Author: James Anderson

Ambien Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

As you get older, your sleep pattern may naturally change and your sleep may be interrupted several times during the night. Consult your doctor or pharmacist for ways to improve your sleep without medication, such as avoiding caffeine and alcohol close to bedtime, avoiding daytime naps, and going to bed at the same time each night. During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug late in the last 3 months of pregnancy may develop unusual sleepiness, trouble breathing, unusual limpness, or withdrawal symptoms. Get medical help right away if you notice any unusual symptoms in your newborn. 2.3% of those who had abused the drug in the past year also had at least one visit to the emergency room relating to the use of illicit drugs within that same year.

It is important to emphasize that,although the events reported did occur during treatment with AMBIEN, they werenot necessarily caused by it. AMBIEN (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. AMBIEN has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies]. A single-dose interaction study with zolpidem tartrate 10 mg and itraconazole 200 mg at steady-state levels in male volunteers resulted in a 34% increase in AUC0-∞ of zolpidem tartrate. There were no pharmacodynamic effects of zolpidem detected on subjective drowsiness, postural sway, or psychomotor performance.

The table includes only adverse events occurring at anincidence of at least 1% for zolpidem patients. Controlled studies in adults utilizing objective measures of memory yielded no consistent evidence of next-day memory impairment following the administration of AMBIEN. There was also subjective evidence from adverse event data for anterograde amnesia occurring in association with the administration of AMBIEN, predominantly at doses above 10 mg. Coadministration of zolpidem with other CNS depressants increases the risk of CNS depression [see WARNINGS AND PRECAUTIONS]. Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs. Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness.

Before taking this medicine

Dr. Ahmed Zayed has degrees in Medicine and Surgery and is a graduate of The University of Alexandria. Dr. Ahmed Zayed has a passion for writing medical and healthcare articles and focuses on providing engaging and trustworthy information to readers. After successful graduation from Boston University, MA, Sharon gained a Master’s degree in Public Health. Since then, Sharon devoted herself entirely to the medical niche.

There have been reports of withdrawal signs and symptomsfollowing the rapid dose decrease or abrupt discontinuation of zolpidem.Monitor patients for tolerance, abuse, and dependence [see Drug Abuse And Dependence]. Abnormal thinking and behavior changes have been reportedin patients treated with sedative/hypnotics, including AMBIEN. Some of thesechanges included decreased inhibition (e.g., aggressiveness and extroversionthat seemed out of character), bizarre behavior, agitation anddepersonalization. Patients with mild to moderate hepatic impairment do not clear the drug as rapidly as normal subjects. The recommended dose of AMBIEN in these patients is 5 mg once daily immediately before bedtime.

Safety andeffectiveness of zolpidem in pediatric patients below the age of 18 years havenot been established. Published data from observational studies, birthregistries, and case reports on the use of zolpidem during pregnancy do notreport a clear association with zolpidem and major birth defects. The estimated background risk of major birth defects andmiscarriage for the indicated populations are unknown.

Do not start, stop, or change the dosage of any medicines without your doctor’s approval. Next-day residual effects of AMBIEN were evaluated in seven studies involving normal subjects. Studies of AMBIEN in non-elderly patients with insomnia did not detect evidence of next-day residual effects using the DSST, the Multiple Sleep Latency Test (MSLT), and patient ratings of alertness. Cases of angioedema involving the tongue, glottis orlarynx have been reported in patients after taking the first or subsequentdoses of sedative-hypnotics, including zolpidem.

Call your doctor if you still have worsened insomnia for the first few nights after you stop taking this medicine. Read all patient information, medication guides, and instruction sheets provided to you. The immediate-release tablet is used to help you fall asleep when you first go to bed. The extended-release form, Ambien CR, which has a first layer that dissolves quickly to help you fall asleep, and a second layer that dissolves slowly to help you stay asleep. Ask your healthcare provider or pharmacist for more information. Some compounds known to inhibit CYP3A may increase exposure to zolpidem.

Tell patients to discontinue AMBIEN and notify theirhealthcare provider immediately if they develop any of these symptoms [see BOXEDWARNING, WARNINGS AND PRECAUTIONS]. Older adults may be more sensitive to the side effects of this drug, especially dizziness, confusion, unsteadiness, and excessive drowsiness. Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake (“sleep-driving”). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. This problem can be dangerous (possibly fatal) to you or to others.

Description for Ambien

After multiple doses of zolpidem tartrate and fluoxetinean increase in the zolpidem half-life (17%) was observed. There was no evidenceof an additive effect in psychomotor performance [see CLINICAL PHARMACOLOGY]. The following table was derived from results of 11placebo-controlled short-term U.S. efficacy trials involving zolpidem in dosesranging from 1.25 to 20 mg.

1. A study involving cimetidine/zolpidem tartrate and ranitidine/zolpidem tartrate combinations revealed no effect of either drug on the pharmacokinetics or pharmacodynamics of zolpidem.
2. Coadministration with other CNS depressants (e.g.,benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases therisk of CNS depression [see DRUG INTERACTIONS].
3. Zolpidem tartrate addiction tends to develop in those who do not follow the instructions for the use of the drug or extend the duration of use beyond what was declared by their doctor.

The next morning, the person has no idea of what went on the night before. Even though Ambien is not as habit-forming as benzodiazepines, it is still addictive. Ambien is also a lot shorter-acting than most benzodiazepines, although some side effects may stick around. Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

Drug information

Avoid taking Ambien during travel, such as to sleep on an airplane. You may be awakened before the effects of the medicine have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking Ambien. Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.

As a result, many people with depression take sedatives such as Ambien. Although Ambien belongs to a different class of medicines than older drugs historically prescribed for sleep (such as benzodiazepines), it works similarly. So maybe it’s no surprise for you to hear that more than 10 million prescriptions are written for Ambien (zolpidem) or Ambien CR every year. Ambien is a sedative, also called a hypnotic, that is used to treat insomnia.

Since zolpidem works quickly, take it right before you get into bed. Do not take it with or after a meal because it will not work as quickly. If you are taking the capsule form of this medication, swallow whole.