ZALEPLON capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

INN (International Name):

ZALEPLON

Composition:

ZALEPLON 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zaleplon capsules are indicated for the short-term treatment of insomnia. Zaleplon capsules have 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. Zaleplon is contraindicated in patients: - who have experienced complex sleep behaviors after taking zaleplon (see WARNINGS ) - with hypersensitivity to zaleplon or any excipients in the formulation (see PRECAUTIONS ) 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 ot

Product summary:

Zaleplon capsules USP 5 mg are available as hard gelatin capsules with light blue cap and light blue body imprinted with "U" on cap and "131" on the body in black ink along the horizontal axis. NDC: 71335-0236-1: 30 Capsules in a BOTTLE NDC: 71335-0236-2: 60 Capsules in a BOTTLE NDC: 71335-0236-3: 90 Capsules in a BOTTLE NDC: 71335-0236-4: 20 Capsules in a BOTTLE NDC: 71335-0236-5: 28 Capsules in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ZALEPLON- ZALEPLON CAPSULE
Bryant Ranch Prepack
----------
MEDICATION GUIDE
Zaleplon Capsules USP C-IV
(zal' e plon)
Read this Medication Guide before you start taking zaleplon capsules
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 capsules when
you start taking it and at regular checkups.
What is the most important information I should know about zaleplon
capsules?
Zaleplon capsules may cause serious side effects including complex
sleep behaviors that may cause
serious injury and death.. After taking zaleplon capsules, 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 capsules 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 capsules exactly as prescribed
•
Do not take more zaleplon capsules than prescribed.
•
Take zaleplon capsules right before you get in bed, not sooner.
2. Do not take zaleplon capsules 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 capsules
•
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 capsules with your
other medicines
•
cannot get a full night's sleep
3. Stop taking zaleplon capsules and call your doctor right away if
you find out that you have done any of
the above activities after taking zaleplon capsules.
What are zaleplon capsules?
Zaleplon ca

Summary of Product characteristics

ZALEPLON- ZALEPLON CAPSULE
BRYANT RANCH PREPACK
----------
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
Zaleplon 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 contain zaleplon as the active ingredient.
Inactive ingredients
consist of microcrystalline cellulose, pregelatinized starch,
colloidal silicon dioxide,
sodium lauryl sulfate, magnesium stearate, lactose, gelatin, titanium
dioxide, FD&C blue
#1, FD&C red #40 and black iron oxide. The 5 mg capsules also contain
FD&C yellow
#5.
17
15
5
Meets USP Dissolution Test 2.
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 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.
Other nonclinical studies have also shown