Published: September 2012

Hypnotics: No Time to be Weary

Prescriber Update 33(3): 29
September 2012

Healthcare professionals are reminded of the importance of appropriate use of hypnotics and to only prescribe these medicines for short periods.

The Medicines Adverse Reactions Committee (MARC) recently reviewed the potential association between use of hypnotics and an increased risk of mortality. This review was prompted by a paper published in the BMJ Open earlier this year1. The MARC agreed that the study had significant limitations and that the current data are inadequate to determine whether the association is causal.

The BMJ Open study concluded that patients prescribed any hypnotic had an increased risk of dying compared with patients who had never been prescribed hypnotics1. The authors concluded that there was a dose response as the risk of dying increased with the amount of hypnotics prescribed.

After exclusions, approximately 10,500 hypnotic users and 23,600 matched non-user controls were included in the study. The researchers concluded that patients with prescriptions for hypnotics had approximately 4.6 times the hazard of dying than non-users of hypnotics over an average observation period of two and a half years.

The results of the study are restricted by several significant limitations. There was no data on the cause of death in the study, which prevents an assessment of a causal association between hypnotic use and death. The study controlled for various co-morbidities. However, disease severity was not measured or controlled for. Importantly, psychiatric diagnoses were not available and were not controlled for. The study was conducted in a single US state that is predominantly rural and of low socioeconomic status. It is therefore not clear if the findings can be extrapolated to the greater population.

The MARC considered that the relationship between sleep disturbance and the development of medical and psychiatric conditions, including death, is highly complex and not well understood. The MARC agreed that more studies were needed in order to determine the risk of mortality in association with both sleep disturbance generally and with the use of hypnotics.

Further information about managing insomnia has been published by the Best Practice Advocacy Centre (BPAC)2.

Key Reminders

  • Hypnotics should only be used for short periods (ie, two to four weeks) for the treatment of severe or disabling insomnia. Continuous or long term use is not recommended.
  • The lowest effective dose of hypnotic should be used.
  • Avoid or use hypnotics with caution in patients with a history of substance abuse, myasthenia gravis, respiratory impairment or acute cerebrovascular accident.
  • Review patients for adverse effects — in particular, daytime sleepiness.
  • Give advice about the increased risk of use when prescribing for older patients and enquire about difficulties with balance, which may indicate an increased susceptibility to falls.
  1. Kripke DF, Langer RD, Kline LE. 2012. Hypnotics' association with mortality or cancer: a matched cohort study. BMJ Open 2: e000850.
  2. Best Practice Advocacy Centre. 2008. Managing insomnia. Best Practice Journal 14: 6-11. URL: