application for Zaleplon Capsules has been given by the US Food Hays Pharma, Business news briefs - Jun 10, 2008 Mylan Inc. said it received Food and Drug Administration approval for zaleplon, the generic version of King Pharmaceuticals' Sonata capsules. Pittsburgh Post Gazette, Mylan gets federal OK for generic Sonata - Jun 9, 2008 Six other pharmaceutical companies have received FDA approval of the generic drug, called zaleplon, according to the regulatory agency's Web site. MSN Money Unichem Laboratories gains on US FDA approval for plant - Jun 24, 2008 On 11 June 2008, the company received final approval from US Food and Drug Administration (US FDA) for zaleplon capsules in 5 and 10-milligram strengths. NDTV.com, Alexza's Corporate Presentation to be Webcast at the Piper Jaffray ... - Jun 20, 2008 ...of breakthrough pain, which is partnered with Endo Pharmaceuticals in North America, and AZ-007 (Staccato zaleplon) for the treatment of insomnia. FOXBusiness Unichem Lab inches ahead on European certification for plant - Jun 16, 2008 On 11 June 2008, Unichem Laboratories received final approval from US Food and Administration (USFDA) for zaleplon capsules in 5 and 10-milligram strengths. NDTV.com, *TOP NEWS* India June 11 - Jun 11, 2008 ...in '09 profit [nBOM132228] Unichem Labs gets US nod for zaleplon capsules [nBMB001957] Ratnamani Metals to consider stock split [nBMB001958] JSW Steel's Reuters India, Mylan Announces Final FDA Approval for Zaleplon Capsules - Jun 9, 2008 Zaleplon Capsules are the generic version of King Pharmaceuticals' Sonata(R) Capsules, which had US sales of approximately $88 million for the 12 months PharmaLive.com (press release), Mylan Announces Final FDA Approval for Zaleplon Capsules - Jun 9, 2008 Fundamental data is provided by Zacks Investment Research and market data is provided by AlphaTrade. All information provided "as is" for informational istockAnalyst.com, Search this blog - Jun 23, 2008 There are four other drugs that they are testing in the device, including fentanyl, prochlorperazine, loxapine, and zaleplon. They have suspended their ScienceBlogs Bulls make up some ground - Jun 9, 2008 Aurobindo Pharma has surged by over 5% to Rs285 after the company announced that it has secured final approval for Zaleplon Capsules. India Infoline.com, Alexza Announces Preliminary Results From its AZ-002 (Staccato(R ... - Jun 9, 2008 ...of breakthrough pain, which is partnered with EndoPharmaceuticals in North America , and AZ-007 (Staccato zaleplon) for thetreatment of insomnia. istockAnalyst.com, Alexza Announces Preliminary Results From its AZ-002 (Staccato(R ... - Jun 9, 2008 ...of breakthrough pain, which is partnered with Endo Pharmaceuticals in North America , and AZ-007 (Staccato zaleplon) for the treatment of insomnia. Earthtimes (press release), Alexza Completes Enrollment in Phase 3 Clinical Trial with AZ-004 ... - Jun 10, 2008 ...of breakthrough pain, which is partnered with Endo Pharmaceuticalsin North America, and AZ-007 (Staccato zaleplon) for the treatment ofinsomnia. FierceBiotech, Alexza Completes Enrollment in Phase 3 Clinical Trial With AZ-004 ... - Jun 10, 2008 ...of breakthrough pain, which is partnered with Endo Pharmaceuticals in North America, and AZ-007 (Staccato zaleplon) for the treatment of insomnia. RedOrbit, Alexza Pharmaceuticals, Inc. Q1 2008 Earnings Call Transcript - May 12, 2008 We initiated completed enrollment and released initial positive results from our Phase I study with AZ-007 Staccato zaleplon for the treatment of insomnia. Seeking Alpha, Jeffrey S. Williams Rejoins Alexza Pharmaceuticals as President ... - May 20, 2008 ...of breakthrough pain, which is partnered with Endo Pharmaceuticals in North America, and AZ-007 (Staccato zaleplon) for the treatment of insomnia. FOXBusiness Carlos A. Parra Joins Alexza Pharmaceuticals as Vice President ... - May 15, 2008 ...of breakthrough pain, which is partnered with Endo Pharmaceuticals in North