Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.

"Patient with a diagnostic of idiopathic hypersomnia (ICSD-3 criteria) will be randomized to receive solriamfetol or placebo for 7 weeks of treatment period. For the experimental arm, the dose will be progressively increased beginning at 75 mg to 300 mg according to tolerance to treatment.~Solriamfetol will be taken once a day upon awakening Schema of dispensation~1. One tablet of solriamfetol 75 mg per day for 1 week (week 1)~2. 150 mg of solriamfetol per day for 2 weeks (weeks 2 and 3)~3. According clinical judgment, Dose either maintained stable at 150 mg or increased to 300 mg per day for 2 weeks (weeks 4 and 5).~4. Prescription at week 5: Dose maintained at 150 or 300 mg or reduced at 150 mg per day according to benefit and safety for 2 weeks.~Treatment duration: 7 weeks treatment period."

"Patient with a diagnostic of idiopathic hypersomnia (ICSD-3 criteria) will be randomized to receive solriamfetol or placebo for 7 weeks of treatment period.~Placebo will be taken once a day upon awakening Schema of dispensation~1. One tablet of placebo per day for 1 week (week 1)~2. Two tablets of placebo per day for 2 weeks (weeks 2 and 3)~3. According clinical judgment, Either maintained stable with 2 tablets or increased to 4 tablets per day for 2 weeks (weeks 4 and 5).~4. Prescription at week 5: Dose maintained at 2 or 4 tablets or reduced at 2 tablets per day according to benefit and safety for 2 weeks.~Treatment duration: 7 weeks placebo period."