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Zaleplon Capsules CIV | ZALEPLON [Physicians Total Care, Inc.] | BioPortfolio

12:49 EST 27th January 2019 | BioPortfolio

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Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zaleplon. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with zaleplon should not be rechallenged with the drug.

  Table 1  Incidence (%) of Treatment-Emergent Adverse Events in Long-Term (28 and 35 Nights) Placebo-Controlled Clinical Trials of Zaleplon1
   Body System
      Preferred Term
Placebo

(n = 344)
Zaleplon
5 mg or 10 mg
(n = 569)
Zaleplon
20 mg
(n = 297)
1: Events for which the incidence for zaleplon 20 mg-treated patients was at least 1% and greater than the incidence among placebo-treated patients. Incidence greater than 1% has been rounded to the nearest whole number.
   Body as a whole
 
 
 
      Abdominal pain
3
6
6
      Asthenia
5
5
7
      Headache
35
30
42
      Malaise
<1
<1
2
      Photosensitivity reaction
<1
<1
1
   Digestive system
      Anorexia
<1
<1
2
      Colitis
0
0
1
      Nausea
7
6
8
   Metabolic and nutritional
      Peripheral edema
<1
<1
1
   Nervous system
 
 
 
      Amnesia
1
2
4
      Confusion
<1
<1
1
      Depersonalization
<1
<1
2
      Dizziness
7
7
9
      Hallucinations
<1
<1
1
      Hypertonia
<1
1
1
      Hypesthesia
<1
<1
2
      Paresthesia
1
3
3
      Somnolence
4
5
6
      Tremor
1
2
2
      Vertigo
<1
<1
1
   Respiratory system
      Epistaxis
<1
<1
1
   Special senses
      Abnormal vision
<1
<1
2
      Ear pain
0
<1
1
      Eye pain
2
4
3
      Hyperacusis
<1
1
2
      Parosmia
<1
<1
2
   Urogenital system
      Dysmenorrhea
2
3
4

Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances.

Physical dependence is a state of adaption that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time. Tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects.

Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact, sometimes causing side effects. Do not take zaleplon with other medicines that can make you sleepy.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.  

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using zaleplon.

These are not all the side effects of zaleplon. Ask your doctor or pharmacist for more information.

This Medication Guide summarizes the most important information about zaleplon. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about zaleplon that was written for healthcare professionals.

If you would like more information, contact the Aurobindo Pharma USA, Inc. Professional Information Services at 1-866-850-2876.

What are the ingredients in zaleplon capsules?

Active Ingredient: zaleplon

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Manufacturer

Physicians Total Care, Inc.

Active Ingredients

Source

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Clinical Trials [9 Associated Clinical Trials listed on BioPortfolio]

Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions

The objective of this study was the bioequivalence of a Roxane Laboratories' Zaleplon Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fed conditions using a single-dose,...

Pharmacokinetics of Staccato Zaleplon

The purpose of the study is to determine the safety, tolerability and pharmacokinetics of zaleplon delivered by the Staccato thermal aerosol system in healthy volunteers

Zaleplon in HIV Patients With Depression

In HIV positive patients with sleep onset insomnia and receiving pharmacologic treatment for comorbid depression, the proposed study aims to evaluate the impact of zaleplon on sleep measur...

Zaleplon 10 mg Capsules Under Non-Fasting Conditions

The objective of this study is to compare the relative bioavailability of zaleplon 10 mg capsules(manufactured and distributed by TEVA Pharmaceuticals USA) with that of SONATA® 10mg capsu...

Study of Sleep-maintenance Activity of 3 Doses of SKP-1041

SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is currently available as Sonata as well as several generic formulations. Sonata and its generics ind...

PubMed Articles [3 Associated PubMed Articles listed on BioPortfolio]

Solvent effects on the absorption and fluorescence spectra of Zaleplon: Determination of ground and excited state dipole moments.

Solvent effects on the absorption and fluorescence spectra of Zaleplon, a nonbenzodiazepine sedative/hypnotic drug that is mainly used for the short term treatment of insomnia, were investigated in 18...

Pharmacological agents for improving sleep quality at high altitude: a systematic review and meta-analysis of randomized controlled trials.

Several hypnotic agents commonly recommended for improving sleep at sea level are discouraged at high altitude. We aimed to evaluate the efficacy and safety of drugs prescribed for improving sleep qua...

An insight into Z-drugs abuse and dependence: an examination of reports to the European Medicines Agency (EMA) database of suspected Adverse Drug Reactions (ADR).

Although originally marketed as safe alternatives to the habit-forming benzodiazepines, growing numbers of zaleplon, zolpidem, and zopiclone ('Z-drugs') clinical concerns relating to their potential o...

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