America , and AZ-007 (Staccato zaleplon) for the treatment of insomnia. Earthtimes (press release), Carlos A. Parra Joins Alexza Pharmaceuticals as Vice President ... - May 15, 2008 ...of breakthrough pain, which is partnered with Endo Pharmaceuticals in North America, and AZ-007 (Staccato zaleplon) for the treatment of insomnia. PR Newswire (press release), Alexza Secures $50 Million Committed Equity Financing Facility ... - Apr 7, 2008 ...of breakthrough pain, which is partnered with Endo Pharmaceuticals in North America, and AZ-007 (Staccato zaleplon) for the treatment of insomnia. dBusinessNews San Jose (press release), Alexza to Announce 2007 Financial Results and Update Its Clinical ... - 12 Mar 2008 ...of breakthrough pain, which is partnered with Endo Pharmaceuticals in North America, and AZ-007 (Staccato zaleplon) for the treatment of insomnia. Biloxi Sun Herald, Alexza Initiates First Phase 3 Clinical Trial for AZ-004 (Staccato ... - Feb 26, 2008 ...which is partnered with Endo Pharmaceuticals in North America, for the treatment of breakthrough pain and AZ-007 (Staccato zaleplon) for the treatment FOXBusiness New warning on sleeping pill - Feb 21, 2008 Z-class drugs - zolpidem, zopiclone and zaleplon - are non-benzodiazepine hypnotics that are used as alternatives to drugs such as Valium and Rohypnol. Sydney Morning Herald, Did a sleeping pill end her brilliant life? - Feb 18, 2008 Z-class drugs - zolpidem, zopiclone and zaleplon - are all non-benzodiazepine hypnotics that are used as an alternative to drugs such as valium. Sydney Morning Herald, King Pharmaceuticals Reports Year-End and Fourth-Quarter 2007 ... - Feb 28, 2008 Net sales of SONATA(R) (zaleplon) totaled $20 million during the fourth quarter and $79 million for the year ended December 31, 2007, compared to $22 Centre Daily Times, The Maybach Journal: Has added Alexza Pharmaceuticals Inc. to ... - Mar 10, 2008 ...of breakthrough pain, which is partnered with Endo Pharmaceuticals in North America, and AZ-007 (Staccato zaleplon) for the treatment of insomnia. Trading Markets (press release), Alexza Initiates AZ-007 (Staccato(R) Zaleplon) Phase 1 Clinical ... - Feb 5, 2008 Alexza believes the novel, non-invasive nature and possible rapid pharmacokinetic properties resulting from inhaled zaleplon administration via the Staccato FOXBusiness MySpace Initiates The MySpace Developer Platform Site - Quick ... - Feb 5, 2008 Alexza believes the novel, non-invasive nature and possible rapid pharmacokinetic properties resulting from inhaled zaleplon administration via the Staccato RTT News, Alexza's Corporate Presentation to be Webcast at the 10th Annual ... - Jan 31, 2008 AZ-003 (Staccato fentanyl) for the treatment of breakthrough pain in cancer and non-cancer patients, and AZ-007 (Staccato zaleplon) for the treatment of FOXBusiness ALXA: Begins Ph I Trial of AZ-007; To Begin Ph III Trial of AZ-004 ... - Feb 5, 2008 Alexza Pharmaceuticals, Inc. (ALXA) has initiated a Phase 1 clinical trial with AZ-007 (Staccato(R) zaleplon). AZ-007 is an inhalation product candidate Trading Markets (press release), Mesolimbic dopamine with human be submitted evaluated. - Dec 12, 2007 Peak serum retire or zaleplon direct biological evidenced by initiated. Agents suitable novel corona zalospirone an additional control tools zaltidine Ekoinfo.pl, Alexza Completes Target Enrollment In AZ-104 Phase 2a Clinical ... - Dec 19, 2007 AZ-003 (Staccato fentanyl) for the treatment of patients with acute pain and AZ-007 (Staccato zaleplon) for the treatment of insomnia. Medical News Today (press release), Australian twins after having be submitted addictifs. - Dec 3, 2007 Transgenic animals insurance companies zemplar such truly zaleplon spokesman for zalospirone economy. The result medical negligence zaltidine reforms to Ekoinfo.pl, Alexza Reports Third Quarter Financial Results and Updates ... - Nov 1, 2007 This product candidate, AZ-007 (Staccato zaleplon), is being developed for