Between February and May 2020, more than eight hundred patients took part in an online survey on the use of benzodiazepines and related drugs for sleep disorders. Most patients report longer use than recommended and more than one out of three patients show signs of psychological dependence on the treatment.
Sleep disorders, especially insomnia, are very common in the population. Non-pharmacological alternatives (other than drugs) are recommended as first line treatment of chronic insomnia in adults. However, many patients prefer sleeping drugs as treatment because they give quick results.
Benzodiazepines and related drugs are the most commonly used medicines for insomnia. Those medicines are considered effective if they are used rationally, with a minimal dose and for a limited period (less than one month).
However, even when used correctly, those medicines present certain risks and some adverse reactions may appear: cognitive disorders, risks of falling, drowsiness by day, addiction or even dependence.
To gather facts on the use of such sleeping drugs by patients and to assess the misuse and the level of addiction to those medicines, the FAMHP carried out a survey among patients between February and May 2020.
This survey pointed out some worrying facts.
- Most patients have been using sleeping drugs for more than one year
92% of the patients are long-term users (use for one month or more) and 84% are very long-term users (use for six months or more).
Among elderly patients (65 years and over), 84% have been using a sleeping drug for more than one year, compared to 72% in younger age groups.
80% of the patients mention a daily or regular use (at least once a week) in the long term and 73% mention a daily or regular use in the very long term.
Therefore, most patients are in a situation of misuse. - Signs of psychological dependence on the treatment for more than one patient out of three
Based on the Severity of Dependence Scale (SDS)1, 38% of the patients show signs of psychological dependence on their treatment. This applies to 43% of males and 36% of females. There are no significant differences between age groups.
Besides, 75% of the patients wished to stop their treatment, 67% tried to stop and 46% would find it very difficult or even impossible to stop.
However, 40% of the patients never worried about their use of sleeping drugs. - Most patients have tried alternative methods
More than 60% of the patients have tried the following alternative methods: sleep hygiene, herbal therapy (plant-based medicines), homeopathy or food supplements.
A therapy or support from close relations were mentioned by almost 20% of the patients. - Zolpidem as major sleeping drug
Almost one out of two patients (48%) uses zolpidem as a sleeping drug. Lormetazepam (23%) and lorzepam (12%) are the only other products mentioned by more than 10% of the patients. - Concern about daily dose for some patients
Although only a minority of patients (16%) use a higher dose than recommended, 5% report taking more than twice the recommended dose. Besides, two users of zolpidem and one user of zopiclone declared using a daily dose more than ten times higher than recommended.
A higher percentage of people using doses higher than recommended is observed among younger age groups (< 65 years): 17% compared to 12% for patients aged 65 or over.
More males than females declare using higher doses than recommended: 23% compared to 12%.
Conclusions
Even though the results of this survey cannot be extrapolated to the whole population using those drugs, they obviously point out some issues for which a special attention is required. Indeed, the survey shows that guidelines on the duration of the treatment are observed neither by the patients, nor by the health care professionals who keep on prescribing such medicines in the long term. Still, chronic use is not advisable because of the increased risk of tolerance, addiction and misuse.
Moreover, the results are compliant with observations made in other countries on the tendency to prescribe 'z-drugs' (especially zolpidem) instead of benzodiazepines. Several studies2 showed that many health care professionals still consider 'z-drugs' to be more effective and safer than benzodiazepines. However, there is no convincing evidence up to now that those products cause less adverse reactions or less addiction.
The FAMHP recalls that benzodiazepines and 'z-drugs' may induce i.a. nervous system disorders (drowsiness, anterograde amnesia ...), psychiatric disorders (strange behaviour, hallucinations, sleepwalking ...) and increase the risk of falling in elderly people.
How to prevent misuse and dependence?
The FAMHP urges health care professionals to discuss those risks with their patients before prescribing such a sleeping drug. The FAMHP also advises to schedule a follow-up consultation after one week to discuss the effectiveness of the treatment and the possible adverse reactions with the patient.
By prescribing smaller boxes (less than 30 pills) of benzodiazepines or related drugs, health care professionals also encourage patients to consult once again if they feel the need to continue the treatment.
The FAMHP recalls that an online help manual was developed in 2018 within the campaign 'Somnifères & calmants, pensez d’abord aux autres solutions' (Sleeping pills and sedatives, think of other solutions first) coordinated by the FPS Health, Food Chain Safety and Environment. The aim of this manual is to help doctors and pharmacists provide better care to patients complaining about sleep problems.
Healthcare professionals can also refer to the evidence-based guideline 'First-line treatment of sleep disorders and insomnia in adults' and to the 'Fiche de transparence de la prise en charge de l'insomnie' (Transparency file on the treatment of insomnia).
Deprescribing sleeping drugs should be envisaged for all chronic users, especially when aged 65 years or over. The survey showed that most patients are in favour of stopping the treatment. The help manual provides tools to help patients interrupt their treatment.
Finally, the FAMHP also recalls that the legislation on pharmacovigilance encourages the notification of cases of misuse and dependence on medicines. The definition of the concept of adverse reaction has been extended to include noxious and unintended reactions resulting from the use of a medicine beyond the provisions of the marketing authorisation, for instance due to misuse.
More about the survey of the FAMHP
The FAMHP carried out the survey from February to May 2020. The main purpose of this survey was to gather facts on the use of benzodiazepines and related drugs by patients living outside an institution in case of sleep disorders. The FAMHP also wanted to assess the misuse and the dependence level to such medicines. Patients living outside an institution and aged eighteen years or over, using at least one of the medicines concerned, were invited to take part in the survey by their dispensary pharmacist or through several communication channels, voluntarily and anonymously.
In total, 808 patients responded to the survey and the main analysis is based on 466 complete answers. The average age of the respondents is 55 years and 63% are females. Only 8 patients in the youngest age group (18-24 years) took part in the survey.
The FAMHP thanks the patients who took part in the survey, as well as the dispensary pharmacists and the several partners who cooperated in this.
1 De Las Cuevas, C., Sanz, E. J., De La Fuente, J. A., Padilla, J. & Berenguer, J. C. The Severity of Dependence Scale (SDS) as screening test for benzodiazepine dependence: SDS validation study. Addiction 95, 245–250 (2003).
2 Heinemann, S., Brockmöller, J., Hagmayer, Y. et al. Why Z-drugs are used even if doctors and nurses feel unable to judge their benefits and risks—a hospital survey. Eur J Clin Pharmacol 76, (2020): 285–290 https://doi.org/10.1007/s00228-019-02783-1
Hoffmann F., Perceptions of German GPs on benefits and risks of benzodiazepines and Z-drugs. Swiss Med Weekly 143 (2013):w13745. https://doi.org/10.4414/smw.2013.13745
Siriwardena A.N., Qureshi Z., Gibson S., Collier S., Latham M., GPs' attitudes to benzodiazepine and 'Z-drug' prescribing: a barrier to implementation of evidence and guidance on hypnotics. Br J Gen Pract.56, 533 (2006):964-967.