ZALEPLON- zaleplon capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (International Name):

ZALEPLON

Composition:

ZALEPLON 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Hypersensitivity to zaleplon or any excipients in the formulation (see also 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 other psychoactive substances. Physical dependence is a state of adaption that is manifested by a specific withdrawal syndrome that can be produced by abrupt ces

Product summary:

Zaleplon capsules 10 mg are available as hard gelatin capsules with dark blue cap and dark blue body imprinted with "U" on cap and "132" on the body in black ink along the horizontal axis. Bottles of 30 NDC: 35356-656-30 Bottles of 60 NDC: 35356-656-60 Bottles of 90 NDC: 35356-656-90 STORAGE CONDITIONS Store at controlled room temperature, 20°C to 25°C (68°F to 77°F) [see USP]. Dispense in a light-resistant container as defined in the USP. Issue date: June 2008 PSEUSA041-00 ________________________________________________________________________________________________________________________________________________

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ZALEPLON- ZALEPLON CAPSULE
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
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MEDICATION GUIDE
Zaleplon Capsules C-IV
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?
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. The next morning, you may not remember that
you did anything during the
night. You have a higher chance for doing these activities if you
drink alcohol or take other medicines
that make you sleepy with Zaleplon.
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:
•
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. 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 trouble falling asleep from insomnia. Zaleplon does
not treat other

Summary of Product characteristics

ZALEPLON- ZALEPLON CAPSULE
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
----------
ZALEPLON CAPSULES
CIV
RX ONLY
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 empirical
formula is C
H N O, and its molecular weight is 305.34. The structural formula is
shown below.
ZALEPLON
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 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. Zaleplon 5mg capsules also contain FD&C yellow #5.
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 that zaleplon binds
selectively to the brain omega-1 receptor
situated on the alpha subunit of the GABA /chloride ion channel
receptor complex and potentiates t-
butyl-bicyclophosphorothionate (TBPS) binding. Studies of binding of
zaleplon to recombinant GABA
receptors (α β γ [omega-1] and α β γ [omega-2]) have shown that
zaleplon has a low affinity for
these receptors, with prefe