- Ambien Detection Time – How Long Does Ambien Stay In Your System?
- How Long Does Ambien Stay In The Body?
- Factors That Influence How Long Ambien Stays In The System
- How Does Ambien Work?
- Getting Help For Ambien Abuse And Addiction
- Insane Stories Of People On Ambien That’ll Brighten Your Day
- Ask the doctor: Is it okay to keep on taking Ambien for my sleeping problems?
- Complex Sleep Behaviors
- CNS-Depressant Effects And Next-Day Impairment
- Need To Evaluate For Comorbid Diagnoses
- Severe Anaphylactic And Anaphylactoid Reactions
- Abnormal Thinking And Behavioral Changes
- Use In Patients With Depression
- Respiratory Depression
- Precipitation Of Hepatic Encephalopathy
- Withdrawal Effects
- Patient Counseling Information
- Nonclinical Toxicology
- Carcinogenesis, Mutagenesis, Impairment Of Fertility
- Use In Specific Populations
- Pediatric Use
- Geriatric Use
- Gender Difference In Pharmacokinetics
- Hepatic Impairment
- What is Zolpidem (Ambien)?
- Side effects
- Middle-of-the-night ingestion
- Additional Resources:
- SIDE EFFECTS
- Clinical Trials Experience
- Postmarketing Experience
- Related posts:
Ambien Detection Time – How Long Does Ambien Stay In Your System?
Published on August 12, 2019
Ambien is a prescription medication used to help individuals overcome insomnia. This drug is very fast-acting, so it typically only stays in a person’s system for 24 to 48 hours. However, several factors influence how long Ambien is detectable in a person’s body, including an individual’s age, weight, and history of taking the drug.
Table of Contents
Zolpidem, which often goes by the brand name Ambien, is a medication most commonly prescribed to treat insomnia. This drug is known as a sedative/hypnotic and is highly effective at helping individuals fall sleep. It comes in both immediate- and extended-release forms, with immediate-release being used for people who struggle to fall asleep and extended-release used for individuals who cannot stay asleep.
Ambien can quickly become habit-forming, and many doctors will not prescribe this drug for longer than two weeks at a time. People who use this medication on a regular basis or in higher doses may be at risk of developing a dependence and addiction to zolpidem. This can result in withdrawal symptoms when the drug is suddenly stopped.
Addiction Campuses has several treatment program options that can help a person safely withdraw from Ambien as well as receive treatment to overcome addiction to this drug. If you are addicted to or dependent on zolpidem, seeking help is the best decision you can make.
How Long Does Ambien Stay In The Body?
Ambien begins working quickly after taking it. As a fast-acting drug, this also means that the medication does not stay in the system for very long, either. People usually begin to feel the effects of Ambien within 30 minutes, with peak effects being felt 1.5 to two hours after ingesting the drug.
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Because of its quick onset, Ambien has a relatively short half-life of around three hours. This means that most people have eliminated at least half of the drug by this time. Due to its short half-life, zolpidem is typically only detectable in the urine for 24 to 48 hours after the last dose is taken.
Urine tests are the most common testing method used to detect drugs like Ambien in the system. However, other tests may be used, as well.
The following are the drug tests that can detect Ambien and the lengths of time each can detect this drug in a person’s system:
- Blood — A blood test can typically detect Ambien in the system for up to 20 hours after the last dose.
- Hair — A hair follicle test may be able to detect Ambien for up to five weeks after the last use.
- Saliva — While uncommon, saliva tests can also be used to determine if Ambien is in the system. A saliva test may be able to trace Ambien as soon as 15 minutes after taking the drug and for up to eight hours after taking zolpidem.
These detection times are general estimates and will vary from person to person. Several factors can influence how long Ambien is detectable in an individual’s body.
Factors That Influence How Long Ambien Stays In The System
A number of things can affect the detection time of Ambien in a person’s system. Everyone will metabolize drugs at a different rate, which will ultimately determine how long a substance will stay in the body.
The following factors can influence how long zolpidem can be detected in the system:
- fluid and food consumption
- kidney and liver function and health
- how much Ambien a person has taken
- how frequently a person has used Ambien
People who are younger or have more body fat will typically metabolize Ambien more quickly than individuals who are older or who have a lower body fat percentage. Additionally, individuals who take more of the drug or who take Ambien for a longer period of time will likely have the substance in their system for a longer period of time.
How Does Ambien Work?
Ambien acts as a central nervous system (CNS) depressant by increasing the levels of gamma-aminobutyric acid (GABA) in the brain. This chemical is responsible for slowing activity in the brain to allow a person to fall asleep more easily. Individuals suffering from insomnia are often unable to calm the brain and body enough to fall asleep, so taking Ambien can help a person relax and increase feelings of calm.
