ZALEPLON capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

ZALEPLON (UNII: S62U433RMH) (ZALEPLON - UNII:S62U433RMH)

Sẵn có từ:

Hikma Pharmaceuticals USA Inc.

INN (Tên quốc tế):

ZALEPLON

Thành phần:

ZALEPLON 5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Zaleplon is indicated for the short-term treatment of insomnia. Zaleplon has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY ) . It has not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment. Zalepon is contraindicated in patients: Zaleplon is classified as a Schedule IV controlled substance by federal regulation. 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: Two studies assessed the abuse liability of zaleplon at doses of 25 mg, 50 mg, and 75 mg in subjects with known histories of sedative drug abuse. The results of these studies indicate that zaleplon has an abuse potential similar to benzodiazepine and benzodiazepine-like hypnotics. Dependence: The potential for developing physical dependence on zaleplon and a subsequent withdrawal syndrome was assessed in controlled studies of 14-, 28-, and 35-night durations and in open-label studies of 6- and 12-month durations by examining for the emergence of rebound insomnia following drug discontinuation. Some patients (mostly those treated with 20 mg) experienced a mild rebound insomnia on the first night following withdrawal that appeared to be resolved by the second night. The use of the Benzodiazepine Withdrawal Symptom Questionnaire and examination of any other withdrawal-emergent events did not detect any other evidence for a withdrawal syndrome following abrupt discontinuation of zaleplon therapy in pre-marketing studies. However, available data cannot provide a reliable estimate of the incidence of dependence during treatment at recommended doses of zaleplon. Other sedative/hypnotics have been associated with various signs and symptoms following abrupt discontinuation, ranging from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions. Seizures have been observed in two patients, one of which had a prior seizure, in clinical trials with zaleplon. Seizures and death have been seen following the withdrawal of zaleplon from animals at doses many times higher than those proposed for human use. Because individuals with a history of addiction to, or abuse of, drugs or alcohol are at risk of habituation and dependence, they should be under careful surveillance when receiving zaleplon or any other hypnotic. Tolerance: Possible tolerance to the hypnotic effects of zaleplon 10 mg and 20 mg was assessed by evaluating time to sleep onset for zaleplon compared with placebo in two 28-night placebo-controlled studies and latency to persistent sleep in one 35-night placebo-controlled study where tolerance was evaluated on nights 29 and 30. No development of tolerance to zaleplon was observed for time to sleep onset over 4 weeks.

Tóm tắt sản phẩm:

Zaleplon Capsules, USP 5 mg capsule is supplied as a light green opaque capsule with “54 656” printed in black ink on cap and body, containing a white to an off-white powder. NDC 0054-0084-25: Bottle of 100 Capsules 10 mg capsule is supplied as a green opaque capsule with “54 888” printed in black ink on cap and body, containing a white to an off-white powder. NDC 0054-0085-25: Bottle of 100 Capsules STORAGE CONDITIONS Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP/NF. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000505/01 Revised February 2023

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

ZALEPLON- ZALEPLON CAPSULE
West-Ward Pharmaceuticals Corp.
----------
MEDICATION GUIDE
Zaleplon Capsules USP CIV
(zal’ e plon)
Rx Only
Read this Medication Guide before you start taking zaleplon and each
time you get a refill. There may be
new information. This Medication Guide does not take the place of
talking to your doctor about your
medical condition or treatment. You and your doctor should talk about
zaleplon when you start taking it
and at regular checkups.
What is the most important information I should know about zaleplon?
Zaleplon may cause serious side effects including complex sleep
behaviors that may cause serious injury
and death. After taking zaleplon, you may get up out of bed while not
being fully awake and do an
activity that you do not know you are doing (complex sleep behaviors).
The next morning, you may not
remember that you did anything during the night. These activities may
occur with zaleplon whether or not
you drink alcohol or take other medicines that make you sleepy.
Reported activities include:
•
driving a car ("sleep-driving")
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Important:
1. Take zaleplon exactly as prescribed
•
Do not take more zaleplon than prescribed.
•
Take zaleplon right before you get in bed, not sooner.
2. Do not take zaleplon if you:
•
have ever experienced a complex sleep behavior (such as driving a car,
making and eating food,
talking on the phone or having sex while not fully awake) after taking
zaleplon
•
drink alcohol
•
take other medicines that can make you sleepy. Talk to your doctor
about all of your medicines.
Your doctor will tell you if you can take zaleplon with your other
medicines
•
cannot get a full night’s sleep
3. Stop taking zaleplon and call your doctor right away if you find
out that you have done any of the
above activities after taking zaleplon.
What is zaleplon?
Zaleplon is a sedative/hypnotic (sleep) medicine. Zaleplon is used in
adults for the short-term treatment of
the symptom of tr

Đặc tính sản phẩm

ZALEPLON- ZALEPLON CAPSULE
WEST-WARD PHARMACEUTICALS CORP.
----------
ZALEPLON CAPSULES USP CIV
WARNING: COMPLEX SLEEP BEHAVIORS
COMPLEX SLEEP BEHAVIORS INCLUDING SLEEP-WALKING, SLEEP-DRIVING, AND
ENGAGING IN OTHER
ACTIVITIES WHILE NOT FULLY AWAKE MAY OCCUR FOLLOWING USE OF ZALEPLON.
SOME OF THESE EVENTS
MAY RESULT IN SERIOUS INJURIES, INCLUDING DEATH. DISCONTINUE ZALEPLON
IMMEDIATELY IF A PATIENT
EXPERIENCES A COMPLEX SLEEP BEHAVIOR _(SEE CONTRAINDICATIONS AND
COMPLEX SLEEP_
_BEHAVIORS UNDER WARNINGS)_.
DESCRIPTION
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 molecular
formula is C
H N O, and its molecular weight is 305.34. The structural formula is
shown below.
Zaleplon USP is a white to off-white powder that is practically
insoluble in water and sparingly soluble
in alcohol or propylene glycol. Its partition coefficient in
octanol/water is constant (log PC = 1.23) over
the pH range of 1 to 7.
Zaleplon Capsules USP are available for oral administration containing
either 5 mg or 10 mg of
zaleplon. Each capsule contains the following inactive ingredients:
colloidal silicon dioxide, lactose
(anhydrous), magnesium stearate, microcrystalline cellulose,
pregelatinized starch and sodium lauryl
sulfate. Each capsule shell contains: D&C Yellow #10, FD&C Blue #1,
FD&C Yellow #6 (10 mg
capsule shell only), gelatin, monogramming ink and titanium dioxide.
The monogramming ink contains:
ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl
alcohol, propylene glycol and
shellac glaze.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS AND MECHANISM OF ACTION
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 (GABA-BZ) receptor complex. Subunit modulation of the
GABA-BZ receptor chloride
17
15
5
channel macromolecular complex is hypo