Insomnia
Zolpidem Tartrate 10 MG tablets
Zolpidem is approved for the short-term (usually about two to six weeks) treatment of insomnia, and it has been studied for nightly use up to six months in a single-blind trial published in 1991,[13] an open-label study lasting 180 days published in 1992 (with continued efficacy in patients who had kept taking it as of 180 days after the end of the trial),[14] and in an open-label trial lasting 179 days published in 1993.[15]
The United States Air Force uses zolpidem as one of the hypnotics approved as "no-go pills" to help aviators and special duty personnel sleep in support of mission readiness. "Ground tests" are required prior to authorization being issued to use the medication in an operational situation.[16]
[edit]Brain injury
A case study performed at the Toulouse University Hospital using PET showed zolpidem repeatably improves brain function and mobility of a patient immobilized by akinetic mutism caused by hypoxia.[17]
Recently, zolpidem has been cited in various medical reports mainly in the United Kingdom as waking persistent vegetative state (PVS) patients, and dramatically improving the conditions of people with brain injuries.[18][19][20][21][22] Results from phase IIa trials were expected in June 2007. The trials are being conducted by Regen Therapeutics of the UK, who have a patent pending on this new use for Zolpidem.[23][24]
[edit]Coma
Zolpidem has recently been very strongly related to certain instances of patients in a minimally conscious coma state being brought to a fully conscious state. While it was initially given to these supposed permanent coma patients to put them to sleep, it actually brought them to a fully conscious state in which they were capable of communicating and interacting for the first time in years. CT scans have shown that the use of the drug actually does dramatically increase the activity in the frontal lobe of the brain in some patients in a minimally conscious state. Large-scale studies are currently being done to see whether it has the same universal effect on all or most patients in a minimally conscious state.[25] It may be that zolpidem's ability to stimulate the brain, particularly in the semi-comatose, may be related to one of its side-effects, which sometimes causes sleepwalking and other activity while asleep, that appears to observers to be fully conscious activity.
[edit]Miscellaneous off-label
Zolpidem is also used off-label to treat restless leg syndrome and as an antiemetic.
As is the case with many prescription sedative/hypnotic drugs, it is sometimes used by stimulant users to "come down" after the use of stimulants such as amphetamines (including methamphetamine), cocaine, and MDMA (ecstasy).[26]
[edit]Side effects
Side-effects at any dose may include:
Anterograde amnesia
Hallucinations, through all physical senses, of varying intensity
Delusions
Altered thought patterns
Ataxia or poor motor coordination, difficulty maintaining balance[27]
Euphoria and/or dysphoria
Increased appetite
Increased libido
Amnesia
Impaired judgment and reasoning
Uninhibited extroversion in social or interpersonal settings
Increased impulsivity
When stopped, rebound insomnia may occur
Headaches in some people
Memory loss in some people
A clinical trial found that after administration of zolpidem trial subjects tended to feel weak, fatigued and developed an antagonistic mood.[28]
Some users take zolpidem recreationally for some of these side-effects, notably sedation, hallucinations and euphoria. Zolpidem becomes addictive if taken for extended periods of time, due to drug tolerance and physical dependence or the euphoria it can sometimes produce. Under the influence of the drug, it is common for one to take more zolpidem than is necessary, due to either forgetting that one has already taken a pill (elderly users are particularly at risk here) or knowingly taking more than the prescribed dosage. The release of AmbienCR (zolpidem tartrate extended release) in the United States renewed interest in the drug among recreational drug users.