Common side effects of zolpidem include drowsiness, lightheadedness, and dizziness. Ambien has also been known to cause sleepwalking, and some individuals may even participate in activities such as shopping or driving while in a sleep-like state. For these reasons, it’s important to take Ambien exactly as prescribed and to not take more than what is recommended.
Getting Help For Ambien Abuse And Addiction
Like many other CNS depressants, Ambien can be addictive if abused. If you or a loved one is struggling with an addiction to Ambien, there are many treatment options to consider to reclaim your life. Addiction Campuses has several treatment centers, all of which utilize proven treatment methods to help individuals overcome substance use disorders.
To learn more about how long Ambien stays in a person’s system, contact an Addiction Campuses’ treatment professional today.
Written by Addiction Campuses Editorial Team
Insane Stories Of People On Ambien That’ll Brighten Your Day
2.1.2016 By Jamal Stone
“Have you tripped on Ambien before?”
Asking friends, family, and strangers if they’ve experimented with Ambien is hardly an ideal ice breaker. The question was usually met with a confused silence–one of those pin-drop moments–or, on Facebook, an ice-cold “Seen” notification that would haunt me for hours. Hurriedly, I’d assure them that I wasn’t a narc, that I was simply gathering intel for an article. Unfortunately, my circles aren’t littered with insomniacs. “Nope,” my friend Dan* said, plainly, “never done it.”
But he was wrong. He had done it before; he just couldn’t remember. He’d encountered what some call the Ambien Walrus. The Walrus–large, lazy, flippered, and flippant–is the internet’s way of personifying the sleeping pill’s recreational effects, a mix of hypnosis, amnesia, and hallucinations.
The Ambien Walrus first scuttled into the public’s eye in 2007, thanks to an appearance in Drew Dee’s webcomic, Toothpaste for Dinner. Since then, the recurring character has become a fan favorite, especially among Ambien users and abusers, who can relate to the idiosyncratic demands that the crudely-drawn bag of blubber barks out. “Come with me on an adventure you’ll never remember,” the walrus beckons in a 2010 strip, urging the reader along with an outstretched flipper. “Call all your ex-girlfriends.” “Cut off all your hair.” Eventually, the Walrus’ fame outgrew the publication, becoming slang for any Ambien-fueled behavior: sleep-talking, sleep-eating, sleep-driving. Sleep time is no longer a passive act. Ambien has practically monopolized the hyphenated sleep market.
At his heart, the Ambien Walrus is a trader. He exchanges memories for mystery, thanks to the pill’s amnesic effect. “I think the Ambien Walrus stole all my brie last night,” one might say, keenly aware of the dried cheese matter commingled in their hair. You might as well trade in your rationale, too. If you’re still under Ambien’s grasp during waking hours, your oddball dream logic could still hold. Sleep-eaters on the drug have made an array of delectable late-night meals, such as “buttered cigarettes,” and “salt sandwiches”–just like Grandma used to make.
We snooped around Reddit’s Ambien subforum to see what high jinks the Walrus had been getting into lately–and boy, the confessional was packed. Under the hypnotic effect of Ambien, one user overnight shipped a crate of live, Maine lobsters to his ex-girlfriend. Another user ordered a $70 leg of ham from BBQ-enthusiast website, Pig of the Month, despite having been vegetarian for years. And a Navy officer woke up on Inspection Day to find that he’d MacGyvered a tar-black, treelike “superstructure” in the middle of the night–made out of cans, heated wax, Q-tips, and shoe polish. The list goes on, and on. The Walrus’s conquests are many.
Could sleep medication really have such odd ramifications? Perhaps the internet, a bastion of hyperbole, is overselling it. Stan*, an astrophysicist by day, pill-popper by night, corroborated Reddit’s wild tales. He broke Ambien’s effects down into subcategories: it’s “emotionally inspired, socially in love, and rationally inhibited.” “Go on Facebook and profess your love for someone you barely knew in high school,” he suggested, echoing the foolhardiness of the Walrus. To Stan, Ambien brought about a muddle of “euphoria and confusion.” Sounds like one hell of a sleepwalk—slipping through the mind’s back door out into a wilder expression of one’s self.
A neurological look into the Ambien Walrus’s effect on the brain
But inner expression and outward reality don’t necessarily align, especially when recreational drug use is involved. Ambien’s ability to aid with sleep can easily shift to dependency–if you start taking it regularly, you might not be able to sleep without it.
In her autobiographical essay, “Confessions of a Sleeping Pill Junkie,” Glamour writer Laurie Sandell tells all about her past with Ambien addiction. The amnesic effects can negatively impact one’s social life. Entire conversations with her beau—even intimate phone sessions—were lost to Ambien. Her daily regimen of Ambien nearly killed her. In one instance, she awoke to find herself neck-deep in a candle-lit bathtub brimming with water–if she had slid an inch or two further down, and she would’ve drowned in her sleep.
