Nonpharmacologic approaches to treating narcolepsy include general lifestyle measures and sleep hygiene (relatively strict sleep schedule; naps; and avoiding sleep deprivation, alcohol, smoking, and late-night exercise). Pharmacologic treatment is used to relieve excessive daytime sleepiness (EDS) and cataplexy.[93]Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021 Sep 1;17(9):1881-93.
https://jcsm.aasm.org/doi/10.5664/jcsm.9328
http://www.ncbi.nlm.nih.gov/pubmed/34743789?tool=bestpractice.com
[94]Bassetti CLA, Kallweit U, Vignatelli L, et al. European guideline and expert statements on the management of narcolepsy in adults and children. Eur J Neurol. 2021 Sep;28(9):2815-30.
https://onlinelibrary.wiley.com/doi/10.1111/ene.14888
http://www.ncbi.nlm.nih.gov/pubmed/34173695?tool=bestpractice.com
Patients with severe EDS are advised not to drive or take part in potentially dangerous activities at home or at work.[94]Bassetti CLA, Kallweit U, Vignatelli L, et al. European guideline and expert statements on the management of narcolepsy in adults and children. Eur J Neurol. 2021 Sep;28(9):2815-30.
https://onlinelibrary.wiley.com/doi/10.1111/ene.14888
http://www.ncbi.nlm.nih.gov/pubmed/34173695?tool=bestpractice.com
Nonpharmacologic treatment
Nonpharmacologic approaches include sleep hygiene, and ensuring regular and adequate amounts of sleep to minimize daytime sleepiness. Scheduled naps during the day aim to optimize daytime function; there is limited evidence of effectiveness, but the balance between desirable and undesirable effects is likely in favor of naps.[93]Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021 Sep 1;17(9):1881-93.
https://jcsm.aasm.org/doi/10.5664/jcsm.9328
http://www.ncbi.nlm.nih.gov/pubmed/34743789?tool=bestpractice.com
[94]Bassetti CLA, Kallweit U, Vignatelli L, et al. European guideline and expert statements on the management of narcolepsy in adults and children. Eur J Neurol. 2021 Sep;28(9):2815-30.
https://onlinelibrary.wiley.com/doi/10.1111/ene.14888
http://www.ncbi.nlm.nih.gov/pubmed/34173695?tool=bestpractice.com
[95]Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment. J Clin Sleep Med. 2021 Sep 1;17(9):1895-945.
https://jcsm.aasm.org/doi/10.5664/jcsm.9326
http://www.ncbi.nlm.nih.gov/pubmed/34743790?tool=bestpractice.com
It is advisable to avoid alcohol or central nervous system (CNS)-suppressant medications. Adequate psychosocial support is important.[93]Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021 Sep 1;17(9):1881-93.
https://jcsm.aasm.org/doi/10.5664/jcsm.9328
http://www.ncbi.nlm.nih.gov/pubmed/34743789?tool=bestpractice.com
[94]Bassetti CLA, Kallweit U, Vignatelli L, et al. European guideline and expert statements on the management of narcolepsy in adults and children. Eur J Neurol. 2021 Sep;28(9):2815-30.
https://onlinelibrary.wiley.com/doi/10.1111/ene.14888
http://www.ncbi.nlm.nih.gov/pubmed/34173695?tool=bestpractice.com
[96]Goswami M. The influence of clinical symptoms on quality of life in patients with narcolepsy. Neurology. 1998 Feb;50(2 suppl 1):S31-6.
http://www.ncbi.nlm.nih.gov/pubmed/9484421?tool=bestpractice.com
People with mild symptoms can be treated with nonpharmacologic therapy alone.