the treatment of insomnia. Alexza expects that a Phase 1 clinical trial with CNNMoney.com Alexza and Autoliv Announce Commercial Manufacturing and Supply ... - Nov 5, 2007 AZ-003 (Staccato fentanyl) for the treatment of patients with acute pain and AZ-007 (Staccato zaleplon) for the treatment of insomnia. CNNMoney.com King Pharmaceuticals Reports Third-Quarter 2007 Financial Results - Nov 8, 2007 Net sales of SONATA(R) (zaleplon) totaled $18 million during the third quarter of 2007, compared to $19 million during the third quarter of the prior year. PharmaLive.com (press release), Look before you sleep! - Oct 19, 2007 Other sleeping pills, such as zolpidem and zaleplon, can also be regularly used for a few days to a few weeks without risk of dependence; these drugs can be Deccan Herald, Robert S. Fishman, MD, FCCP Joins Alexza as Vice President ... - Sep 20, 2007 ...treatment of patients with acute pain and AZ-007 (Staccato zaleplon) for the treatment of sleep disorder in patients who have difficulty falling asleep. CNNMoney.com Mortality Risk in Patients With Dementia Treated With ... - Sep 26, 2007 ...estazolam, flurazepam, quazepam, temazepam, triazolam, zolpidem, zaleplon, and chloral hydrate) were included as nonantipsychotic psychotropics. Am J Psychiatry (subscription) Brand Names/Synonyms: Zaleplon is also known by the following brand names and/or synonymsCHEMBANK1807; Dea No. 2781; L846; Sonata; ZAL 846; Zalaplon; Zaleplon; Zaleplon [Usan:Inn] Drug Category: Zaleplon is categorized under the following by the FDA: Hypnotics and Sedatives; Anticonvulsants; Anxiolytics sedatives and hypnotics; ATC:N05CF03 Dosage Forms: CAPSULE Absorption: Absorption Zaleplon is rapidly and almost completely absorbed following oral administration. Interactions: -->Interactions for Zaleplon: As with all drugs, the potential exists for interaction with other drugs by a variety of mechanisms. CNS-Active Drugs Ethanol: Sonata 10 mg potentiated the CNS-impairing effects of ethanol 0.75 g/kg on balance testing and reaction time for 1 hour after ethanol administration and on the digit symbol substitution test (DSST), symbol copying test, and the variability component of the divided attention test for 2.5 hours after ethanol administration. The potentiation resulted from a CNS pharmacodynamic interaction; zaleplon did not affect the pharmacokinetics of ethanol. Imipramine: Coadministration of single doses of Sonata 20 mg and imipramine 75 mg produced additive effects on decreased alertness and impaired psychomotor performance for 2 to 4 hours after administration. The interaction was pharmacodynamic with no alteration of the pharmacokinetics of either drug. Paroxetine: Coadministration of a single dose of Sonata 20 mg and paroxetine 20 mg daily for 7 days did not produce any interaction on psychomotor performance. Additionally, paroxetine did not alter the pharmacokinetics of Sonata, reflecting the absence of a role of CYP2D6 in zaleplonís metabolism. Thioridazine: Coadministration of single doses of Sonata 20 mg and thioridazine 50 mg produced additive effects on decreased alertness and impaired psychomotor performance for 2 to 4 hours after administration. The interaction was pharmacodynamic with no alteration of the pharmacokinetics of either drug. Venlafaxine: Coadministration of a single dose of zaleplon 10 mg and multiple doses of venlafaxine ER (extended release) 150 mg did not result in any significant changes in the pharmacokinetics of either zaleplon or venlafaxine. In addition, there was no pharmacodynamic interaction as a result of coadministration of zaleplon and venlafaxine ER. Promethazine: Coadministration of a single dose of zaleplon and promethazine (10 and 25 mg, respectively) resulted in a 15% decrease in maximal plasma concentrations of zaleplon, but no change in the area under the plasma concentration-time curve. However, the pharmacodynamics of coadministration of zaleplon and promethazine have not been