ProHealth health Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

10 Fibro-Friendly Foods with a Bonus: Beautiful Skin

Studies Show that Magnesium L-threonate Improves Brain Plasticity, Leading to Direct and Significant...

Clary Sage Oil May Be Pricey, but Its Benefits Are Priceless

Pumpkin Pie Turmeric Breakfast Smoothie - Vegan + Gluten-Free

Component of red wine, grapes can help to reduce inflammation, study finds

Poly MVA: A Novel Therapy for Increasing Energy, Repairing DNA, and Promoting Overall Health

Vitamin D supplementation extends life in mouse model of Huntington's disease

Omega-3 fatty acid stops known trigger of lupus

Conquer Your Email Inbox, Increase Productivity and Reduce Stress

The Significance of Selenium

Print Page
Email Article

Nightly treatment of primary insomnia with prolonged release melatonin for 6 months: A randomized placebo controlled trial on age and endogenous melatonin as predictors of efficacy and safety – Source: BMC Medicine, Aug 16, 2010

  [ 14 votes ]   [ Discuss This Article ]
By Alan G Wade, et al. • • August 20, 2010

[Note: To read the full text of this article free, click HERE.]

Background: Melatonin [in regular and timed release form] is extensively used in the USA in a non-regulated manner for sleep disorders.

Prolonged release melatonin (PRM) is licensed in Europe and other countries for the short term treatment of primary insomnia in patients aged 55 years and over.

However, a clear definition of the target patient population and well-controlled studies of long-term efficacy and safety are lacking. It is known that melatonin production declines with age. Some young insomnia patients also may have low melatonin levels.

The study investigated:

• Whether older age or low melatonin excretion is a better predictor of response to PRM,

• Whether the efficacy observed in short-term studies is sustained during continued treatment,

• And the long term safety of such treatment.

Methods: Adult outpatients (791, aged 18-80 years) with primary insomnia, were treated with placebo (2 weeks) and then randomized, double-blind to 3 weeks with PRM or placebo nightly.

PRM patients continued whereas placebo completers were re-randomized 1:1 to PRM or placebo for 26 weeks with 2 weeks of single-blind placebo run-out.

Main outcome measures were sleep latency derived from a sleep diary, Pittsburgh Sleep Quality Index (PSQI), Quality of Life (World Health Organzaton-5) Clinical Global Impression of Improvement (CGI-I) and adverse effects and vital signs recorded at each visit.

On the primary efficacy variable sleep latency:

• The effects of PRM (3 weeks) in patients with low endogenous melatonin (6-sulphatoxymelatonin [6-SMT] 8 g/night) regardless of age did not differ from the placebo,

• Whereas PRM significantly reduced sleep latency compared to the placebo in elderly patients regardless of melatonin levels (-19.1 versus -1.7 min; P=0.002).

• The effects on sleep latency - and additional sleep and daytime parameters that improved with PRM - were maintained or enhanced over the 6-month period with no signs of tolerance.

Most adverse events were mild in severity with no clinically relevant differences between PRM and placebo for any safety outcome.

• The results demonstrate short- and long-term efficacy and safety of PRM in elderly insomnia patients.

• Low melatonin production regardless of age is not useful in predicting responses to melatonin therapy in insomnia.

• The age cut-off for response warrants further investigation.

Source: BMC Medicine, Aug 16, 2010;8(1):51. PMID: 20712869, by Wade AG, Ford I, Crawford G, McConnachie A, Nir T, Laudon M, Zisapel N. CPS Research and Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK; Neurim Pharmaceuticals Ltd. and Department of Neurobiology, Faculty of Life Sciences, Tel Aviv University, Tel-Aviv, Israel. [Email:]

Post a Comment

Featured Products From the ProHealth Store
Ultra EPA  - Fish Oil Melatonin Sublingual Tablets Ultra ATP+, Double Strength

Looking for Vitamins, Herbs and Supplements?
Search the ProHealth Store for Hundreds of Natural Health Products

Article Comments

Be the first to comment on this article!

Post a Comment

Natural Pain Relief Supplements

Featured Products

Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength
Melatonin Sublingual Tablets Melatonin Sublingual Tablets
Supports Deep, Restful Sleep Naturally

Natural Remedies

Coconut Oil - Healthy Gifts from the 'Tree of Life' Coconut Oil - Healthy Gifts from the 'Tree of Life'
Irritable Bowel Syndrome: Unlocking the Secrets of Peppermint, Acacia and Fennel Irritable Bowel Syndrome: Unlocking the Secrets of Peppermint, Acacia and Fennel
Strengthen Cell Function with Energy-Boosting Niagen Strengthen Cell Function with Energy-Boosting Niagen
Rejuvenating the Brain - How PQQ Helps Power Up Mental Processing Rejuvenating the Brain - How PQQ Helps Power Up Mental Processing
Sunshine Vitamin Has D-lightful Health Benefits Sunshine Vitamin Has D-lightful Health Benefits

ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
Credit Card Processing
Be the first to know about new products, special discounts and the latest health news. *New subscribers only

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2016 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map