Treatment of EDS in adults
EDS is typically treated with CNS stimulants. First-line therapies include modafinil, pitolisant, sodium oxybate, or solriamfetol. Guidelines and meta-analysis conclude that the benefits of these agents outweigh the risks for patients with EDS.[93]Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021 Sep 1;17(9):1881-93.
https://jcsm.aasm.org/doi/10.5664/jcsm.9328
http://www.ncbi.nlm.nih.gov/pubmed/34743789?tool=bestpractice.com
[94]Bassetti CLA, Kallweit U, Vignatelli L, et al. European guideline and expert statements on the management of narcolepsy in adults and children. Eur J Neurol. 2021 Sep;28(9):2815-30.
https://onlinelibrary.wiley.com/doi/10.1111/ene.14888
http://www.ncbi.nlm.nih.gov/pubmed/34173695?tool=bestpractice.com
[95]Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment. J Clin Sleep Med. 2021 Sep 1;17(9):1895-945.
https://jcsm.aasm.org/doi/10.5664/jcsm.9326
http://www.ncbi.nlm.nih.gov/pubmed/34743790?tool=bestpractice.com
Pitolisant improves EDS compared with placebo and is well tolerated compared with modafinil and other pharmacologic agents used in the management of narcolepsy.[95]Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment. J Clin Sleep Med. 2021 Sep 1;17(9):1895-945.
https://jcsm.aasm.org/doi/10.5664/jcsm.9326
http://www.ncbi.nlm.nih.gov/pubmed/34743790?tool=bestpractice.com
[97]Dauvilliers Y, Bassetti C, Lammers GJ, et al. Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial. Lancet Neurol. 2013 Nov;12(11):1068-75.
http://www.ncbi.nlm.nih.gov/pubmed/24107292?tool=bestpractice.com
[98]Romigi A, Vitrani G, Lo Giudice T, et al. Profile of pitolisant in the management of narcolepsy: design, development, and place in therapy. Drug Des Devel Ther. 2018 Aug 30;12:2665-75.
https://www.dovepress.com/profile-of-pitolisant-in-the-management-of-narcolepsy-design-developme-peer-reviewed-article-DDDT
http://www.ncbi.nlm.nih.gov/pubmed/30214155?tool=bestpractice.com
[99]Lehert P, Falissard B. Multiple treatment comparison in narcolepsy: a network meta-analysis. Sleep. 2018 Dec 1;41(12):zsy185.
https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC6289237
http://www.ncbi.nlm.nih.gov/pubmed/30239930?tool=bestpractice.com
[100]Davis CW, Kallweit U, Schwartz JC, et al. Efficacy of pitolisant in patients with high burden of narcolepsy symptoms: pooled analysis of short-term, placebo-controlled studies. Sleep Med. 2021 May;81:210-17.
https://www.doi.org/10.1016/j.sleep.2021.02.037
http://www.ncbi.nlm.nih.gov/pubmed/33721598?tool=bestpractice.com
The efficacy of pitolisant in improving EDS was maintained over a 12-month period in an open-label pragmatic study.[101]Dauvilliers Y, Arnulf I, Szakacs Z, et al. Long-term use of pitolisant to treat patients with narcolepsy: Harmony III Study. Sleep. 2019 Oct 21;42(11):zsz174.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6802569
http://www.ncbi.nlm.nih.gov/pubmed/31529094?tool=bestpractice.com
Sodium oxybate improves EDS and reduces nocturnal sleep disruption.[95]Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment. J Clin Sleep Med. 2021 Sep 1;17(9):1895-945.
https://jcsm.aasm.org/doi/10.5664/jcsm.9326
http://www.ncbi.nlm.nih.gov/pubmed/34743790?tool=bestpractice.com
[102]Xu XM, Wei YD, Liu Y, et al. Gamma-hydroxybutyrate (GHB) for narcolepsy in adults: an updated systematic review and meta-analysis. Sleep Med. 2019 Dec;64:62-70.
http://www.ncbi.nlm.nih.gov/pubmed/31671326?tool=bestpractice.com
[103]Kushida CA, Shapiro CM, Roth T, et al. Once-nightly sodium oxybate (FT218) demonstrated improvement of symptoms in a phase 3 randomized clinical trial in patients with narcolepsy. Sleep. 2022 Jun 13;45(6):zsab200.
