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AMBIEN® CR (zolpidem tartrate) Side Effects Next Day
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AMBIEN CR (Zolpidem Tartrate Extended Release) Sleep Aid

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Residual Effects

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Next-day residual effects 4

In five clinical studies [three controlled studies in adults (18-64 years of age) administered AMBIEN CR 12.5 mg and two controlled studies in the elderly (≥ 65 years of age) administered AMBIEN CR 6.25 mg or 12.5 mg], the effects of AMBIEN CR on vigilance, memory, or motor function were assessed using neurocognitive tests.

In these studies, no significant decrease in performance was observed eight hours after a nighttime dose. In addition, no evidence of next-day residual effects was detected with AMBIEN CR 12.5 mg and 6.25 mg using self-ratings of sedation.

During the 3-week studies, next-day somnolence was reported by 15% of the adult patients who received 12.5 mg AMBIEN CR versus 2% of the placebo group; next-day somnolence was reported by 6% of the elderly patients who received 6.25 mg
AMBIEN CR versus 5% of the placebo group. See Adverse Reactions.

In a 6-month study, the overall incidence of next-day somnolence was 5.7% in the AMBIEN CR group as compared to 2% in the placebo group.

AMBIEN CR rebound effects 4

Rebound insomnia, defined as a dose-dependent worsening in sleep parameters (latency, sleep efficiency, and number of awakenings) compared with baseline following discontinuation of treatment, is observed with short- and intermediate-acting hypnotics.

In the two 3-week placebo-controlled studies in patients with primary insomnia, a rebound effect was only observed on the first night after abrupt discontinuation of AMBIEN CR. On the second night, there was no worsening compared to baseline in the AMBIEN CR group.

In a 6-month placebo-controlled study in which AMBIEN CR was taken as needed (3 to 7 nights per week), within the first month a rebound effect was observed for Total Sleep Time (not for WASO) during the first night off medication. After this first month period, no further rebound insomnia was observed. After final treatment discontinuation no rebound was observed.

Next: AMBIEN CR Drug Interactions

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* 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.