Calm 30mg by Wilshire Laboratories
Product Description
Temazepam:
(brand names Restoril and Normison, among others) is an intermediate-acting 3-hydroxy hypnotic of the benzodiazepine class of psychoactive drugs. Temazepam is approved for the short-term treatment of insomnia. In addition, temazepam has anxiolytic (anti-anxiety), anticonvulsant, and skeletal muscle relaxant properties.
History:
Temazepam was first synthesized in 1964, but it first came into use in 1969 when its ability to counter insomnia was realized.By the late 1980s, temazepam was one of the most popular and widely prescribed hypnotics on the market and it became one of the most widely prescribed drugs.
Indications:
Temazepam is a hypnotic agent. In sleep laboratory studies, temazepam significantly decreased the number of nightly awakeningsbut has the drawback of distorting the normal sleep pattern.
Temazepam is officially indicated for severe insomnia and other severe or disabling sleep disorders. The prescribing guidelines in the UK limit the prescribing of hypnotics to two-to-four weeks due to concerns of tolerance and dependence.
The United States Air Force uses temazepam 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.[citation needed]
Contraindications:
Use of temazepam should be avoided, when possible, in individuals with the following conditions:
Ataxia (gross lack of coordination of muscle movements)
Severe hypoventilation
Acute narrow-angle glaucoma
Severe hepatic deficiencies (hepatitis and liver cirrhosis decrease elimination by a factor of 2)
Severe renal deficiencies (e.g. patients on dialysis)
Sleep apnea[8]
Severe depression, particularly when accompanied by suicidal tendencies
Acute intoxication with alcohol, narcotics, or other psychoactive substances
Myasthenia gravis (autoimmune disorder causing muscle weakness)
Hypersensitivity or allergy to any drug in the benzodiazepine class
Special caution needed:
Temazepam should not be used in pregnancy, as it may cause harm to the fetus. The safety and effectiveness of temazepam has not been established in children; therefore temazepam should generally not be given to individuals under 18 years of age, and should not be used at all in children under 6 months old. Benzodiazepines also require special caution if used in the elderly, alcohol or drug-dependent individuals and individuals with comorbid psychiatric disorders.
Temazepam, similar to other benzodiazepines and nonbenzodiazepine hypnotic drugs causes impairments in body balance and standing steadiness in individuals who wake up at night or the next morning. Falls and hip fractures are frequently reported. The combination with alcohol increases these impairments. Partial, but incomplete tolerance develops to these impairments.The smallest possible effective dose should be used in elderly or very ill patients, as there is a risk of apnea and/or cardiac arrest. This risk is increased when temazepam is given concomitantly with other drugs that depress the central nervous system.
Patients at a high risk for abuse and dependence:
Because benzodiazepines can be abused and lead to dependence, their use should be avoided in people in certain particularly high risk groups. High risk groups include people with a history ofalcohol or drug abuse or dependence, emotionally unstable patients, people with severe personality disorders (such as Borderline Personality Disorder). If temazepam is indeed prescribed to people in these groups, they should generally be monitored very closely for signs of abuse and development of dependence.
Adverse effects:
Common:
Side effects typical of hypnotic benzodiazepines are related to CNS depression, and include somnolence, dizziness, fatigue, ataxia, headache, lethargy, impairment of memory and learning, longerreaction time and impairment of motor functions (including coordination problems),slurred speech, decreased physical performance, numbed emotions, reduced alertness, muscle weakness, blurred vision (in higher doses), and inattention. Euphoria was rarely reported with the use of temazepam. According to the FDA, temazepam had an incidence of euphoria of 1.5%, much more rarely reported than headaches and diarrhea.Anterograde amnesia may also develop, as may respiratory depression in higher doses.
Less common:
Hyperhydrosis, hypotension, burning eyes, changes in libido, hallucinations, faintness, nystagmus, vomiting, pruritus, gastrointestinal disturbances, nightmares, palpitation and paradoxical reactions including restlessness, aggression, violence, overstimulation and agitation have been reported, but are rare (less than 0.5%).
Before taking temazepam, one should ensure that at least 8 hours are available to dedicate to sleep. Failing to do so can increase the side effects of the drug.
The use of this drug in combination with alcohol potentiates the side effects, and can lead to toxicity and death.
Though rare, residual "hangover" effects after nighttime administration of temazepam such as sleepiness, impaired psychomotor and cognitive functions may persist into the next day, which may impair the ability of users to drive safely or may increase the risks of falls and hip fractures.
Tolerance and physical dependence:
See also:
benzodiazepine withdrawal syndrome
Tolerance:
Chronic or excessive use of temazepam may cause drug tolerance, which can develop rapidly,so this drug is therefore not recommended for long-term use.In 1979 the Institute of Medicine (USA) and the National Institute on Drug Abuse stated that most hypnotics lose their sleep-inducing properties after about 3 to 14 days.In use longer than 1–2 weeks, tolerance will frequently develop towards the ability of temazepam to maintain sleep, so that the drug loses effectiveness.Some studies have observed tolerance to temazepam after as little as one week's use.Another study examined the short-term effects of the accumulation of temazepam over 7 days in elderly inpatients, and found that little tolerance developed during the accumulation of the drug.Other studies examined the use of temazepam over six days and saw no evidence of tolerance.A study in 11 young male subjects showed that significant tolerance occurs to temazepam's thermoregulatory effects and sleep inducing properties after 1 week of use of 30 mg temazepam. Body temperature is well correlated with the sleep inducing or insomnia promoting properties of drugs.
In one study the drug sensitivity of people who had used temazepam for 1–20 years was no different from that of controls.An additional study, in which at least one of the authors is employed by multiple drug companies, examined the efficacy of temazepam treatment on chronic insomnia over three months and saw no drug tolerance, with the authors even suggesting that the drug might become more effective over time.
Establishing continued efficacy beyond a few weeks can be complicated by the difficulty in distinguishing between the return of the original insomnia complaint and withdrawal or rebound related insomnia. Sleep EEG studies on hypnotic benzodiazepines show that tolerance tends to occur completely after one to four weeks with sleep EEG returning to pretreatment levels. The paper concluded that due to concerns about long term use both toxicity and tolerance and dependence as well as controversy over long term efficacy that wise prescribers should restrict benzodiazepines to a few weeks and avoid continuing prescriptions for months or years.A review of the literature found that non-pharmacological treatment options were a more effective treatment option for insomnia due to their sustained improvements in sleep quality.
Product Description
Temazepam:
(brand names Restoril and Normison, among others) is an intermediate-acting 3-hydroxy hypnotic of the benzodiazepine class of psychoactive drugs. Temazepam is approved for the short-term treatment of insomnia. In addition, temazepam has anxiolytic (anti-anxiety), anticonvulsant, and skeletal muscle relaxant properties.
History:
Temazepam was first synthesized in 1964, but it first came into use in 1969 when its ability to counter insomnia was realized.By the late 1980s, temazepam was one of the most popular and widely prescribed hypnotics on the market and it became one of the most widely prescribed drugs.
Indications:
Temazepam is a hypnotic agent. In sleep laboratory studies, temazepam significantly decreased the number of nightly awakeningsbut has the drawback of distorting the normal sleep pattern.
Temazepam is officially indicated for severe insomnia and other severe or disabling sleep disorders. The prescribing guidelines in the UK limit the prescribing of hypnotics to two-to-four weeks due to concerns of tolerance and dependence.
The United States Air Force uses temazepam 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.[citation needed]
Contraindications:
Use of temazepam should be avoided, when possible, in individuals with the following conditions:
Ataxia (gross lack of coordination of muscle movements)
Severe hypoventilation
Acute narrow-angle glaucoma
Severe hepatic deficiencies (hepatitis and liver cirrhosis decrease elimination by a factor of 2)
Severe renal deficiencies (e.g. patients on dialysis)
Sleep apnea[8]
Severe depression, particularly when accompanied by suicidal tendencies
Acute intoxication with alcohol, narcotics, or other psychoactive substances
Myasthenia gravis (autoimmune disorder causing muscle weakness)
Hypersensitivity or allergy to any drug in the benzodiazepine class
Special caution needed:
Temazepam should not be used in pregnancy, as it may cause harm to the fetus. The safety and effectiveness of temazepam has not been established in children; therefore temazepam should generally not be given to individuals under 18 years of age, and should not be used at all in children under 6 months old. Benzodiazepines also require special caution if used in the elderly, alcohol or drug-dependent individuals and individuals with comorbid psychiatric disorders.