https://www.doi.org/10.1093/sleep/zsab200
http://www.ncbi.nlm.nih.gov/pubmed/34358324?tool=bestpractice.com
A multiple-salt oxybate formulation (calcium oxybate/magnesium oxybate/potassium oxybate/sodium oxybate) that reduces patient exposure to sodium is approved in the US for the treatment of EDS.[104]Bogan RK, Thorpy MJ, Dauvilliers Y, et al. Efficacy and safety of calcium, magnesium, potassium, and sodium oxybates (lower-sodium oxybate [LXB]; JZP-258) in a placebo-controlled, double-blind, randomized withdrawal study in adults with narcolepsy with cataplexy. Sleep. 2021 Mar 12;44(3):zsaa206.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7953213
http://www.ncbi.nlm.nih.gov/pubmed/33184650?tool=bestpractice.com
[105]Thorpy MJ. Recently approved and upcoming treatments for narcolepsy. CNS Drugs. 2020 Jan;34(1):9-27.
https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC6982634
http://www.ncbi.nlm.nih.gov/pubmed/31953791?tool=bestpractice.com
[106]Dauvilliers Y, Bogan RK, Šonka K, et al. Calcium, magnesium, potassium, and sodium oxybates oral solution: a lower-sodium alternative for cataplexy or excessive daytime sleepiness associated with narcolepsy. Nat Sci Sleep. 2022;14:531-46.
https://www.doi.org/10.2147/NSS.S279345
http://www.ncbi.nlm.nih.gov/pubmed/35378745?tool=bestpractice.com
In phase 3 trials of patients with narcolepsy, solriamfetol increased sleep latency and reduced Epworth Sleepiness Scale scores after 12 weeks' treatment.[107]Thorpy MJ, Shapiro C, Mayer G, et al. A randomized study of solriamfetol for excessive sleepiness in narcolepsy. Ann Neurol. 2019 Mar;85(3):359-70.
https://onlinelibrary.wiley.com/doi/full/10.1002/ana.25423
http://www.ncbi.nlm.nih.gov/pubmed/30694576?tool=bestpractice.com
Longer-term (up to 50 weeks) maintenance of the efficacy of solriamfetol has been demonstrated.[108]Malhotra A, Shapiro C, Pepin JL. Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea. Sleep. 2020 Feb 13;43(2):zsz220.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7315408
http://www.ncbi.nlm.nih.gov/pubmed/31691827?tool=bestpractice.com
Other options with evidence of effectiveness in treating EDS and a likely favorable balance of benefits and harms include armodafinil (the R-enantiomer of modafinil, which has a longer half-life), methylphenidate, and dextroamphetamine.[93]Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021 Sep 1;17(9):1881-93.
https://jcsm.aasm.org/doi/10.5664/jcsm.9328
http://www.ncbi.nlm.nih.gov/pubmed/34743789?tool=bestpractice.com
[94]Bassetti CLA, Kallweit U, Vignatelli L, et al. European guideline and expert statements on the management of narcolepsy in adults and children. Eur J Neurol. 2021 Sep;28(9):2815-30.
https://onlinelibrary.wiley.com/doi/10.1111/ene.14888
http://www.ncbi.nlm.nih.gov/pubmed/34173695?tool=bestpractice.com
[95]Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment. J Clin Sleep Med. 2021 Sep 1;17(9):1895-945.
https://jcsm.aasm.org/doi/10.5664/jcsm.9326
http://www.ncbi.nlm.nih.gov/pubmed/34743790?tool=bestpractice.com
Short-acting methylphenidate or other stimulants may be used in combination with modafinil or armodafinil. Methamphetamine is considered a last-resort option because of high potency and abuse potential.
A lack of head-to-head trials makes it difficult to compare efficacy between different drugs. Treatment choices may change, and be affected by factors such as age, lifestyle, severity of the condition, drug tolerance, and comorbidities (including risk of dependency or drug misuse). Pharmacologic treatment may lead to rebound sleepiness. It is recommended that clinicians regularly discuss and assess treatment efficacy and safety during follow-up visits.[93]Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021 Sep 1;17(9):1881-93.
https://jcsm.aasm.org/doi/10.5664/jcsm.9328
http://www.ncbi.nlm.nih.gov/pubmed/34743789?tool=bestpractice.com
[94]Bassetti CLA, Kallweit U, Vignatelli L, et al. European guideline and expert statements on the management of narcolepsy in adults and children. Eur J Neurol. 2021 Sep;28(9):2815-30.
