Natural health products (herbals) and over-the-counter sleep aids

Pharmacological Management of PRIMARY Insomnia (May 2009) - Prescription Products

sedative dose
effect on sleep / efficacy
-adverse effect: may cause bitter, metallic aftertaste (3 to 6% of patients) all BzRAs: residual daytime sedation, cognitive impairment, motor incoordination, dizziness. Also risk of tolerance, withdrawal, rebound not recommended:
-non-BzRAs ↑ total sleep time -in Canada, only the following BZDs have an official indication for the treatment of insomnia: temazepam, triazolam, nitrazepam, and flurazepam -BZDs that are not recommended for 1º insomnia:
triazolam- associated with rebound anxiety flurazepam & nitrazepam- accumulation/hangover, confusion oxazepam, lorazepam & clonazepam - limited evidence in 1º insomnia
Note: barbiturates & chloral hydrate are not recommended due to development of rapid tolerance and serious side effects.12
sedative dose
effect on sleep / efficacy
4-7.5 -amitriptyline and mirtazapine have not been -mirtazapine and amitriptyline are not recommended due to not recommended:
lack of evidence in 1º insomnia and significant adverse -in 1º insomnia, a trazodone RCT11 showed -trazodone is not considered 1st line therapy for 1º insomnia duration during 1st week of treatment only; because of limited evidence in this patient population another study12 found subjective improvement -RCTs in 1º insomnia include doxepin & trimipramine; in sleep quality but no ↓ in SOL or duration effective but not recommended due to adverse effects -improvements in sleep latency have been -systematic evidence supporting its use is very limited15 and therefore is not considered 1st line therapy for 1º insomnia -watch for serotonin syndrome especially if used with SSRI -evidence for efficacy in chronic 1º insomnia -not recommended for treatment of 1º insomnia -significant side effects including: weight gain, metabolic Products not currently available in Canada: ramelteon (Rozerem: melatonin receptor agonist), eszopiclone (Lunesta), zaleplon (Sonata/Starnoc), zolpidem (Ambien)

Clinical Perspectives:
Evidence supports BzRAs as the drug class of choice for 1º insomnia.10 Efficacy is comparable among the agents in this class for short-term treatment.7-9
Consistent differences between the drugs in this class have not been found with regards to incidence of short-term adverse effects.6,7,15-18 Clinical experiences, attitudes, and individual
patient responses to different medications within this class can vary greatly. BZD abuse and over-prescribing are recognized concerns; as such,
many sleep specialists recommend the non-BZDs (e.g zopiclone) as first line therapy over the BZDs.
Helpful opinions on comorbid insomnias: if daytime anxiety, restless leg syndrome, parasomnias: clonazepam may benefit insomnia; if neuropathic pain: amitriptyline/nortriptyline
may benefit insomnia; trazodone may be considered for insomnia when there are features of depression and/or anxiety; in resistant cases with significant mood and/or anxiety present
where different drugs have been tried and failed, quetiapine may be an option.
SOL=sleep onset latency, hs=bedtime, BZD=benzodiazepine, 1º =primary, RCTs =randomized controlled trials, t ½=half life, tx=treatment. References available upon request.

Pharmacological Management of PRIMARY Insomnia (May 2009) - Non-Prescription Products

Practice point: Use of non-prescription treatments for insomnia is not recommended, as this practice is not supported by rigorous data. Systematic efficacy and
safety data for most non-prescription products is very limited to short-term, small scale studies.19

generic name
also known as
usual dose
effect on sleep / efficacy
-variable, insufficient evidence on efficacy; -most clinical trials are short duration and small populations there is no consistent, statistically significant (i.e. < 14 days and < 25 patients enrolled) -generally well tolerated ; unlikely hangover effect -↓self-reported SOL (stat. significance varies) -case reports of hepatotoxicity in patients taking -subjective trial outcome measures suggest combination products with valerian (not clear if valerian possibly effective in improving sleep quality was the cause; if patient is taking long-term may want to -potential for a benzodiazepine-like withdrawal if discontinued suddenly; should be tapered if used long-term -subjective trial outcome measures suggest it -doses of 0.5 mg to 5 mg similarly effective for jet lag; is effective in prevention / reduction of jet lag doses >5mg did not appear to be more effective -evidence for efficacy in circadian rhythm -for jet lag, likely most effective for adults travelling across disorders, but only a modest decrease in SOL that is not felt to be clinically significant in -daytime drowsiness is common; both hypnotic and -may improve quality of sleep in elderly † Natural health products that are licensed by Health Canada can be identified by an eight digit NPN (natural product number). The issuance of a product license means that the product has been assessed by Health Canada and has
been found to be safe, effective and of high quality under its recommended conditions of use.
‡ Dosing of herbal preparations is highly dependent on a variety of factors, such as growing and harvesting conditions, plant parts and extraction methods used and the dosage form chosen by the manufacturer. For specific dosage
recommendations, the product label should be followed.

generic name
also known as
usual dose
effect on sleep / efficacy
-objective efficacy for treatment of insomnia is not well established; limited data to support -potential for serious side effects arising from that antihistamines either prolong or improve anticholinergic properties (especially in elderly); residual daytime sleepiness, diminished cognitive function, dry -subjective, self-reports suggest that these mouth, blurred vision, constipation, urinary retention, etc… not approved in
agents help patients to fall asleep, increase -these products are not intended for long-term use and Canada as a
sleep duration and improve quality of sleep tolerance to sedative effects likely develops rapidly (3 days) sleep aid
SOL=sleep onset latency, hs=bedtime, BZD=benzodiazepine, 1º =primary, RCTs =randomized controlled trials, t ½=half life, tx=treatment. References available upon request.
SOL=sleep onset latency, hs=bedtime, BZD=benzodiazepine, 1º =primary, RCTs =randomized controlled trials, t ½=half life, tx=treatment. References available upon request.



Schaltvorgänge der Transkription Friedrich-Alexander-Universität Erlangen-Nürnberg International Symposium Molecular Control of Gene Expression Invited speakers: Walter Birchmeier Berlin, Germany Richard G. Brennan Portland, USA Martin Eilers Marburg, Germany Roger D. Everett Glasgow, UK Hiroshi Handa Yokohama, Japan Wolfg

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