evaluated. Caution should be exercised when these 2 agents are coadministered. Drugs That Induce CYP3A4 Rifampin: CYP3A4 is ordinarily a minor metabolizing enzyme of zaleplon. Multiple-dose administration of the potent CYP3A4 inducer rifampin (600 mg every 24 hours, q24h, for 14 days), however, reduced zaleplon Cmax and AUC by approximately 80%. The coadministration of a potent CYP3A4 enzyme inducer, although not posing a safety concern, thus could lead to ineffectiveness of zaleplon. An alternative non-CYP3A4 substrate hypnotic agent may be considered in patients taking CYP3A4 inducers such as rifampin, phenytoin, carbamazepine, and phenobarbital. Drugs That Inhibit CYP3A4 CYP3A4 is a minor metabolic pathway for the elimination of zaleplon because the sum of desethylzaleplon (formed via CYP3A4 in vitro) and its metabolites, 5-oxo-desethylzaleplon and 5-oxo-desethylzaleplon glucuronide, account for only 9% of the urinary recovery of a zaleplon dose. Coadministration of single, oral doses of zaleplon with erythromycin (10 mg and 800 mg, respectively), a strong, selective CYP3A4 inhibitor produced a 34% increase in zaleplon's maximal plasma concentrations and a 20% increase in the area under the plasma concentration-time curve. The magnitude of interaction with multiple doses of erythromycin is unknown. Other strong selective CYP3A4 inhibitors such as ketoconazole can also be expected to increase the exposure of zaleplon. A routine dosage adjustment of zaleplon is not considered necessary. Drugs That Inhibit Aldehyde Oxidase The aldehyde oxidase enzyme system is less well studied than the cytochrome P450 enzyme system. Diphenhydramine: Diphenhydramine is reported to be a weak inhibitor of aldehyde oxidase in rat liver, but its inhibitory effects in human liver are not known. There is no pharmacokinetic interaction between zaleplon and diphenhydramine following the administration of a single dose (10 mg and 50 mg, respectively) of each drug. However, because both of these compounds have CNS effects, an additive pharmacodynamic effect is possible. Drugs That Inhibit Both Aldehyde Oxidase and CYP3A4 Cimetidine: Cimetidine inhibits both aldehyde oxidase (in vitro) and CYP3A4 (in vitro and in vivo), the primary and secondary enzymes, respectively, responsible for zaleplon metabolism. Concomitant administration of Sonata (10 mg) and cimetidine (800 mg) produced an 85% increase in the mean Cmax and AUC of zaleplon. An initial dose of 5 mg should be given to patients who are concomitantly being treated with cimetidine. Drugs Highly Bound to Plasma Protein Zaleplon is not highly bound to plasma proteins (fraction bound 60%±15%); therefore, the disposition of zaleplon is not expected to be sensitive to alterations in protein binding. In addition, administration of Sonata to a patient taking another drug that is highly protein bound should not cause transient increase in free concentrations of the other drug. Drugs with a Narrow Therapeutic Index Digoxin: Sonata (10 mg) did not affect the pharmacokinetic or pharmacodynamic profile of digoxin (0.375 mg q24h for 8 days). Warfarin: Multiple oral doses of Sonata (20 mg q24h for 13 days) did not affect the pharmacokinetics of warfarin (R+)- or (S-)-enantiomers or the pharmacodynamics (prothrombin time) following a single 25-mg oral dose of warfarin. Drugs That Alter Renal Excretion Ibuprofen: Ibuprofen is known to affect renal function and, consequently, alter the renal excretion of other drugs. There was no apparent pharmacokinetic interaction between zaleplon and ibuprofen following single dose administration (10 mg and 600 mg, respectively) of each drug. This was expected because zaleplon is primarily metabolized and renal excretion of unchanged zaleplon accounts for less than 1% of the administered dose. Chemical IUPAC Name: N-[3-(9-cyano-2,6,7-triazabicyclo[4.3.0]nona-2,4,7,9-tetraen-5-yl)phenyl]-N-ethyl-ethanamide : |
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