Some users have reported unexplained sleepwalking while using zolpidem, and a few have reported driving, binge eating, sleep talking, and performing other daily tasks while sleeping. Research by Australia's National Prescribing Service found that these events mostly occur after the first dosage taken or within a few days of starting therapy.[29] Rare reports of sexual parasomnia episodes related to zolpidem intake have also been reported.[30] The sleepwalker can sometimes perform these tasks as normally as they might if they were awake. They can sometimes carry on complex conversations and respond appropriately to questions or statements so much so that the observer may believe the sleepwalker to be awake. This is similar to, but unlike, typical sleep talking, which can usually be identified easily and is characterised by incoherent speech that often has no relevance to the situation or that is so disorganised as to be completely unintelligible. A person under the influence of this medication may seem fully aware of their environment even though they are still asleep. This can bring about concerns for the safety of the sleepwalker and others. These side-effects may be related to the mechanism that also causes zolpidem to produce its hypnotic properties.[31] It is unclear whether the drug is responsible for the behavior, but a class-action lawsuit was filed against Sanofi-Aventis in March 2006 on behalf of those that reported symptoms.[32]
Residual 'hangover' effects such as sleepiness, impaired psychomotor and cognitive after nighttime administration may persist into the next day which may impair the ability of users to drive safely, increase risks of falls and hip fractures.[33]
The Sydney Morning Herald in Australia reported in 2007 that a man who fell 30 meters to his death from a high-rise unit balcony may have been sleepwalking under the influence of Stilnox. The coverage prompted over 40 readers to contact the newspaper with their own accounts of Stilnox-related automatism, and as of March 2007, the drug was under review by the Adverse Drug Reactions Advisory Committee.[34]
In February 2008, the Australian Therapeutic Goods Administration attached a Black Box Warning to zolpidem, stating that "Zolpidem may be associated with potentially dangerous complex sleep-related behaviours which may include sleep walking, sleep driving and other bizarre behaviours. Zolpidem is not to be taken with alcohol. Caution is needed with other CNS depressant drugs. Limit use to four weeks maximum under close medical supervision."[35]This report received widespread media coverage[36]after the death of Australian student Mairead Costigan, who fell 20m from the Sydney Harbour Bridge while under the influence of Stilnox.[37]
[edit]Tolerance, dependence, and withdrawal
Ambien tablets
A review medical publication found that long term use of zolpidem is associated with drug tolerance, drug dependence, rebound insomnia and CNS related adverse effects. It was recommended that zolpidem be used for short periods of time using the lowest effective dose. Non-pharmacological treatment options however, were found to have sustained improvements in sleep quality.[38] Animal studies of the tolerance inducing properties have shown that in rodents zolpidem has less tolerance producing potential than benzodiazepines but in primates the tolerance producing potential of zolpidem was the same as that of benzodiazepines.[39] Tolerance can develop in some people to the effects of zolpidem in just a few weeks. Abrupt withdrawal of zolpidem may cause delirium, seizures or other severe effects, especially if used for prolonged periods and at high dosages.[40][41][42] When drug tolerance and physical dependence to zolpidem has developed, treatment usually entails a gradual dose reduction over a period of months in order to minimise withdrawal symptoms which can resemble those seen during benzodiazepine withdrawal. Failing that, an alternative method which may be necessary for some patients is a switch to a benzodiazepine equivalent dose of a longer acting benzodiazepine drug such as diazepam or chlordiazepoxide followed by a gradual reduction in dosage of the long acting benzodiazepine. Sometimes for difficult to treat patients an inpatient flumazenil rapid detoxification program can be used to detox from a zolpidem drug dependence or addiction.[43] However, it should be noted that this treatment approach closely parallels that of the highly controversial rapid opiate detoxification therapy, which critics claim lacks long-term efficacy and can actually be detrimental to a patient's long-term recovery. Additionally, there have been many questions raised about the ethics as well as safety of rapid detox following a number of deaths resulting from the procedure.[44][45]
Alcohol has cross tolerance with GABAa receptor positive modulators such as the benzodiazepines and the nonbenzodiazepine drugs. For this reason alcoholics or recovering alcoholics may be at increased risk of physical dependency on zolpidem. Also, alcoholics and drug abusers may be at increased risk of abusing and or becoming psychologically dependent on zolpidem. Zolpidem should be avoided in those with a history of Alcoholism, drug misuse, or in those with history of physical dependency or psychological dependency on sedative-hypnotic drugs.