Paired with Ambien’s mood-altering effects, the raw anxiety that accompanies heavy drug-use can form a cyclical reliance. You’re restless, so you need the pill. You’re anxious, so you need the pill. You’re depressed because of your behavior on the pill, so you need the pill.
Dr. Yasmin Panahy, a board-certified internist from the Washington, D.C. area, says that, in order to curb usage, she and her colleagues give out a 30-day-supply at most, and never issue refills. “If the patient is not lucky enough to fall asleep within the narrow sedation window, then they succumb to the drug’s hypnotic effect and are prone to adverse consequences,” she tells me. “Ambien is habit-forming. My advice is to avoid daily use.”
Stories like Sandell’s led Barack Obama to declare America’s prescription drug abuse an “epidemic” in 2011. In a 2013 CDC report, four percent of Americans over the age of 20 were found to have used prescription sleeping aids in the past month. That same year, the FDA cut women’s recommended dosage for Ambien and other sleeping aids containing Zolpidem, since they metabolize the drug at a different rate than men.
In the “Drugs” episode of Chelsea Handler’s latest special, a four-part documentary miniseries for Netflix entitled Chelsea Does…, the comedienne chronicles her tumultuous relationship with sleeping pills. Under the care of a neuroscientist and friend, Heather, Chelsea chases a 10mg dosage of Ambien with two vodka cocktails–a mix that the show emphasizes is a no-no, since the depressants can work in tandem, potentially slowing the patient’s breathing to a halt. Within a few minutes, the effects of the drug are largely written on Chelsea’s face–her eyelids droop, her posture loosens, even her skin tone blanches a couple of shades. She looks disinterested in the world around her, like a drunkard in a state of yogic calm.
In order to get a qualitative read on how Ambien affects the mind, Heather challenges Chelsea to draw a family portrait while under the influence. “I’m a little girl very confused about why our parents don’t have a bank account,” Chelsea says, as she scribbles her family onto the page. The parents feature shattered eyes and detached mouths that make the sketch look like a doodle Picasso would leave on the backside of a napkin. And, of course, the following morning, Chelsea has no recollection of drawing any of it.
Later in the episode, Chelsea and her friends’ laughter becomes more frequent as they tear through marijuana-infused catering. Tomato bisque soup with OG Kush, or braised lamb and gnocchi with mari-butter? During the meal, a friend of hers asks her if she ever felt like she went too far with her drug-use. She considers, and says, “I feel like the toughest time in my life was when I was taking sleeping pills all the time, because I was completely reliant on them.” If you give Ambien the chance, it can, and will, suck you in. The Ambien Walrus has his tusks for a reason.
Sitting on the couch next to me, Dan pauses the episode as Chelsea is reflecting and turns to me. “Dude…I have done Ambien before. I completely forgot until this episode.” One moment, he was on a date with a girl he’d met on Tinder, bar-hopping before visiting her place. She suggested that they take a couple of sleeping pills, and then, the scene goes dark. The next thing he remembers is waking up, completely naked, wrapped in blankets next to her–neither of them had a clue as to what had transpired. For all we know, they could’ve had a naked pillow fight, or worn wigs and read children’s books back-to-front. But, under the amnesic hold of Ambien, neither of them had any recollection. “That was the last time I bought Plan B,” he tells me, “and it’s the last time I’ll ever used Ambien.”
These cautionary tales aren’t meant to negate the valid reasons to take Ambien. Insomniacs, who require immediate sleep, might have to take Ambien in order to get vital rest, while seeking treatment elsewhere to mitigate underlying issues. Ambien can be used to fight off jetlag before it hits–a conk-out pill for the translatlantic flight. But, for those who use the drug recreationally, and, in rare cases, even those that use the drug according to the label, there is a real risk that you might awake to strange, unexpected circumstances. Rock, paper, scissors. Wake up in bed, wake up in your car, wake up in custody. Only the Walrus truly knows.
Stay tuned to Milk to stay in a post-drug haze.
Main image by Kathryn Chadason. Additional images via Toothpaste for Dinner, imgur.
Ask the doctor: Is it okay to keep on taking Ambien for my sleeping problems?
Published: December, 2011
Q. I am 70, have had sleep problems, and have started to take Ambien every night. It seems to be working very well. Is it okay if I keep on taking it?
A. When Ambien (the generic name is zolpidem) was approved by the FDA in the early 1990s, it was supposed to be an improvement over the benzodiazepines like lorazepam (Ativan) and triazolam (Halcion) because it acted in a more targeted way and didn’t stay in the body as long. Other nonbenzodiazepines were subsequently approved, including Sonata (zaleplon) and Lunesta (eszopiclone).
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Included as part of the PRECAUTIONS section.
