ZOLPIMIST- zolpidem tartrate spray, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)

Available from:

Magna Pharmaceuticals, Inc.

INN (International Name):

Zolpidem Tartrate

Composition:

Zolpidem Tartrate 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zolpimist (zolpidem tartrate) Oral Spray (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)] . The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpimist (zolpidem tartrate) Oral Spray is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema [see Warnings and Precautions (5.3)]. Pregnancy Category C There are no adequate and well-controlled studies of Zolpimist (zolpidem tartrate) Oral Spray in pregnant women. Studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used

Product summary:

Zolpimist (zolpidem tartrate) Oral Spray is available in a child-resistant container, which secures a bottle filled with either 4.5 mL (4.8 g) or 7.7 mL (8.2g). Each container includes a child-resistant cap and base with a metered-dose pump assembly in a bottle with a clear cap. One and two actuations of Zolpimist (zolpidem tartrate) Oral Spray deliver 5 and 10 mg of zolpidem tartrate, respectively. There are 30 metered actuations in the 4.5 mL-filled container and 60 metered actuations, after 5 initial priming actuations. Zolpimist (zolpidem tartrate) Oral Spray is supplied as: NDC Number 58407-0510-30 and, Size Carton includes a child-resistant container with 4.5 mL (4.8 g) of product formulation; 30 metered actuations per container. NDC Number 58407-0510-60 Size Carton includes a child-resistant container with 7.7 mL (8.2 g) of product formulation; 60 metered actuations per container. Store upright at 25 °C (77 °F) with excursions permitted to 15-30 °C (59-86 °F) ( USP Controlled Room Temperature). Do not freeze. Avoid prolonged product exposure to temperatures above 30 °C (86 °F). The child-resistant container should be discarded when the labeled number of actuations (30 or 60 sprays) have been used. KEEP OUT OF REACH OF CHILDREN.

Authorization status:

New Drug Application

Patient Information leaflet

ZOLPIMIST- ZOLPIDEM TARTRATE SPRAY, METERED
Magna Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Zolpimist (zolpidem tartrate) Oral Spray (Zol-pi-mist) [zolpidem
tartrate oral spray (CIV)]
Read the Medication Guide that comes with Zolpimist (zolpidem
tartrate) Oral Spray before you start taking
it and each time you get a refill. There may be new information. This
Medication Guide does not take the
place of talking to your healthcare provider about your medical
condition or treatment.
What is the most important information I should know about Zolpimist
(zolpidem tartrate) Oral Spray?
•
Do not take more Zolpimist (zolpidem tartrate) Oral Spray than
prescribed.
•
Do not take Zolpimist (zolpidem tartrate) Oral Spray unless you are
able to stay in bed a full night (7
to 8 hours) before you must be active again.
Take Zolpimist (zolpidem tartrate) Oral Spray right before you get in
bed, not sooner. Zolpimist (zolpidem
tartrate) Oral Spray may cause serious side effects including:
•
After taking Zolpimist (zolpidem tartrate) Oral Spray, 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
Zolpimist (zolpidem tartrate)
Oral Spray. Reported activities include:
•
driving a car ("sleep-driving")
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Call your healthcare provider right away if you find out that you have
done any of the above activities after
taking Zolpimist (zolpidem tartrate) Oral Spray. Do not take Zolpimist
(zolpidem tartrate) Oral Spray if you:
•
drank alcohol that evening or before bed
•
took another medicine to help you sleep
What is Zolpimist (zolpidem tartrate) Oral Spray?
Zolpimist (zolpidem tartrate) Oral Spray is a sedative-hypnotic
(sleep) medicine. Zolpimist (zolpidem
tartrate) Oral Spray is used i

Summary of Product characteristics

ZOLPIMIST- ZOLPIDEM TARTRATE SPRAY, METERED
MAGNA PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLPIMIST (ZOLPIDEM TARTRATE) ORAL SPRAY
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLPIMIST
(ZOLPIDEM TARTRATE) ORAL SPRAY.
ZOLPIMIST (ZOLPIDEM TARTRATE) ORAL SPRAY (C-IV)
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Dosage and Administration ( 2)
5/2013
Dosage and Administration, Dosage in Adults ( 2.1)
5/2013
Warnings and Precautions ( 5)
5/2013
INDICATIONS AND USAGE
Zolpimist (zolpidem tartrate) Oral Spray, a gamma-aminobutyric acid
(GABA) A agonist, is indicated for the short-term
treatment of insomnia characterized by difficulties with sleep
initiation. Zolpidem tartrate has been shown to decrease
sleep latency for up to 35 days in controlled clinical studies. ( 1)
DOSAGE AND ADMINISTRATION
Use the lowest dose effective for the patient. ( 2.1)
Recommended initial dose is 5 mg for women and 5 or 10 mg for men,
immediately before bedtime with at least 7-8
hours remaining before the planned time of awakening. ( 2.1)
Geriatric patients and patients with hepatic impairment: Recommended
dose is 5 mg for men and women. ( 2.2)
Lower doses of CNS depressants may be necessary when taken
concomitantly with Zolpimist (zolpidem tartrate) Oral
Spray. ( 2.3)
The effect of zolpidem Tartrate oral spray (Zolpimist) may be slowed
if taken with or immediately after a meal. ( 2.4)
DOSAGE FORMS AND STRENGTHS
Each metered actuation (one spray) of Zolpimist (zolpidem tartrate)
Oral Spray delivers 5 mg of zolpidem tartrate in 100
uL. After an initial priming of 5 actuations, there are 30 or 60
metered actuations in each child-resistant container. The total
number of available doses is dependent on the number of actuations per
dose (1 or 2 actuations) and the frequency of
priming. ( 3)
CONTRAINDICATIONS
Known hypersensitivity to zolpidem. ( 4)
WARNINGS AND PRECAUTIONS
CNS depressant effects: Impairs alertness and motor coordin