5-HTP

What is it used for?

• Helps (to) promote healthy mood balance [Source note 2].

• Helps (to) relieve sleep disturbances associated with mood imbalance [Source note 3]

• Helps (to) relieve symptoms of fibromyalgia [Source note 4].

• Helps (to) reduce the severity and duration of migraine headaches when taken as a preventative (prophylactic) [Source note 5].

• To be used with a program of reduced intake of dietary calories and increased physical activity (if possible) to help in weight management by reducing carbohydrate cravings (Cangiano et al.1998; Cangiano et al. 1992; Ceci et al. 1989).

What this guide covers

• The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant on the label.

Who does this guide cover?

Adults 18 years and older

How is it taken?

Oral

Which forms are covered?

this reference excludes foods or food-like dosage forms as indicated in the Compendium of references Guidance Document.

Quantities

Healthy mood balance

150 - 300 milligrams of 5-HTP, per day [Source note 6].

Fibromyalgia symptoms

300 - 400 milligrams of 5-HTP, per day; Not to exceed 300 milligrams per single dose [Source note 7].

Migraine prophylaxis

200 - 600 milligrams of 5-HTP, per day; Not to exceed 300 milligrams per single dose [Source note 8].

Weight management

750 - 900 milligrams of 5-HTP, per day; Not to exceed 300 milligrams per single dose [Source note 9].

Sleep disturbances

100 - 200 milligrams of 5-HTP, per day [Source note 10].

How is it used?

All uses

To minimize the risk of gastrointestinal side effects, start at lower dose and slowly increase to effective dose over 2-week period [Source note 11].

All uses (excluding weight management)

Take with food [Source note 12].

Weight management

Take 30 minutes before meals [Source note 13].

How long is it used?

Healthy mood balance; Fibromyalgia symptoms; Migraine prophylaxis; Sleep disturbances

Use for at least 2 weeks to see beneficial effects [Source note 14].

Weight management (products providing over 600 mg 5-HTP, per day)

Ask a healthcare professional for use beyond 12 weeks [Source note 15].

Warnings and precautions

All uses

• Ask a healthcare professional before use if you are taking carbidopa or health products with serotonergic activity such as mood balance supplements, cough medication containing dextromethorphan, pain killers or medications for nausea or migraine [Source note 16].

• When using this product exercise caution while driving or using machinery, as you may experience drowsiness [Source note 17].

• Ask a healthcare professional if symptoms persist or worsen.

All uses (excluding weight management)

Ask a healthcare professional before use if you are pregnant or breastfeeding.

Weight management

Ask a healthcare professional before use if you are breastfeeding.

Healthy mood balance; Fibromyalgia symptoms

Ask a healthcare professional before use if you have a psychological disorder such as anxiety or depression.

When should it be avoided?

All uses

• Do not use if you have scleroderma [Source note 18].

• Do not use if you are taking antidepressants [Source note 19].

Weight management

Do not use if you are pregnant [Source note 20].

Possible side effects

• When using this product you may experience gastrointestinal discomfort/disturbances [Source note 21].

• Stop use and ask a healthcare professional if you experience skin hardening, pain or stiffness of muscles or joints, tremors, agitation/confusion, or an increased heart rate [Source note 22].

Storage

Must be established in accordance with the requirements described in the applicable product regulations.

Restrictions when this reference is combined with other references (source review category II and III):

• If a weight management claim is made:

  • Weight management is a long-term process and must therefore, be associated with a long-term intervention.

  • active ingredient with diuretic properties may be included in weight management products, however no diuretic claim can be applied as it is associated with a short-term duration of use (occasional use only).

  • Stimulant laxatives cannot be present at therapeutic dose in weight management products as their short term duration of use is not compatible with the duration of use for weight management.