DCSIMG
AMBIEN® CR (zolpidem tartrate) & Elderly Patients

Adverse Reactions in Elderly Patients

Body System/Adverse Event AMBIEN CR 6.25 mg
(n=99)
Placebo
(n=106)

Infections and Infestations

Nasopharyngitis 6 4
Lower respiratory tract infection 1 0
Otitis externa 1 0
Upper respiratory tract infection 1 0

Psychiatric Disorders

Anxiety 3 2
Psychomotor retardation 2 0
Apathy 1 0
Depressed Mood 1 0

Nervous System Disorders

Headache 14 11
Dizziness 8 3
Somnolence 6 5
Burning sensation 1 0
Dizziness postural 1 0
Memory disorders* 1 0
Muscle contractions involuntary 1 0
Paraesthesia 1 0
Tremor 1 0

Cardiac Disorders

Palpitations 2 0

Respiratory, Thoracic and Mediastinal Disorders

Dry throat 1 0

Gastrointestinal Disorders

Flatulence 1 0
Vomiting 1 0

Skin and Subcutaneous Tissue Disorders

Rash 1 0
Urticaria 1 0

Musculoskeletal and Connective Tissue Disorders

Arthralgia 2 0
Muscle cramp 2 1
Neck pain 2 0

Renal and Urinary Disorders

Dysuria 1 0

Reproductive System and Breast Disorders

Vulvovaginal dryness 1 0

General Disorders and Administration Site Conditions

Influenza-like illness 1 0
Pyrexia 1 0

Injury, Poisoning and Procedural Complications

Neck injury 1 0

*Memory disorders include memory impairment, amnesia, and anterograde amnesia.

Next: Residual Effects

pagedivide

* Maximum benefit is $240 off, up to $20 off each prescription (up to 12 prescriptions), depending on your out-of-pocket costs. Not valid for patients participating in Medicare, Medicaid, government (public insurance) programs, or any private payor in the state of Massachusetts and where prohibited by law.

AMBIEN CR is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

IMPORTANT SAFETY INFORMATION

In elderly or debilitated patients, or patients with hepatic insufficiency, the recommended dose is 6.25 mg and patients should be closely monitored. Due to its rapid onset of action, patients should take AMBIEN CR right before going to bed and when ready for sleep. Patients should not take AMBIEN CR unless they are prepared to get a full night’s sleep (7 to 8 hours) to avoid residual effects. Until they know how it will affect their physical or mental performance upon awakening, patients should not drive or operate hazardous machinery after taking AMBIEN CR or any other sleep medication. Complex behaviors such as somnambulism, including driving or eating while not fully awake, with amnesia for the event, as well as abnormal behaviors such as being more outgoing or aggressive than normal, confusion, agitation, and hallucinations may occur. AMBIEN CR should not be taken with alcohol as it may increase these abnormal behaviors. Discontinuation of AMBIEN CR should be strongly considered for patients reporting such complex behaviors. Angioedema may occur in patients taking AMBIEN CR and in rare cases may be fatal. Patients who develop angioedema should not be rechallenged. In primarily depressed patients, worsening of depression, including risk of suicidal thoughts or actions, including completed suicides, have been reported. The most commonly observed adverse effects in controlled clinical trials were headache, somnolence, and dizziness. Because individuals with a history of addiction or substance abuse are at increased risk of habituation and dependence, they should be under careful surveillance when receiving AMBIEN CR or any other hypnotic. AMBIEN CR is a Schedule IV controlled substance.

Please refer to the full prescribing information.