Complex Sleep Behaviors
Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake, may occur following the first or any subsequent use of AMBIEN. Patients can be seriously injured or injure others during complex sleep behaviors . Such injuries may result in a fatal outcome. Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sex) have also been reported. Patients usually do not remember these events. Postmarketing reports have shown that complex sleep behaviors may occur with AMBIEN alone at recommended doses, with or without the concomitant use of alcohol or other Central Nervous System (CNS) depressants . Discontinue AMBIEN immediately if a patient experiences a complex sleep behavior .
CNS-Depressant Effects And Next-Day Impairment
AMBIEN, like other sedative-hypnotic drugs, has CNS-depressant effects. Coadministration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression . Dosage adjustments of AMBIEN and of other concomitant CNS depressants may be necessary when AMBIEN is administered with such agents because of the potentially additive effects. The use of AMBIEN with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended .
The risk of next-day psychomotor impairment, including impaired driving, is increased if AMBIEN is taken with less than a full night of sleep remaining (7 to 8 hours); if a higher than the recommended dose is taken; if coadministered with other CNS depressants or alcohol; or if coadministered with other drugs that increase the blood levels of zolpidem. Patients should be warned against driving and other activities requiring complete mental alertness if AMBIEN is taken in these circumstances .
Vehicle drivers and machine operators should be warned that, as with other hypnotics, there may be a possible risk of adverse reactions including drowsiness, prolonged reaction time, dizziness, sleepiness, blurred/double vision, reduced alertness, and impaired driving the morning after therapy. In order to minimize this risk a full night of sleep (7-8 hours) is recommended.
Because AMBIEN can cause drowsiness and a decreased level of consciousness, patients, particularly the elderly, are at higher risk of falls.
Need To Evaluate For Comorbid Diagnoses
Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including zolpidem.
Severe Anaphylactic And Anaphylactoid Reactions
Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zolpidem. Some patients have had additional symptoms such as dyspnea, throat closing or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the throat, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with zolpidem should not be rechallenged with the drug.
Abnormal Thinking And Behavioral Changes
Abnormal thinking and behavior changes have been reported in patients treated with sedative/hypnotics, including AMBIEN. Some of these changes included decreased inhibition (e.g., aggressiveness and extroversion that seemed out of character), bizarre behavior, agitation and depersonalization. Visual and auditory hallucinations have been reported.
In controlled trials of AMBIEN 10 mg taken at bedtime <1% of adults with insomnia reported hallucinations. In a clinical trial, 7% of pediatric patients treated with AMBIEN 0.25 mg/kg taken at bedtime reported hallucinations versus 0% treated with placebo .
It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.
Use In Patients With Depression
In primarily depressed patients treated with sedative-hypnotics, worsening of depression, and suicidal thoughts and actions (including completed suicides), have been reported. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional overdosage is more common in this group of patients; therefore, the lowest number of tablets that is feasible should be prescribed for the patient at any one time.
Although studies with 10 mg zolpidem tartrate did not reveal respiratory depressant effects at hypnotic doses in healthy subjects or in patients with mild to moderate chronic obstructive pulmonary disease (COPD), a reduction in the Total Arousal Index, together with a reduction in lowest oxygen saturation and increase in the times of oxygen desaturation below 80% and 90%, was observed in patients with mild to moderate sleep apnea when treated with zolpidem compared to placebo. Since sedative-hypnotics have the capacity to depress respiratory drive, precautions should be taken if AMBIEN is prescribed to patients with compromised respiratory function. Postmarketing reports of respiratory insufficiency in patients receiving 10 mg of zolpidem tartrate, most of whom had pre-existing respiratory impairment, have been reported. The risk of respiratory depression should be considered prior to prescribing AMBIEN in patients with respiratory impairment including sleep apnea and myasthenia gravis.
Precipitation Of Hepatic Encephalopathy
Drugs affecting GABA receptors, such as zolpidem tartrate, have been associated with precipitation of hepatic encephalopathy in patients with hepatic insufficiency. In addition, patients with hepatic insufficiency do not clear zolpidem tartrate as rapidly as patients with normal hepatic function. Avoid AMBIEN use in patients with severe hepatic impairment as it may contribute to encephalopathy .
There have been reports of withdrawal signs and symptoms following the rapid dose decrease or abrupt discontinuation of zolpidem. Monitor patients for tolerance, abuse, and dependence .
Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Inform patients and their families about the benefits and risks of treatment with AMBIEN. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with AMBIEN and with each prescription refill. Review the AMBIEN Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that AMBIEN should be taken only as prescribed.
Instruct patients and their families that AMBIEN may cause complex sleep behaviors, including sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake. Serious injuries and death have occurred during complex sleep behavior episodes. Tell patients to discontinue AMBIEN and notify their healthcare provider immediately if they develop any of these symptoms .
Tell patients that AMBIEN has the potential to cause next-day impairment, and that this risk is increased if dosing instructions are not carefully followed. Tell patients to wait for at least 8 hours after dosing before driving or engaging in other activities requiring full mental alertness. Inform patients that impairment can be present despite feeling fully awake. Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients .
Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with zolpidem. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if any of them occur .
Tell patients to immediately report any suicidal thoughts.
Alcohol And Other Drugs
Ask patients about alcohol consumption, medicines they are taking, and drugs they may be taking without a prescription. Advise patients not to use AMBIEN if they drank alcohol that evening or before bed.
Tolerance, Abuse, And Dependence
Tell patients not to increase the dose of AMBIEN on their own, and to inform you if they believe the drug “does not work.”
Patients should be counseled to take AMBIEN right before they get into bed and only when they are able to stay in bed a full night (7-8 hours) before being active again. AMBIEN tablets should not be taken with or immediately after a meal. Advise patients NOT to take AMBIEN if they drank alcohol that evening.
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with AMBIEN. Advise patients that use of AMBIEN late in the third trimester may cause respiratory depression and sedation in neonates. Advise mothers who used AMBIEN during the late third trimester of pregnancy to monitor neonates for signs of sleepiness (more than usual), breathing difficulties, or limpness .
Advise breastfeeding mothers using AMBIEN to monitor infants for increased sleepiness, breathing difficulties, or limpness. Instruct breastfeeding mothers to seek immediate medical care if they notice these signs. A lactating woman may consider pumping and discarding breastmilk during treatment and for 23 hours after AMBIEN administration to minimize drug exposure to a breastfed infant .
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Zolpidem was administered to mice and rats for 2 years at oral doses of 4, 18, and 80 mg base/kg/day. In mice, these doses are approximately 2.5, 10, and 50 times the MRHD of 10 mg/day (8 mg zolpidem base) based on mg/m² body surface area and in rats, these doses are approximately 5, 20, and 100 times the MRHD based on mg/m² body surface area. No evidence of carcinogenic potential was observed in mice. In rats, renal tumors (lipoma, liposarcoma) were seen at the mid and high doses.
Zolpidem was negative in in vitro (bacterial reverse mutation, mouse lymphoma, and chromosomal aberration) and in vivo (mouse micronucleus) genetic toxicology assays.
Impairment Of Fertility
Zolpidem was administered to rats at 4, 20, and 100 mg base/kg/day, which are approximately 5, 25, and 120 times the MRHD of 10 mg/day (8 mg zolpidem base) based on mg/m² body surface area, prior to and during mating, and continuing in females through postpartum day 25. Zolpidem caused irregular estrus cycles and prolonged precoital intervals at the highest dose tested, which is approximately 120 times the MRHD based on mg/m² body surface area. The NOAEL for these effects is 25 times the MRHD based on a mg/m² body surface area. There was no impairment of fertility at any dose tested.
Use In Specific Populations
Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation . Published data on the use of zolpidem during pregnancy have not reported a clear association with zolpidem and major birth defects . Oral administration of zolpidem to pregnant rats and rabbits did not indicate a risk for adverse effects on fetal development at clinically relevant doses .
The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.
Fetal/Neonatal Adverse Reactions
Zolpidem crosses the placenta and may produce respiratory depression and sedation in neonates. Monitor neonates exposed to AMBIEN during pregnancy and labor for signs of excess sedation, hypotonia, and respiratory depression and manage accordingly.
Published data from observational studies, birth registries, and case reports on the use of zolpidem during pregnancy do not report a clear association with zolpidem and major birth defects.
There are limited postmarketing reports of severe to moderate cases of respiratory depression that occurred after birth in neonates whose mothers had taken zolpidem during pregnancy. These cases required artificial ventilation or intratracheal intubation. The majority of neonates recovered within hours to a few weeks after birth once treated.
Zolpidem has been shown to cross the placenta.
Oral administration of zolpidem to pregnant rats during the period of organogenesis at 4, 20, and 100 mg base/kg/day, which are approximately 5, 25, and 120 times the maximum recommended human dose (MRHD) of 10 mg/day (8 mg zolpidem base) based on mg/m² body surface area, caused delayed fetal development (incomplete fetal skeletal ossification) at maternally toxic (ataxia) doses 25 and 120 times the MRHD based on mg/m² body surface area.
Oral administration of zolpidem to pregnant rabbits during the period of organogenesis at 1, 4, and 16 mg base/kg/day, which are approximately 2.5, 10, and 40 times the MRHD of 10 mg/day (8 mg zolpidem base) based on mg/m² body surface area caused embryo-fetal death and delayed fetal development (incomplete fetal skeletal ossification) at a maternally toxic (decreased body weight gain) dose 40 times the MRHD based on mg/m² body surface area.
Oral administration of zolpidem to pregnant rats from day 15 of gestation through lactation at 4, 20, and 100 mg base/kg/day, which are approximately 5, 25, and 120 times the MRHD of 10 mg/day (8 mg zolpidem base) based on mg/m² body surface area, delayed offspring growth and decreased survival at doses 25 and 120 times, respectively, the MRHD based on mg/m² body surface area.
