Hypnotics: zopiclone, zolpidem, trazodone and tryptophan
Indication(s)
Zopiclone and sublingual zolpidem (oral disintegrating tablet, ODT- sublinox®): GABA agonists for short-term symptomatic relief of insomnia.
Trazodone: symptomatic relief of depression
Tryptophan: essential seratonergic amino acid for adjunctive treatment of bipolar affective disorders
Formulary status
The Drug Advisory Committee recommended that:
- Zopiclone and trazodone be listed on the burn (05WS), cancer (19WS) and psychotraumatic (22WS) formularies,
- Tryptophan not be listed as a hypnotic on any WSIB formulary - it should continue to be listed on Psychotraumatic (22WS) formulary for the treatment of psychiatric disorders;
- and zolpidem ODT not be listed on any WSIB formulary.
WSIB accepts the DAC recommendation for listing.
Recommendation highlights
- External, independent reviews of randomized, controlled trials, systematic reviews and meta-analyses show few meaningful differences in efficacy between zopiclone, zolpidem and benzodiazepines.
- Although there are several published RCTs for oral zolpidem, which is not available in Canada, there were no studies comparing sublingual zolpidem against treatments for insomnia available in Canada
- Due to potential for dependence, complex sleep behaviours and next-day psychomotor impairment, zopiclone and zolpidem should only be used short-term.
- Trazodone possesses sedative and antidepressant properties. It is associated with a lower risk of dependence and abuse.
- No rigorous evidence supporting the use of tryptophan in insomnia was located.
- Information on the efficacy of hypnotics to improve sleep parameters or increase productivity or functional ability in setting of work-related injury is unavailable.
- Current guidelines suggest use of hypnotics only after non-pharmacologic measures have been considered. Methodological issues limit the studies available to guide the choice of hypnotic.
- No pharmacoeconomic studies assessing the use of hypnotics were located. The Ontario Drug Benefit Program funds trazodone as general benefit and zopiclone under Exceptional Access Program. Zolpidem ODT (sublinox®) and tryptophan are not covered. Zolpidem ODT is more costly than zopiclone, trazodone, tryptophan and benzodiazepines.
- The DAC concluded that: (i) zopiclone and trazodone may be useful in the short-term treatment of insomnia; and (ii) tryptophan and zolpidem ODT lack rigorous evidence for use in insomnia.
Drug profile
Products available in Canada:
- Trazodone - desyrel®, various generics
- Trypthophan – various generics
- Zopiclone- imovane®, various generics
- Zolpidem - sublinox®, various generics
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