https://onlinelibrary.wiley.com/doi/10.1111/ene.14888
http://www.ncbi.nlm.nih.gov/pubmed/34173695?tool=bestpractice.com
Treatment of cataplexy in adults
Sodium oxybate or pitolisant is recommended as first-line treatment for cataplexy.[93]Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021 Sep 1;17(9):1881-93.
https://jcsm.aasm.org/doi/10.5664/jcsm.9328
http://www.ncbi.nlm.nih.gov/pubmed/34743789?tool=bestpractice.com
[94]Bassetti CLA, Kallweit U, Vignatelli L, et al. European guideline and expert statements on the management of narcolepsy in adults and children. Eur J Neurol. 2021 Sep;28(9):2815-30.
https://onlinelibrary.wiley.com/doi/10.1111/ene.14888
http://www.ncbi.nlm.nih.gov/pubmed/34173695?tool=bestpractice.com
[95]Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment. J Clin Sleep Med. 2021 Sep 1;17(9):1895-945.
https://jcsm.aasm.org/doi/10.5664/jcsm.9326
http://www.ncbi.nlm.nih.gov/pubmed/34743790?tool=bestpractice.com
The multiple-salt oxybate formulation reduced the weekly number of cataplexy attacks compared with placebo in a double-blind, randomized trial of adult patients with narcolepsy with cataplexy.[104]Bogan RK, Thorpy MJ, Dauvilliers Y, et al. Efficacy and safety of calcium, magnesium, potassium, and sodium oxybates (lower-sodium oxybate [LXB]; JZP-258) in a placebo-controlled, double-blind, randomized withdrawal study in adults with narcolepsy with cataplexy. Sleep. 2021 Mar 12;44(3):zsaa206.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7953213
http://www.ncbi.nlm.nih.gov/pubmed/33184650?tool=bestpractice.com
One study found that pitolisant reduced the number of cataplexy attacks each week, from baseline to the stable dosing period, by 75% compared with 38% in patients receiving placebo.[109]Szakacs Z, Dauvilliers Y, Mikhaylov V, et al. Safety and efficacy of pitolisant on cataplexy in patients with narcolepsy: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017 Mar;16(3):200-7.
http://www.ncbi.nlm.nih.gov/pubmed/28129985?tool=bestpractice.com
The efficacy of pitolisant in reducing cataplexy attacks was maintained over a 12-month period.[101]Dauvilliers Y, Arnulf I, Szakacs Z, et al. Long-term use of pitolisant to treat patients with narcolepsy: Harmony III Study. Sleep. 2019 Oct 21;42(11):zsz174.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6802569
http://www.ncbi.nlm.nih.gov/pubmed/31529094?tool=bestpractice.com
Antidepressants such as serotonin-norepinephrine-reuptake inhibitors (e.g., venlafaxine), tricyclic antidepressants (TCAs; e.g., clomipramine), selective norepinephrine-reuptake inhibitors (e.g., atomoxetine), or selective serotonin-reuptake inhibitors (SSRIs) may be used as second-line treatment for cataplexy, although evidence for effectiveness is limited.[93]Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021 Sep 1;17(9):1881-93.
https://jcsm.aasm.org/doi/10.5664/jcsm.9328
http://www.ncbi.nlm.nih.gov/pubmed/34743789?tool=bestpractice.com
[94]Bassetti CLA, Kallweit U, Vignatelli L, et al. European guideline and expert statements on the management of narcolepsy in adults and children. Eur J Neurol. 2021 Sep;28(9):2815-30.
https://onlinelibrary.wiley.com/doi/10.1111/ene.14888
http://www.ncbi.nlm.nih.gov/pubmed/34173695?tool=bestpractice.com
[95]Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment. J Clin Sleep Med. 2021 Sep 1;17(9):1895-945.
https://jcsm.aasm.org/doi/10.5664/jcsm.9326
http://www.ncbi.nlm.nih.gov/pubmed/34743790?tool=bestpractice.com
[110]Vignatelli L, D'Alessandro R, Candelise L. Antidepressant drugs for narcolepsy. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD003724.
http://www.ncbi.nlm.nih.gov/pubmed/18254030?tool=bestpractice.com
SSRIs have been associated with an increased risk of suicidality in children, adolescents, and young adults with major depressive or other psychiatric disorders. TCAs have significant anticholinergic effects.