Limited data from published literature report the presence of zolpidem in human milk. There are reports of excess sedation in infants exposed to zolpidem through breastmilk . There is no information on the effects of zolpidem on milk production. The developmental and health benefits of breastfeeding should be considered along with the motherÃ¢â¬™s clinical need for AMBIEN and any potential adverse effects on the breastfed infant from AMBIEN or from the underlying maternal condition.
Infants exposed to AMBIEN through breastmilk should be monitored for excess sedation, hypotonia, and respiratory depression. A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 23 hours (approximately 5 elimination half-lives) after AMBIEN administration in order to minimize drug exposure to a breast fed infant.
AMBIEN is not recommended for use in children. Safety and effectiveness of zolpidem in pediatric patients below the age of 18 years have not been established.
In an 8-week study in pediatric patients (aged 6-17 years) with insomnia associated with attention-deficit/hyperactivity disorder (ADHD) an oral solution of zolpidem tartrate dosed at 0.25 mg/kg at bedtime did not decrease sleep latency compared to placebo. Psychiatric and nervous system disorders comprised the most frequent (>5%) treatment emergent adverse reactions observed with zolpidem versus placebo and included dizziness (23.5% vs 1.5%), headache (12.5% vs 9.2%), and hallucinations were reported in 7% of the pediatric patients who received zolpidem; none of the pediatric patients who received placebo reported hallucinations . Ten patients on zolpidem (7.4%) discontinued treatment due to an adverse reaction.
A total of 154 patients in U.S. controlled clinical trials and 897 patients in non-U.S. clinical trials who received zolpidem were ≥60 years of age. For a pool of U.S. patients receiving zolpidem at doses of ≤10 mg or placebo, there were three adverse reactions occurring at an incidence of at least 3% for zolpidem and for which the zolpidem incidence was at least twice the placebo incidence (i.e., they could be considered drug related).
The dose of AMBIEN in elderly patients is 5 mg to minimize adverse effects related to impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs .
Gender Difference In Pharmacokinetics
Women clear zolpidem tartrate from the body at a lower rate than men. Cmax and AUC parameters of zolpidem were approximately 45% higher at the same dose in female subjects compared with male subjects. Given the higher blood levels of zolpidem tartrate in women compared to men at a given dose, the recommended initial dose of AMBIEN for adult women is 5 mg, and the recommended dose for adult men is 5 or 10 mg.
In geriatric patients, clearance of zolpidem is similar in men and women. The recommended dose of AMBIEN in geriatric patients is 5 mg regardless of gender.
The recommended dose of AMBIEN in patients with mild to moderate hepatic impairment is 5 mg once daily immediately before bedtime. Avoid AMBIEN use in patients with severe hepatic impairment as it may contribute to encephalopathy .
What is Zolpidem (Ambien)?
Zolpidem is sold commercially under the names Ambien and Intermezzo and has been available in generic form for several years. You might see Zolpidem called a “non-benzodiazepine sleep aid” although putting it into the drug class imidazopyridines is more precise. You might also see it called a GABA-A receptor modulator or a Z-drug.
The technical name is N,N-dimethyl-2-(6-dimethyl-2-p-tolyl imidazopyridin-3-yl)acetamide and the formula is C19H21N3O.
Zolpidem comes as a tablet or pill, although it is sometimes sold as a spray that is applied to the tongue/mouth. The drug is taken directly before bed as it works quickly.
This drug is “labeled” (approved by the FDA) for only a short period of usage. Doctors are allowed to prescribe it for as long as they feel necessary, but as a patient you need to do your part and follow your doctor’s instructions.
Side effects that people often feel, especially when they start the medicine, include lightheadedness, difficulty keeping balance, and a feeling of being drugged up. More worrying side effects include rash, itching, and in a small minority of patients chest pain, shortness of breath, and blurred vision. Contact your doctor if you have any of these side effects.
Amnesia is a particularly worrisome side effect for some Ambien users. It is a temporary amnesia that blocks out memories from a certain time period. Look around the web and you can find anecdotes of people worried about their amnesia. It is not clear how common amnesia from zolipidem is. There has been some scientific work showing zolpidem may reduce the ability of the brain to turn short-term memories into long term memories. New research in that area shows people taking Ambien may be more likely to remember negative events. This disturbing news implies that the drug can actually make post-traumatic stress disorder worse.
Studies in rats found Zolpidem caused weight gain around the abdomen (visceral fat) and to move around less. Interestingly, the rats seemed to show more axiety when on the drug. When the drug was taken away the rats lost weight and became less anxious. These were high doses of zolipedem, higher than humans would take, after adjusting for body weight.
