Up to 40% of patients with insomnia will have ongoing symptoms despite cognitive behavioural therapy.22,23 If drug therapy is considered, it is important to evaluate the underlying nature of the patient’s insomnia and what the intended outcome of prescribing is.
Acute insomnia
Short‑term drug therapy may be appropriate in acute insomnia with an identifiable precipitating stressor, illness or circumstances, in order to prevent progression to chronic insomnia. This would generally be of short duration, up to four weeks, while in parallel working on addressing the acute precipitating circumstances.
Chronic insomnia
In patients with chronic insomnia and high levels of distress, using a drug as an adjunct to cognitive behavioural therapy can be helpful to provide predictability with sleep and prevent escalation of sleep‑related anxiety. In a trial of 160 adults with chronic insomnia, patients were randomised to receive cognitive behavioural therapy alone, or in conjunction with zolpidem for the first six weeks. The group that had combined therapy for six weeks, then cognitive behavioural therapy alone during six months of extended therapy, had the best outcomes with remission rates of 68% at six months.22 This study demonstrated the importance of addressing distress associated with insomnia early in treatment (first six weeks in this study), while people are working through cognitive behavioural therapy and increasing their skills and confidence in the cognitive and behavioural strategies. However, when prescribing any medicine in chronic insomnia it should be discussed with patients that the medicine is only intended as being short term as effects generally reduce over time.
Melatonin (2 mg extended‑release formulation) is effective in treating insomnia in adults over the age of 55 over a three‑week period.24 It may also be useful in patients with a circadian rhythm disturbance, resulting in sleep onset insomnia or early morning awakening.24,25 However, there is little evidence to guide formulation, dose and duration of therapy when used outside of melatonin’s registered indication of insomnia in adults over the age of 55 years.
Suvorexant, a dual orexin receptor antagonist, can be an effective treatment in sleep maintenance insomnia due to hyperarousal. It can improve sleep latency, sleep maintenance and total sleep time compared to placebo.23,26
Benzodiazepines and benzodiazepine receptor agonists, including zolpidem and zopiclone, are effective short‑term therapies for sleep onset and sleep maintenance insomnia. Data on long‑term efficacy are limited.23,27
There is a risk of drug dependency, tolerance and abuse, but limiting dose escalation and regular monitoring are likely to mitigate this risk.23 When prescribing these drugs for insomnia, a harm–benefit assessment should be undertaken, with particular care in the elderly population. Sleep‑promoting medicines can interact with other drugs that cause sedation, including alcohol, and should be used cautiously in these circumstances. Hypnotic drugs may increase the risk of falls, but so does a lack of sleep.
Despite a lack of evidence, antidepressants, sedating antipsychotics and antihistamines are often prescribed for the treatment of insomnia despite having significant potential adverse effects.28‑30 These drugs are not recommended because of this limited evidence and their adverse effects.23
Stopping drugs
Benzodiazepines and benzodiazepine receptor agonists are only recommended for short‑term use, up to four weeks, so a strategy for their safe withdrawal is required. In a systematic review and meta‑analysis, combining cognitive behavioural therapy with gradual tapering of the drugs over three months was more effective for stopping the drugs than gradual tapering alone. The combination was associated with short‑term improvement in the symptoms of insomnia.31