Temazepam, similar to other benzodiazepines and nonbenzodiazepine hypnotic drugs causes impairments in body balance and standing steadiness in individuals who wake up at night or the next morning. Falls and hip fractures are frequently reported. The combination with alcohol increases these impairments. Partial, but incomplete tolerance develops to these impairments.The smallest possible effective dose should be used in elderly or very ill patients, as there is a risk of apnea and/or cardiac arrest. This risk is increased when temazepam is given concomitantly with other drugs that depress the central nervous system.
Patients at a high risk for abuse and dependence:
Because benzodiazepines can be abused and lead to dependence, their use should be avoided in people in certain particularly high risk groups. High risk groups include people with a history ofalcohol or drug abuse or dependence, emotionally unstable patients, people with severe personality disorders (such as Borderline Personality Disorder). If temazepam is indeed prescribed to people in these groups, they should generally be monitored very closely for signs of abuse and development of dependence.
Adverse effects:
Common:
Side effects typical of hypnotic benzodiazepines are related to CNS depression, and include somnolence, dizziness, fatigue, ataxia, headache, lethargy, impairment of memory and learning, longerreaction time and impairment of motor functions (including coordination problems),slurred speech, decreased physical performance, numbed emotions, reduced alertness, muscle weakness, blurred vision (in higher doses), and inattention. Euphoria was rarely reported with the use of temazepam. According to the FDA, temazepam had an incidence of euphoria of 1.5%, much more rarely reported than headaches and diarrhea.Anterograde amnesia may also develop, as may respiratory depression in higher doses.
Less common:
Hyperhydrosis, hypotension, burning eyes, changes in libido, hallucinations, faintness, nystagmus, vomiting, pruritus, gastrointestinal disturbances, nightmares, palpitation and paradoxical reactions including restlessness, aggression, violence, overstimulation and agitation have been reported, but are rare (less than 0.5%).
Before taking temazepam, one should ensure that at least 8 hours are available to dedicate to sleep. Failing to do so can increase the side effects of the drug.
The use of this drug in combination with alcohol potentiates the side effects, and can lead to toxicity and death.
Though rare, residual "hangover" effects after nighttime administration of temazepam such as sleepiness, impaired psychomotor and cognitive functions may persist into the next day, which may impair the ability of users to drive safely or may increase the risks of falls and hip fractures.
Tolerance and physical dependence:
See also:
benzodiazepine withdrawal syndrome
Tolerance:
Chronic or excessive use of temazepam may cause drug tolerance, which can develop rapidly,so this drug is therefore not recommended for long-term use.In 1979 the Institute of Medicine (USA) and the National Institute on Drug Abuse stated that most hypnotics lose their sleep-inducing properties after about 3 to 14 days.In use longer than 1–2 weeks, tolerance will frequently develop towards the ability of temazepam to maintain sleep, so that the drug loses effectiveness.Some studies have observed tolerance to temazepam after as little as one week's use.Another study examined the short-term effects of the accumulation of temazepam over 7 days in elderly inpatients, and found that little tolerance developed during the accumulation of the drug.Other studies examined the use of temazepam over six days and saw no evidence of tolerance.A study in 11 young male subjects showed that significant tolerance occurs to temazepam's thermoregulatory effects and sleep inducing properties after 1 week of use of 30 mg temazepam. Body temperature is well correlated with the sleep inducing or insomnia promoting properties of drugs.
In one study the drug sensitivity of people who had used temazepam for 1–20 years was no different from that of controls.An additional study, in which at least one of the authors is employed by multiple drug companies, examined the efficacy of temazepam treatment on chronic insomnia over three months and saw no drug tolerance, with the authors even suggesting that the drug might become more effective over time.
Establishing continued efficacy beyond a few weeks can be complicated by the difficulty in distinguishing between the return of the original insomnia complaint and withdrawal or rebound related insomnia. Sleep EEG studies on hypnotic benzodiazepines show that tolerance tends to occur completely after one to four weeks with sleep EEG returning to pretreatment levels. The paper concluded that due to concerns about long term use both toxicity and tolerance and dependence as well as controversy over long term efficacy that wise prescribers should restrict benzodiazepines to a few weeks and avoid continuing prescriptions for months or years.A review of the literature found that non-pharmacological treatment options were a more effective treatment option for insomnia due to their sustained improvements in sleep quality.