Sleeping pills tend to have abuse potential. A Harvard Medical School study concluded zolipdem “may possess moderate abuse potential that limits its clinical utility.” Different people have different reactions to drug, including the tendency to form dependence. You should always be careful when taking medicines that affect the sleep cycle.
A small study at the Henry Ford Hospital found that “chronic hypnotic use by primary insomniacs does not lead to dose escalation.” even when people had been taking the drug for a year. It was a small sample size and the FDA still labels the drug for only short-term use.
Zolpidem has long been thought to help people fall asleep but not to stay asleep. In other words, it works better for sleep-onset insomnia than sleep maintenance insomnia.
This would tend to indicate a short half-life in the body (which is indeed true) and few problems with morning grogginess. However, a recent study found the drug resulted in “clinically significant balance and cognitive impairments upon awakening from sleep”. The sleep inertia threat is such a problem that the researchers concluded that the use of drug was more dangerous than previously thought.
Along similar lines, a French study found zolipdem use results in slightly impaired driving ability the following day. A Chinese study found long-term zolipidem users had an increased risk for injury.
Intermezzo is a preparation of zolpidem specifically tailored for patients to take when they wake in the middle of the night. Purdue Pharma L.P. and Transcept Pharmaceuticals are marketing this formulation, which is the first drug every approved by the FDA for sleep maintenance insomnia.
Previously, Transcept Pharmaceuticals tried to get the FDA to approve a preparation of zolpidem for mid-night ingestion. The FDA said “no” citing fears of excessive sleep inertia come morning.
- Zolpidem for Recovery of Consciousness: Does It Work?
- Another study suggests zolpidem can enhance memory formation. If true, this contradicts other observations about amnesia.
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
- Complex Sleep Behaviors
- CNS-Depressant Effects and Next-Day Impairment
- Serious Anaphylactic and Anaphylactoid Reactions
- Abnormal Thinking and Behavior Changes
- Withdrawal effects
Clinical Trials Experience
Associated With Discontinuation Of Treatment
Data from a clinical study in which selective serotonin reuptake inhibitor (SSRI)-treated patients were given zolpidem revealed that four of the seven discontinuations during double-blind treatment with zolpidem (n=95) were associated with impaired concentration, continuing or aggravated depression, and manic reaction; one patient treated with placebo (n=97) was discontinued after an attempted suicide.
Most Commonly Observed Adverse Reactions In Controlled Trials
During short-term treatment (up to 10 nights) with AMBIEN at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were drowsiness (reported by 2% of zolpidem patients), dizziness (1%), and diarrhea (1%). During longer-term treatment (28 to 35 nights) with zolpidem at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were dizziness (5%) and drugged feelings (3%).
Adverse Reactions Observed At An Incidence Of ≥1% In Controlled Trials
The following tables enumerate treatment-emergent adverse reactions frequencies that were observed at an incidence equal to 1% or greater among patients with insomnia who received zolpidem tartrate and at a greater incidence than placebo in U.S. placebo-controlled trials. Events reported by investigators were classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms for the purpose of establishing event frequencies. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice, in which patient characteristics and other factors differ from those that prevailed in these clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigators involving related drug products and uses, since each group of drug trials is conducted under a different set of conditions. However, the cited figures provide the physician with a basis for estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the population studied.
The following table was derived from results of 11 placebo-controlled short-term U.S. efficacy trials involving zolpidem in doses ranging from 1.25 to 20 mg. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use.
Table 1: Incidences of Treatment-Emergent Adverse Reactions in Placebo-Controlled Clinical Trials Lasting up to 10 Nights (percentage of patients reporting)
|Body System Adverse Reaction*||Zolpidem (≤10 mg)
|Central and Peripheral Nervous System|
|* Reactions reported by at least 1% of patients treated with AMBIEN and at a greater frequency than placebo.|
The following table was derived from results of three placebo-controlled long-term efficacy trials involving AMBIEN (zolpidem tartrate). These trials involved patients with chronic insomnia who were treated for 28 to 35 nights with zolpidem at doses of 5, 10, or 15 mg. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use. The table includes only adverse events occurring at an incidence of at least 1% for zolpidem patients.
Table 2: Incidence of Treatment-Emergent Adverse Experiences in Placebo-Controlled Clinical Trials Lasting up to 35 Nights (percentage of patients reporting)
|Body System Adverse Event*||Zolpidem (≤10 mg)
|Autonomic Nervous System|
|Body as a Whole|
|Central and Peripheral Nervous System|
|Skin and Appendages|
|* Reactions reported by at least 1% of patients treated with AMBIEN and at a greater frequency than placebo.|
Dose Relationship For Adverse Reactions
There is evidence from dose comparison trials suggesting a dose relationship for many of the adverse reactions associated with zolpidem use, particularly for certain CNS and gastrointestinal adverse events.