[edit]Special precautions
[edit]Driving
Use of zolpidem may impair driving skills with a resultant increased risk of road traffic accidents. This adverse effect is not unique to zolpidem but also occurs with other hypnotic drugs. Caution should be exercised by motor vehicle drivers.[46]
[edit]Elderly
The elderly are more sensitive to the effects of hypnotics including zolpidem. Zolpidem causes an increased risk of falls and may induce cognitive adverse effects.[47]
Zolpidem Tartrate 10 MG tablets
Zolpidem is approved for the short-term (usually about two to six weeks) treatment of insomnia, and it has been studied for nightly use up to six months in a single-blind trial published in 1991,[13] an open-label study lasting 180 days published in 1992 (with continued efficacy in patients who had kept taking it as of 180 days after the end of the trial),[14] and in an open-label trial lasting 179 days published in 1993.[15]
The United States Air Force uses zolpidem as one of the hypnotics approved as "no-go pills" to help aviators and special duty personnel sleep in support of mission readiness. "Ground tests" are required prior to authorization being issued to use the medication in an operational situation.[16]
[edit]Brain injury
A case study performed at the Toulouse University Hospital using PET showed zolpidem repeatably improves brain function and mobility of a patient immobilized by akinetic mutism caused by hypoxia.[17]
Recently, zolpidem has been cited in various medical reports mainly in the United Kingdom as waking persistent vegetative state (PVS) patients, and dramatically improving the conditions of people with brain injuries.[18][19][20][21][22] Results from phase IIa trials were expected in June 2007. The trials are being conducted by Regen Therapeutics of the UK, who have a patent pending on this new use for Zolpidem.[23][24]
[edit]Coma
Zolpidem has recently been very strongly related to certain instances of patients in a minimally conscious coma state being brought to a fully conscious state. While it was initially given to these supposed permanent coma patients to put them to sleep, it actually brought them to a fully conscious state in which they were capable of communicating and interacting for the first time in years. CT scans have shown that the use of the drug actually does dramatically increase the activity in the frontal lobe of the brain in some patients in a minimally conscious state. Large-scale studies are currently being done to see whether it has the same universal effect on all or most patients in a minimally conscious state.[25] It may be that zolpidem's ability to stimulate the brain, particularly in the semi-comatose, may be related to one of its side-effects, which sometimes causes sleepwalking and other activity while asleep, that appears to observers to be fully conscious activity.
[edit]Miscellaneous off-label
Zolpidem is also used off-label to treat restless leg syndrome and as an antiemetic.
As is the case with many prescription sedative/hypnotic drugs, it is sometimes used by stimulant users to "come down" after the use of stimulants such as amphetamines (including methamphetamine), cocaine, and MDMA (ecstasy).[26]
[edit]Side effects
Side-effects at any dose may include:
Anterograde amnesia
Hallucinations, through all physical senses, of varying intensity
Delusions
Altered thought patterns
Ataxia or poor motor coordination, difficulty maintaining balance[27]
Euphoria and/or dysphoria
Increased appetite
Increased libido
Amnesia
Impaired judgment and reasoning
Uninhibited extroversion in social or interpersonal settings
Increased impulsivity
When stopped, rebound insomnia may occur
Headaches in some people
Memory loss in some people
A clinical trial found that after administration of zolpidem trial subjects tended to feel weak, fatigued and developed an antagonistic mood.[28]
Some users take zolpidem recreationally for some of these side-effects, notably sedation, hallucinations and euphoria. Zolpidem becomes addictive if taken for extended periods of time, due to drug tolerance and physical dependence or the euphoria it can sometimes produce. Under the influence of the drug, it is common for one to take more zolpidem than is necessary, due to either forgetting that one has already taken a pill (elderly users are particularly at risk here) or knowingly taking more than the prescribed dosage. The release of AmbienCR (zolpidem tartrate extended release) in the United States renewed interest in the drug among recreational drug users.
