- Diagnosis of restless legs syndrome with a total score of 15 or more points on the
International RLS rating scale (IRLS).
- RLS symptoms interfering with sleep on 3 or more nights per week for at least 6
- PSG confirmation of WASO of at least 60 min, PLMI of 10 or more, and total sleep time
of at least 3 hrs and less than 6.5 hrs.
- Secondary RLS.
- Daytime RLS symptoms requiring treatment.
- Primary sleep disorder.
- Sleep apnea.
- Night or shift work.
- Concurrent medical disorder that could interfere with efficacy assessment or present
a safety concern.
- Pregnant or lactating women.
- Women of child-bearing potential not using acceptable method of birth control.
- Use of prohibited medication.