Adverse Event Incidence Across The Entire Preapproval Database
AMBIEN was administered to 3,660 subjects in clinical trials throughout the U.S., Canada, and Europe. Treatment-emergent adverse events associated with clinical trial participation were recorded by clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals experiencing treatment-emergent adverse events, similar types of untoward events were grouped into a smaller number of standardized event categories and classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms.
The frequencies presented, therefore, represent the proportions of the 3,660 individuals exposed to zolpidem, at all doses, who experienced an event of the type cited on at least one occasion while receiving zolpidem. All reported treatment-emergent adverse events are included, except those already listed in the table above of adverse events in placebo-controlled studies, those coding terms that are so general as to be uninformative, and those events where a drug cause was remote. It is important to emphasize that, although the events reported did occur during treatment with AMBIEN, they were not necessarily caused by it.
Adverse events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in greater than 1/100 subjects; infrequent adverse events are those occurring in 1/100 to 1/1,000 patients; rare events are those occurring in less than 1/1,000 patients.
Autonomic nervous system: Infrequent: increased sweating, pallor, postural hypotension, syncope. Rare: abnormal accommodation, altered saliva, flushing, glaucoma, hypotension, impotence, increased saliva, tenesmus.
Cardiovascular system: Infrequent: cerebrovascular disorder, hypertension, tachycardia. Rare: angina pectoris, arrhythmia, arteritis, circulatory failure, extrasystoles, hypertension aggravated, myocardial infarction, phlebitis, pulmonary embolism, pulmonary edema, varicose veins, ventricular tachycardia.
Central and peripheral nervous system: Frequent: ataxia, confusion, euphoria, headache, insomnia, vertigo. Infrequent: agitation, anxiety, decreased cognition, detached, difficulty concentrating, dysarthria, emotional lability, hallucination, hypoesthesia, illusion, leg cramps, migraine, nervousness, paresthesia, sleeping (after daytime dosing), speech disorder, stupor, tremor. Rare: abnormal gait, abnormal thinking, aggressive reaction, apathy, appetite increased, decreased libido, delusion, dementia, depersonalization, dysphasia, feeling strange, hypokinesia, hypotonia, hysteria, intoxicated feeling, manic reaction, neuralgia, neuritis, neuropathy, neurosis, panic attacks, paresis, personality disorder, somnambulism, suicide attempts, tetany, yawning.
Gastrointestinal system: Frequent: dyspepsia, hiccup, nausea. Infrequent: anorexia, constipation, dysphagia, flatulence, gastroenteritis, vomiting. Rare: enteritis, eructation, esophagospasm, gastritis, hemorrhoids, intestinal obstruction, rectal hemorrhage, tooth caries.
Hematologic and lymphatic system: Rare: anemia, hyperhemoglobinemia, leukopenia, lymphadenopathy, macrocytic anemia, purpura, thrombosis.
Immunologic system: Infrequent: infection. Rare: abscess herpes simplex herpes zoster, otitis externa, otitis media.
Liver and biliary system: Infrequent: abnormal hepatic function, increased SGPT. Rare: bilirubinemia, increased SGOT.
Metabolic and nutritional: Infrequent: hyperglycemia, thirst. Rare: gout, hypercholesteremia, hyperlipidemia, increased alkaline phosphatase, increased BUN, periorbital edema.
Musculoskeletal system: Frequent: arthralgia, myalgia. Infrequent: arthritis. Rare: arthrosis, muscle weakness, sciatica, tendinitis.
Reproductive system: Infrequent: menstrual disorder, vaginitis. Rare: breast fibroadenosis, breast neoplasm, breast pain. Respiratory system: Frequent: upper respiratory infection, lower respiratory infection. Infrequent: bronchitis, coughing, dyspnea, rhinitis. Rare: bronchospasm, respiratory depression, epistaxis, hypoxia, laryngitis, pneumonia.
Skin and appendages: Infrequent: pruritus. Rare: acne, bullous eruption, dermatitis, furunculosis, injection-site inflammation, photosensitivity reaction, urticaria.
Special senses: Frequent: diplopia, vision abnormal. Infrequent: eye irritation, eye pain, scleritis, taste perversion, tinnitus. Rare: conjunctivitis, corneal ulceration, lacrimation abnormal, parosmia, photopsia.
Urogenital system: Frequent: urinary tract infection. Infrequent: cystitis, urinary incontinence. Rare: acute renal failure, dysuria, micturition frequency, nocturia, polyuria, pyelonephritis, renal pain, urinary retention.
The following adverse reactions have been identified during postapproval use of AMBIEN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Liver and biliary system: acute hepatocellular, cholestatic or mixed liver injury with or without jaundice (i.e., bilirubin >2 x ULN, alkaline phosphatase ≥2 x ULN, transaminase ≥5 x ULN).
Read the entire FDA prescribing information for Ambien (Zolpidem Tartrate)