Zaleplon Capsules CIV
DESCRIPTION
CLINICAL PHARMACOLOGY
Pharmacodynamics and Mechanism of Action
Pharmacokinetics
Absorption
Distribution
Metabolism
Elimination
Effect of Food
Special Populations
Drug-Drug Interactions
Clinical Trials
Controlled Trials Supporting Effectiveness
Studies Pertinent to Safety Concerns for Sedative/Hypnotic Drugs
INDICATIONS AND USAGE
CONTRAINDICATIONS
WARNINGS
Abnormal Thinking and Behavioral Changes
Severe anaphylactic and anaphylactoid reactions
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.
PRECAUTIONS
General
Timing of Drug Administration
Use in the elderly and/or debilitated patients
Use in patients with concomitant illness
Use in patients with depression
Information for Patients
SPECIAL CONCERNS “Sleep-Driving” and other complex behaviors
Laboratory Tests
Drug Interactions
CNS-Active Drugs
Drugs That Induce CYP3A4
Drugs That Inhibit CYP3A4
Drugs That Inhibit Aldehyde Oxidase
Drugs That Inhibit Both Aldehyde Oxidase and CYP3A4
Drugs Highly Bound to Plasma Protein
Drugs with a Narrow Therapeutic Index
Drugs That Alter Renal Excretion
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
Mutagenesis
Impairment of Fertility
Pregnancy
Labor and Delivery
Nursing Mothers
Pediatric Use
Geriatric Use
ADVERSE REACTIONS
Adverse Findings Observed in Short-Term, Placebo-Controlled Trials
Adverse Events Associated With Discontinuation of Treatment
Adverse Events Occurring at an Incidence of 1% or More Among Zaleplon 20 mg-Treated Patients
| 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 |
Other Adverse Events Observed During the Premarketing Evaluation of Zaleplon
Postmarketing Reports
DRUG ABUSE AND DEPENDENCE
Controlled Substance Class
Abuse, Dependence, and Tolerance
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.
Abuse
Dependence
Tolerance
OVERDOSAGE
Signs and Symptoms
Recommended Treatment
Poison Control Center
DOSAGE AND ADMINISTRATION
Special Populations
Hepatic insufficiency
Renal insufficiency
HOW SUPPLIED
MEDICATION GUIDE
- driving a car ("sleep-driving")
- making and eating food
- talking on the phone
- having sex
- sleep-walking
Who should not take zaleplon?
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
- have a history of depression, mental illness, or suicidal thoughts
- have a history of drug or alcohol abuse or addiction
- have kidney or liver disease
- have a lung disease or breathing problems
- are pregnant, planning to become pregnant, or breastfeeding