Melatonin Against Temazepam in Comparing adverse events in vulnerable elderly Hospitalized patients with sleeping problems

Sleep problems are common among acutely hospitalized older patients. They can
lead to patient distress and delayed recovery
from acute illness or surgical procedure. Often, a pharmacological treatment
approach is chosen, mostly with the benzodiazepine
temazepam. This treatment is not evidence based for this indication and
specific population. Older patients, who often have
multimorbidity and polypharmacy, are at increased risk of experiencing adverse
drug events. Benzodiazepines are among the
drugs most frequently associated with inhospital complications such as falls,
fractures, daytime hangover, delirium and respiratory
depression. Melatonin is an endogenous hypnotic and might be a safer
alternative for the treatment of sleep problems experienced
by acutely hospitalized older patients.

Primary objective: To investigate whether either melatonin or temazepam is
superior to placebo in improving subjective sleep quality and to investigate
whether melatonin is non-inferior to temazepam in acute hospitalized older
patients.
Secondary objectives:
To investigate whether melatonin or temazepam is superior to placebo and to
investigate whether melatonin is non-inferior to temazepam in:
- improving additional subjective sleepparameters: getting to sleep (GTS),
awakening from sleep (AFS) and behaviour following, wakening (BFW)
- improving objective sleepparameters (sleep onset latency, number of wake
bouts, time awake after sleep onset, sleepiness during the day)
- shortterm cognitive measures (reaction time, recall)
- (reduction of) adverse drugreactions related to study medication
- (reduction of) hospital complications (delirium, aspiration, falls, length of
hospital stay, readmissions)
- (reduction of) mortality (during hospitalisation, at follow-up)

Multicentered, 3armed placebo controlled, randomized superiority trial.

Patients will be randomized to receive either 1mg melatonin, 10mg temazepam or
placebo ante noctem daily for a maximum of ten hospital days

Patients will receive either temazepam, melatonin or placebo. Melatonin in a
dosage of 1 milligram is not known to show any sideeffects
and is considered safe for use by older patients. Consequently, the risks
associated with this intervention are considered
low. Temazepam has potential sideeffects
but as this medication is currently often part of the usual treatment of
hospitalized
elderly with sleep problems, participation in the study will not expose
patients to any extra additional risks. Close monitoring of all
possible adverse events related to study medication will take place, and in
case any adverse events occur, appropriate measures
will be taken in consultation with the attending physician. We do not think
that patients who are treated with placebo will be
exposed to any additional burden when use of benzodiazepines is withheld from
them, because evidence for the effectiveness of
pharmacological treatment for hospital related sleep problems is absent. All
patients will benefit from increased attention to sleep
problems.