Medication | Starting dose | Usual effective dose range | Common side effects | Rare but serious side effects |
Sodium oxybate immediate-release¶ | Doses are administered twice nightly, at bedtime and 2.5 to 4 hours later Recommended starting dose by weight:
| 2 to 9 grams in 2 divided doses at night Maximum recommended total night dose by weight:
| Morning sedation, nausea, weight loss, dizziness, enuresis, sleepwalking, tremor, worsening of OSA | Confusion, severe sedation, central sleep apnea, coma, diversion or misuse¶ |
Sodium oxybate extended-release¶ | 4.5 grams at bedtimeΔ | 4.5 to 9 grams at bedtime Maximum recommended daily dose by weight:
| Same as for sodium oxybate immediate-release | Same as for sodium oxybate immediate-release |
Mixed-salt oxybate (calcium, magnesium, potassium, and sodium oxybates)¶ | Same as for sodium oxybate immediate-release | Same as for sodium oxybate immediate-release | Same as for sodium oxybate immediate-release | Same as for sodium oxybate immediate-release |
Pitolisant◊ | By weight:
| By weight:
| Headache, insomnia, nausea, anxiety | Severe rash, QT prolongation |
Tricyclic antidepressants | ||||
Clomipramine§ | 25 mg at bedtime | 25 to 100 mg/day at bedtime | Dry mouth, constipation, sweating, blurry vision, somnolence, weight gain, orthostatic hypotension | Cardiotoxicity, seizures, suicidal ideation, bone marrow suppression, serotonin syndrome |
Imipramine | 25 mg once daily | 25 to 75 mg/day in 1 to 2 divided doses | ||
Protriptyline§ | 5 mg once daily | 5 to 10 mg/day in 1 to 2 divided doses | ||
Selective serotonin reuptake inhibitors | ||||
Fluoxetine | 5 to 10 mg once daily | 10 to 30 mg once daily | Nausea, insomnia, tremor | Suicidal ideation, prolongation of QT interval, serotonin syndrome |
Sertraline | 12.5 to 25 mg once daily | 25 to 200 mg once daily | ||
Citalopram | 10 mg once daily | 10 to 40 mg once daily | ||
Serotonin norepinephrine reuptake inhibitors | ||||
Venlafaxine | 25 mg once daily | 37.5 to 75 mg once daily | Nausea, weight loss, dizziness, headache, constipation, insomnia, somnolence, tremor | Suicidal ideation, prolongation of QT interval, serotonin syndrome |
OSA: obstructive sleep apnea.
* Doses listed in table are appropriate for children ≥6 years and adolescents (except as noted).
¶ Dosing shown for children ≥7 years and adolescents; guidance for such children weighing <20 kg is provided in drug information included within UpToDate. In the United States, prescribers must register with the Risk Evaluation and Mitigation Strategies (REMS) program and follow specific safety and monitoring recommendations. Combined use with alcohol, sedatives, or hypnotics is specifically contraindicated in United States licensing information.
Δ If there is concern that a starting dose of 4.5 grams is too high for a patient, we advise starting with immediate-release sodium oxybate, which allows for lower and more flexible titration. As an example, the immediate-release formulation is recommended for children weighing <45 kg until the total nightly dose is ≥4.5 grams.
◊ Dosing is expressed as pitolisant base and corresponds with tablet strengths available in the United States. International products may express dosing differently (eg, as pitolisant hydrochloride or approximate pitolisant base amount) depending on country. Refer to local product information.
§ Dosing shown for children ≥10 years and adolescents.