FDA Recently Published Data about Ambien (zolpidem tartrate) Tablets

FDA, Aug 14, 2008

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Abnormal thinking and behavioral changes
Special populations Use in patients with concomitant illness

ADVERSE REACTIONS

Clinical trials experience

Adverse event incidence across the entire preapproval database
Body as a whole
Fatigue
Central and peripheral nervous system
headache
anxiety
nervousness
Gastrointestinal system
dyspepsia
nausea
anorexia
vomiting
Immunologic system
Infection (infrequent)
Musculoskeletal system
Frequent
arthralgia
myalgia
Respiratory system
upper respiratory infection (frequent)
rhinitis
Urogenital system
urinary tract infection (frequent)

DRUG INTERACTIONS

-Drugs that affect drug metabolism via cytochrome P450
-Drug-laboratory test interactions

USE IN SPECIFIC POPULATIONS

Pregnancy
Nursing mothers
Pediatric use
Geriatric use

PATIENT COUNSELING INFORMATION

Severe anaphylactic and anaphylactoid reactions
Sleep-driving and other complex behaviors
Administration instructions

MEDICATION GUIDE

CONTRAINDICATIONS

...Observed reactions include anaphylaxis and angioedema.

WARNINGS AND PRECAUTIONS

Abnormal thinking and behavioral changes

Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported with sedative-hypnotics, including zolpidem...

Special populations: Use in patients with concomitant illness

...Since sedative/hypnotics have the capacity to depress respiratory drive, precautions should be taken if Ambien is prescribed to patients with compromised respiratory function...

...Ambien should be used with caution in patients with sleep apnea syndrome or myasthenia gravis

Read more at:

fda.gov/medwatch/SAFETY/2008/may08_quickview.htm