Some users have reported unexplained sleepwalking while using zolpidem, and a few have reported driving, binge eating, sleep talking, and performing other daily tasks while sleeping. Research by Australia's National Prescribing Service found that these events mostly occur after the first dosage taken or within a few days of starting therapy.[29] Rare reports of sexual parasomnia episodes related to zolpidem intake have also been reported.[30] The sleepwalker can sometimes perform these tasks as normally as they might if they were awake. They can sometimes carry on complex conversations and respond appropriately to questions or statements so much so that the observer may believe the sleepwalker to be awake. This is similar to, but unlike, typical sleep talking, which can usually be identified easily and is characterised by incoherent speech that often has no relevance to the situation or that is so disorganised as to be completely unintelligible. A person under the influence of this medication may seem fully aware of their environment even though they are still asleep. This can bring about concerns for the safety of the sleepwalker and others. These side-effects may be related to the mechanism that also causes zolpidem to produce its hypnotic properties.[31] It is unclear whether the drug is responsible for the behavior, but a class-action lawsuit was filed against Sanofi-Aventis in March 2006 on behalf of those that reported symptoms.[32]
Residual 'hangover' effects such as sleepiness, impaired psychomotor and cognitive after nighttime administration may persist into the next day which may impair the ability of users to drive safely, increase risks of falls and hip fractures.[33]
The Sydney Morning Herald in Australia reported in 2007 that a man who fell 30 meters to his death from a high-rise unit balcony may have been sleepwalking under the influence of Stilnox. The coverage prompted over 40 readers to contact the newspaper with their own accounts of Stilnox-related automatism, and as of March 2007, the drug was under review by the Adverse Drug Reactions Advisory Committee.[34]
In February 2008, the Australian Therapeutic Goods Administration attached a Black Box Warning to zolpidem, stating that "Zolpidem may be associated with potentially dangerous complex sleep-related behaviours which may include sleep walking, sleep driving and other bizarre behaviours. Zolpidem is not to be taken with alcohol. Caution is needed with other CNS depressant drugs. Limit use to four weeks maximum under close medical supervision."[35]This report received widespread media coverage[36]after the death of Australian student Mairead Costigan, who fell 20m from the Sydney Harbour Bridge while under the influence of Stilnox.[37]
[edit]Tolerance, dependence, and withdrawal
Ambien tablets
A review medical publication found that long term use of zolpidem is associated with drug tolerance, drug dependence, rebound insomnia and CNS related adverse effects. It was recommended that zolpidem be used for short periods of time using the lowest effective dose. Non-pharmacological treatment options however, were found to have sustained improvements in sleep quality.[38] Animal studies of the tolerance inducing properties have shown that in rodents zolpidem has less tolerance producing potential than benzodiazepines but in primates the tolerance producing potential of zolpidem was the same as that of benzodiazepines.[39] Tolerance can develop in some people to the effects of zolpidem in just a few weeks. Abrupt withdrawal of zolpidem may cause delirium, seizures or other severe effects, especially if used for prolonged periods and at high dosages.[40][41][42] When drug tolerance and physical dependence to zolpidem has developed, treatment usually entails a gradual dose reduction over a period of months in order to minimise withdrawal symptoms which can resemble those seen during benzodiazepine withdrawal. Failing that, an alternative method which may be necessary for some patients is a switch to a benzodiazepine equivalent dose of a longer acting benzodiazepine drug such as diazepam or chlordiazepoxide followed by a gradual reduction in dosage of the long acting benzodiazepine. Sometimes for difficult to treat patients an inpatient flumazenil rapid detoxification program can be used to detox from a zolpidem drug dependence or addiction.[43] However, it should be noted that this treatment approach closely parallels that of the highly controversial rapid opiate detoxification therapy, which critics claim lacks long-term efficacy and can actually be detrimental to a patient's long-term recovery. Additionally, there have been many questions raised about the ethics as well as safety of rapid detox following a number of deaths resulting from the procedure.[44][45]
Alcohol has cross tolerance with GABAa receptor positive modulators such as the benzodiazepines and the nonbenzodiazepine drugs. For this reason alcoholics or recovering alcoholics may be at increased risk of physical dependency on zolpidem. Also, alcoholics and drug abusers may be at increased risk of abusing and or becoming psychologically dependent on zolpidem. Zolpidem should be avoided in those with a history of Alcoholism, drug misuse, or in those with history of physical dependency or psychological dependency on sedative-hypnotic drugs.
[edit]Special precautions
[edit]Driving
Use of zolpidem may impair driving skills with a resultant increased risk of road traffic accidents. This adverse effect is not unique to zolpidem but also occurs with other hypnotic drugs. Caution should be exercised by motor vehicle drivers.[46]
[edit]Elderly
The elderly are more sensitive to the effects of hypnotics including zolpidem. Zolpidem causes an increased risk of falls and may induce cognitive adverse effects.[47]
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o a.m ,what are all these people doing out here.we walked for what seemed like a hour,but we wre only 5 feet away from the house.then i saw a dead midget in a tuxedo,behind my friends house.i felt sad then.the rest of the night was a blur.i remember getting everyone to smell my finger.[because i had fingered my girlfrien earlier theat night].one guy played along ,and said it smell like butterscotch.[if anyone has seen the movie 'kids' then they get the joke].in all it was a great night that i will always remember.i can't wait to the next trip. Peace. Life is to short so love the one ya got-
