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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.



February 25, 2019

Proper name(s), Common name(s), Source material(s)

Table 1. Proper name(s), Common name(s), Source material(s)
Proper name(s) Common name(s) Source material(s)
Proper name(s) Part(s) Preparation

Withania somnifera

  • Asgandh
  • Ashwagandha
  • Asvagandha
  • Winter-cherry
  • Withania

Withania somnifera



References: Proper name: USDA 2018; Common names: API 2001, McGuffin et al. 2000; Source material: API 2001.

Route of Administration

Oral (API 2001)

Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

The following combined use(s) or purpose(s) is/are also acceptable:

Traditionally used in Ayurveda as a sleep aid and to balance aggravated Vata (nervine) (Khare 2004; Kapoor 2001; Upton 2000; Khory and Katrak 1999; Nadkarni 1954.


Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".



Adults 18 years and older


Traditional Ayurvedic Claims

Methods of preparation: Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

2 - 6 grams of dried root, per day (Williamson 2002; API 2001; Kapoor 2001; Nadkarni 1954).


Methods of preparation: Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)

2.5 - 6.5 grams of dried root, per day (Winston and Maimes 2007; Bone 2003; Williamson 2002).

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Sleep Aid

Consult a health care practitioner/health care provider/health care professional/doctor/physician if sleeplessness persists for more than 4 weeks (chronic insomnia) (Berardi et al. 2002; Dipiro et al. 2002).

All Uses


No statement required.

Known adverse reaction(s)

Some people may experience drowsiness. Exercise caution if operating heavy machinery, driving a motor vehicle or involved in activities requiring mental alertness (Berardi et al. 2002).

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

No statement required.


References Cited