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Restoril (Temazepam) 30mg
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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 of alcohol 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, longer reaction 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.

Overdose

Overdosage of temazepam results in increasing CNS effects, including:

  • Somnolence (difficulty staying awake)
  • Mental confusion
  • Respiratory depression
  • Hypotension
  • Impaired motor functions
  • Impaired or absent reflexes
  • Impaired coordination
  • Impaired balance
  • Dizziness
  • Coma
  • Death

Temazepam had the highest rate of drug intoxication, including overdose, among the common benzodiazepines in cases with and without combination with alcohol in a 1985 study.Temazepam and nitrazepam were the two benzodiazepines most commonly detected in overdose-related deaths in an Australian study of drug deaths.A 1993 British study found temazepam to have the highest number of deaths per million prescriptions among medications commonly prescribed in the 1980s (11.9, versus 5.9 for benzodiazepines overall, taken with or without alcohol).

A 1995 Australian study of patients admitted to hospital after benzodiazepine overdose corroborated these results, and found temazepam overdose much more likely to lead to coma in comparison to other benzodiazepines (odds ratio 1.86). The authors note that several factors, such as differences in potency, receptor affinity, and rate of absorption between benzodiazepines could explain this higher toxicity.

Although benzodiazepines have a high therapeutic index, temazepam is one of the more dangerous of this class of drugs.

The combination of alcohol and temazepam makes death by alcohol poisoning more likely.


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