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Brief Summary

GUIDELINE TITLE

Practice parameters for the dopaminergic treatment of restless legs syndrome and periodic limb movement disorder.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • March 29, 2007, Permax (pergolide): Voluntary market withdrawal in the U.S. and worldwide due to safety concerns of an increased risk of cardiovascular events. See the U.S. Food and Drug Administration (FDA) Web site for more information.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Levels of recommendation (Standard, Guideline, and Option) and levels of evidence (I-V) are defined at the end of the "Major Recommendations" field.

  1. Levodopa with decarboxylase inhibitor is effective in the treatment of restless legs syndrome (RLS) and periodic limb movement disorder (PLMD). (Hening et al., 2004; 4.b; Table 3) (Standard)
  2. The dopamine agonist pergolide* is effective in the treatment of RLS and PLMD. (Hening et al., 2004; 4.c.ii; Table 4) (Standard)
  3. The dopamine agonist pramipexole is effective in the treatment of RLS and PLMD. (Hening et al., 2004; 4.c.iii; Table 4) (Guideline)
  4. The dopamine agonist ropinirole is effective in the treatment of RLS and PLMD. (Hening et al., 2004; 4.c.iv; Table 4) (Option)
  5. Other dopamine agonists (talipexole, cabergoline, piribedil, and alpha-dihydroergocryptine) may be effective in the treatment of RLS or PLMD, but the level of effectiveness of these agonists is not currently established. (Hening et al., 2004; 4.c.v; Table 4) (Option)
  6. The dopaminergic agents amantadine and selegiline may be effective in the treatment of RLS and PLMD, but the level of effectiveness of these agents is not currently established. (Hening et al., 2004; 4.d; Table 5) (Option)
  7. No specific recommendations can be made regarding dopaminergic treatment of children or pregnant women with RLS or PLMD. (Hening et al., 2004; 5.b)

*Note from the National Guideline Clearinghouse (NGC): On March 29, 2007, Permax (pergolide) was withdrawn from the market in the U.S. and worldwide due to safety concerns of an increased risk of cardiovascular events. See the U.S. Food and Drug Administration (FDA) Web site for more information.

Definitions:

Levels of Recommendation

Standard: This is a generally accepted patient-care strategy, which reflects a high degree of clinical certainty. The term standard generally implies the use of Level I Evidence, which directly addresses the clinical issue, or overwhelming Level II Evidence.

Guideline: This is a patient-care strategy, which reflects a moderate degree of clinical certainty. The term guideline implies the use of Level II Evidence or a consensus of Level III Evidence.

Option: This is a patient-care strategy, which reflects uncertain clinical use. The term option implies either inconclusive or conflicting evidence or conflicting expert opinion.

Levels of Evidence

Level I (Grade A Recommendation): Large, well-designed, randomized, and blinded controlled study with statistically significant conclusions on relevant variables

Level II (Grade B Recommendation): Smaller, well-designed, randomized, and blinded controlled study with statistically significant conclusions on relevant variables

Level III (Grade C Recommendation): Well-designed, non-randomized prospective study with control group

Level IV (Grade C Recommendation): Well-designed, large prospective study with historical controls or careful attention to confounding effects or small prospective study with control group

Level V (Grade C Recommendation): Small prospective study or case series without control groups

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

REFERENCES SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence is specifically stated for each recommendation (See "Major Recommendations" field).

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2004 May 1

GUIDELINE DEVELOPER(S)

American Academy of Sleep Medicine - Professional Association

SOURCE(S) OF FUNDING

American Academy of Sleep Medicine

GUIDELINE COMMITTEE

Standards of Practice Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Committee Members: Michael R. Littner, MD, VA Greater Los Angeles Healthcare System and David Geffen School of Medicine at UCLA, Sepulveda, CA; Clete Kushida, MD, PhD, Stanford University Center of Excellence for Sleep Disorders, Stanford, CA; W. McDowell Anderson, MD, College of Medicine, University of South Florida, Tampa, FL; Dennis Bailey, DDS, Englewood, Colorado; Richard B. Berry, MD, Malcom Randall VAMC/Univ. of Florida-Gainesville,Fla; Max Hirshkowitz, PhD, Baylor College of Medicine and VA Medical Center, Houston, TX; Sheldon Kapen, MD, VA Medical Center and Wayne State University, Detroit, MI; Milton Kramer, MD, Maimoides Medical Center, Psychiatry Department, Brooklyn, NY and New York University School of Medicine, New York, NY; Teofilo Lee-Chiong, MD, National Jewish Medical and Research Center, Sleep Clinic, Denver, CO; Kasey K. Li, DDS, MD, Stanford Sleep Disorders Clinic and Research Center; Daniel L. Loube, MD, Sleep Medicine Institute, Swedish Medical Center, Seattle, WA; Timothy Morgenthaler, MD, Mayo Sleep Disorders Center, Mayo Clinic, Rochester, MN; Merrill Wise, MD, Departments of Pediatrics and Neurology, Baylor College of Medicine, Houston, TX

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

All authors of the accompanying review paper, members of the Standards of Practice Committee, and the American Academy of Sleep Medicine (AASM) Board of Directors completed detailed conflict-of-interest statements and were found to have none with regard to this subject.

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the American Academy of Sleep Medicine (AASM) Web site.

Print copies: Available from the Standards of Practice Committee, American Academy of Sleep Medicine, One Westbrook Corporate Center, Suite 920, Westchester, IL 60154. Web site: www.aasmnet.org.

AVAILABILITY OF COMPANION DOCUMENTS

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI on May 2, 2005. The information was verified by the guideline developer on June 2, 2005. This summary was updated by ECRI Institute on May 8, 2007 following the U.S. Food and Drug Administration market withdrawal of Permax (pergolide).

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. Please contact the American Academy of Sleep Medicine (AASM) for information regarding reproduction of AASM guidelines.

DISCLAIMER

NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities.

Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusion.aspx .

NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes.

Readers with questions regarding guideline content are directed to contact the guideline developer.


 

 

   
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