If the patient has coexisting depressive symptoms, or if the abuse potential of oxybates may pose a problem, it is reasonable to use any of these drugs as first-line therapy.
Monoamine oxidase inhibitors (MAOIs) are rarely used, and evidence for efficacy is inconclusive. They are considered a last-line therapy for people whose cataplexy is resistant to other agents, due to their significant drug-drug interactions and adverse effects.[95]Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment. J Clin Sleep Med. 2021 Sep 1;17(9):1895-945.
https://jcsm.aasm.org/doi/10.5664/jcsm.9326
http://www.ncbi.nlm.nih.gov/pubmed/34743790?tool=bestpractice.com
Specialist consultation is required for use of MAOIs in cataplexy.
Antidepressants can be used to treat hypnagogic/hypnopompic hallucinations and sleep paralysis. Advice regarding avoidance of triggers is important.
Treatment of children with narcolepsy
All children and their parents or caregivers should be advised about sleep hygiene measures, with a recommended 9-hour duration or more of total nocturnal sleep.[5]Guilleminault C, Fromherz S. Narcolepsy: diagnosis and management. In: Kryger MH, Roth T, Dement WC, eds. Principles and practice of sleep medicine. 4th ed. Philadelphia, PA: Elsevier Saunders; 2005. Scheduled naps are usually taken at lunchtime or in the afternoon. It is advisable to contact and educate school staff about narcolepsy.[111]Avis KT, Shen J, Weaver P, et al. Psychosocial characteristics of children with central disorders of hypersomnolence versus matched healthy children. J Clin Sleep Med. 2015 Nov 15;11(11):1281-8.
https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC4623126
http://www.ncbi.nlm.nih.gov/pubmed/26285115?tool=bestpractice.com
Advice about avoidance of triggers of cataplexy is also important.
Children whose narcolepsy is not controlled by nonpharmacologic interventions are treated with medicines; however, the evidence base is limited. Sodium oxybate is recommended for the treatment of EDS and cataplexy in children.[93]Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021 Sep 1;17(9):1881-93.
https://jcsm.aasm.org/doi/10.5664/jcsm.9328
http://www.ncbi.nlm.nih.gov/pubmed/34743789?tool=bestpractice.com
[94]Bassetti CLA, Kallweit U, Vignatelli L, et al. European guideline and expert statements on the management of narcolepsy in adults and children. Eur J Neurol. 2021 Sep;28(9):2815-30.
https://onlinelibrary.wiley.com/doi/10.1111/ene.14888
http://www.ncbi.nlm.nih.gov/pubmed/34173695?tool=bestpractice.com
[95]Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment. J Clin Sleep Med. 2021 Sep 1;17(9):1895-945.
https://jcsm.aasm.org/doi/10.5664/jcsm.9326
http://www.ncbi.nlm.nih.gov/pubmed/34743790?tool=bestpractice.com
Sodium oxybate and the multiple-salt formulation are approved in the US for the treatment of EDS and cataplexy in patients from age 7 years with narcolepsy. Sodium oxybate is approved in Europe for the treatment of narcolepsy with cataplexy in patients from age 7 years. No specific medications have received approval to treat narcolepsy in patients <7 years in the US. However, pitolisant is approved in children ≥6 years of age in Europe.[112]Dauvilliers Y, Lecendreux M, Lammers GJ, et al. Safety and efficacy of pitolisant in children aged 6 years or older with narcolepsy with or without cataplexy: a double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2023 Apr;22(4):303-11.
http://www.ncbi.nlm.nih.gov/pubmed/36931805?tool=bestpractice.com
Other treatment options for children include modafinil or methylphenidate for EDS, and antidepressants (e.g., fluoxetine, venlafaxine, and clomipramine) for cataplexy.
Very close attention must be paid to safety and to the risk:benefit ratio of any pharmacologic treatment for narcolepsy in children. Any medications that have not been approved for this indication and age group should be prescribed under specialist guidance only. SSRIs have been associated with an increased risk of suicidality in children, adolescents, and young adults with major depressive or other psychiatric disorders.