Restoril tolerance and dependence


Chronic or excessive use of Restoril 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 restoril to maintain sleep, so that the drug loses effectiveness. Some studies have observed tolerance to restoril 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 restoril over six days and saw no evidence of tolerance. A study in 11 young male subjects showed that significant tolerance occurs to restoril's thermoregulatory effects and sleep inducing properties after 1 week of use of 30 mg restoril. 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 restoril for 1–20 years was no different from that of controls. In an additional study in which at least one of the authors is employed by multiple drug companies examined the efficacy of restoril 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. The Journal of Clinical Sleep Medicine published a paper which had carried out a systematic review of the medical literature concerning insomnia medications and raised concerns about benzodiazepine receptor agonist drugs, the benzodiazepines and the Z-drugs that are used as hypnotics in humans. The review found that almost all trials of sleep disorders and drugs are sponsored by the pharmaceutical industry. It was found that the odds ratio for finding results favorable to industry in industry-sponsored trials was 3.6 times higher than non-industry-sponsored studies and that 24% of authors did not disclose being funded by the drug companies in their published paper when they were funded by the drug companies. The paper found that there is little research into hypnotics that is independent from the drug manufacturers. 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.

Physical dependence of Restoril

Restoril like other benzodiazepine drugs can cause physical dependence and addiction. Withdrawal from temazepam or other benzodiazepines after regular use often leads to a benzodiazepine withdrawal syndrome, which resembles symptoms during alcohol and barbiturate withdrawal. The higher the dose and the longer the drug is taken for, the greater the risk of experiencing unpleasant withdrawal symptoms. Withdrawal symptoms can also occur from standard dosages and after short term use. Abrupt withdrawal from therapeutic doses of Restoril after long term use may result in a severe benzodiazepine withdrawal syndrome. Gradual and careful reduction of the dosage, preferably with a long-acting benzodiazepine with long half life active metabolites such as chlordiazepoxide or diazepam is recommended, to prevent severe withdrawal syndromes from developing. Other hypnotic benzodiazepines are not recommended. There are rare reports in the medical literature of psychotic states developing after abrupt withdrawal from benzodiazepines, even from therapeutic doses. Antipsychotics increase the severity of benzodiazepine withdrawal effects with an increase in the intensity and severity of convulsions. Patients who were treated in the hospital with Restoril or nitrazepam have continued taking these after leaving the hospital. It was recommended that hypnotics in the hospital be limited to 5 nights use only, to avoid the development of withdrawal symptoms like insomnia.