This is the current release of the guideline.

Restless legs syndrome (RLS) and periodic limb movement disorder (PLMD)

Assessment of Therapeutic Effectiveness
Treatment

Family Practice
Internal Medicine
Neurology
Sleep Medicine

Physicians

To serve as a guide for the appropriate use of dopaminergic agents in the treatment of restless legs syndrome (RLS) and periodic limb movement disorder (PLMD)

Patients with restless legs syndrome (RLS) and periodic limb movement disorder (PLMD)

• Therapeutic efficacy of dopaminergic agents for treatment of RLS and PLMD
• Sleep parameters (total sleep time, sleep efficiency)
• Restless legs syndrome (RLS) and periodic leg movement disorder (PLMD) symptoms
• Adverse effects
• Quality of life

Hand-searches of Published Literature (Primary Sources)
Searches of Electronic Databases

Literature searches were first conducted in January 2001, and then updated in August 2001 and finally, April 2002. The search was performed through Medline using the search terms: restless legs, periodic leg movement, periodic limb movement, and nocturnal myoclonus. A PubMed search was also done. Search terms were applied both to the keyword field and as a text search. A total of 227 papers were derived from the searches and reviewed for relevance to the therapeutic literature based on their abstracts. 56 papers were selected for detailed consideration and four were added by task force member recommendation from other search resources. Of these, 27 met the criteria of having a focus on restless legs syndrome (RLS) treatment with a minimum of 5 patients studied, a clear indication of restless legs syndrome or periodic limb movement disorder (PLMD) diagnosis for study entry, and use of a pharmaceutical agent which was primarily active on the dopamine system.

27 articles were identified

Weighting According to a Rating Scheme (Scheme Given)

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

Systematic Review with Evidence Tables

Not stated

Expert Consensus

In most cases, the conclusions are based on evidence from studies published in peer-reviewed journals that were evaluated as noted in the evidence tables of the companion review paper in the original guideline document. When scientific data are absent, insufficient, or inconclusive, the recommendations are based upon consensus opinion.

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.

A formal cost analysis was not performed and published cost analyses were not reviewed.

Internal Peer Review

These recommendations were developed by the Standards of Practice Committee and reviewed and approved by the Board of Directors of the American Academy of Sleep Medicine.

None provided

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

• Appropriate use of dopaminergic agents in the treatment of restless legs syndrome (RLS) and periodic limb movement disorder (PLMD)
• Relief of RLS and PLMD symptoms
• Reduction of PLMS and PLMS-Waking Index
• Improvement in sleep parameters

Levodopa with Decarboxylase Inhibitor

The main side effects complicating the use of this agent in clinical series are the high frequencies of restless legs syndrome (RLS) daytime augmentation (i.e., occurrence or worsening of daytime RLS symptoms with long-term medication usage, typically increased by higher doses) and early morning rebound of RLS symptoms, especially at higher dose levels.

Pergolide

Adverse effects include nausea, congestion, and mild augmentation. In most cases, these adverse effects were either minor or could be adequately controlled; however, the development of pleuropulmonary fibrosis or cardiac valvulopathy has been reported in isolated case reports.

Pramipexole

The most common reported side effects in these studies were fluid retention/edema, daytime fatigue/sleepiness, gastrointestinal distress, insomnia/alertness, dizziness, and occasional augmentation of RLS.

Amantadine

In one study, side effects of drowsiness and fatigue were reported.

• These practice parameters define principles of practice that should meet the needs of most patients in most situations. These guidelines should not, however, be considered inclusive of all proper methods of care or exclusive of other methods of care reasonably directed toward obtaining the same results. The ultimate judgment regarding the propriety of any specific care must be made by the physician in light of the individual circumstances presented by the patient and the available diagnostic and treatment options.
• These practice parameters reflect the state of knowledge at the time of development and will be reviewed, updated, and revised, as new information becomes available.

An implementation strategy was not provided.

Getting Better
Living with Illness

Effectiveness

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

2004 May 1

American Academy of Sleep Medicine - Professional Association

American Academy of Sleep Medicine

Standards of Practice Committee

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

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.

This is the current release of the guideline.

None available

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).

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.